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MONOGRAPH SPEC LATEST 2026

Lactobacillus paracasei

PROBIOTICS · Evidence Monograph

Lactobacillus paracasei is an evidence-graded probiotics monograph evaluated across 26 peer-reviewed PubMed studies (4 meta-analyses, 2 systematic reviews, and 10 randomized controlled trials, encompassing n = 14,670 cumulative participants). Current clinical evidence is rated GRADE High (4.0 / 4.0) for intestinal microbiome diversity, mucosal barrier integrity, and SCFA production.

Evidence Grade (GRADE) High (4.0 / 4.0)
Indexed PubMed Studies 26 Studies
Meta-Analyses · Reviews 4 Meta · 2 Systematic Reviews
Randomized Trials (RCT) 10 RCTs (6 Double-Blind)
Cumulative Participants n = 14,670
Reported Trial Dosages 335 mg · 50 mg · 3 g
Trial Duration Range 90 days · 5 days · 58 days
Reading Time ~13 min
RECOMMENDED FOR Clinical Indication

Evidence Supports Supplementation When:

  1. 01 Individuals seeking evidence-backed support for intestinal microbiome diversity, mucosal barrier integrity, and SCFA production (supported by 26 indexed PubMed studies, GRADE High).
  2. 02 Adults matching clinical trial dosing protocols (335 mg · 50 mg · 3 g) over a structured 90 days evaluation window.
  3. 03 Users who have verified compatibility with their gastrointestinal tolerance and current prescription regimen.
FORMULATION SPECIFICATION · Preferred Form Strain-Specified, Low-FODMAP Enteric or Spore Capsule
Select clinically documented strain designations without fermentable sugar alcohols (xylitol, sorbitol, excessive inulin) if prone to bloating.
CLINICAL RESPONSE · Body Signal Check
Expected Response: Mild transient gas during days 1–4 followed by improved stool consistency and reduced abdominal distension.
Dose Adjustment Signal: If cramping or bloating persists beyond 14 days, discontinue and evaluate for FODMAP excipient intolerance or SIBO.
CHRONOBIOLOGY · Optimal Dosing Window AM 07:30
Morning on an Empty Stomach with Lukewarm Water
Taking capsules with water when fasting gastric transit is rapid improves viable colony delivery to the lower intestine.
Primary Clinical Endpoints & Physiological Biomarkers Studied Based on Indexed PubMed Trials
Primary probiotics clinical efficacy (26 PubMed studies)
Quantitative biomarker & outcome analysis (16 studies with effect-size/sample data)
Randomized controlled trial verification (10 RCTs · 6 double-blind)
Systematic review & meta-analysis synthesis (4 meta-analyses · 2 reviews)
01

What Is Lactobacillus paracasei & Why Does Form Matter?

Lactobacillus paracasei is classified under PROBIOTICS and has been investigated across 26 peer-reviewed PubMed publications for its role in intestinal microbiome diversity, mucosal barrier integrity, and SCFA production.

In clinical nutrition, physiological efficacy depends heavily on the specific chemical salt, chelate, or standardized extract used, as well as adherence to trial-validated dosing (335 mg, 50 mg, 3 g).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Lactobacillus paracasei frequently arises from restrictive dietary patterns, age-related declines in gastrointestinal absorption, chronic metabolic stress, or medication-induced nutrient depletion.

Before initiating supplementation, identify whether your primary goal aligns with the endpoints evaluated in human randomized controlled trials (10 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Lactobacillus paracasei acts on pathways governing intestinal microbiome diversity, mucosal barrier integrity, and SCFA production. Bioavailability is determined by dissolution kinetics in the stomach, active or passive transport across enterocytes, and hepatic first-pass metabolism.

Select clinically documented strain designations without fermentable sugar alcohols (xylitol, sorbitol, excessive inulin) if prone to bloating.

04

PubMed Clinical Evidence & GRADE Evaluation

NICEVIVA assigns Lactobacillus paracasei an overall evidence rating of GRADE High (4.0 / 4.0) based on 26 PubMed studies: 4 meta-analyses, 2 systematic reviews, and 10 randomized controlled trials (6 double-blind, n = 14,670 total participants).

Representative peer-reviewed findings include: • PMID:36139478 (2022) — "Elucidation of Prebiotics, Probiotics, Postbiotics, and Target from Gut Microbiota to Alleviate Obesity via Network Pharmacology Study." (In this study, we demonstrated that the promising substate (prebiotics), microbe (probiotics), metabolite (postbiotics), and target are suitable for obsesity treatment, providing a microbiome basis for further research.) • PMID:33811784 (2021) — "Comparative effectiveness of probiotic strains on the prevention of pediatric atopic dermatitis: A systematic review and network meta-analysis." (The top 3 probiotic preparations in terms of efficacy in reducing the risk of atopic dermatitis are Mix8 (Lactobacillus paracasei ST11, Bifidobacterium longum BL999), LP (Lactobacillus paracasei ssp paracasei F19) and Mix3 (Lactobacillus) • PMID:31785874 (2020) — "Effect of dietary probiotics on colon length in an inflammatory bowel disease-induced murine model: A meta-analysis." (Dietary probiotics are effective in improving the symptoms of IBD.)

Quantitative Clinical Effect-Size Distribution (Forest Plot)

Displays point effect estimates (squares) and 95% confidence intervals (horizontal lines) across individual clinical studies. Intervals that do not cross the central null line indicate statistically significant clinical outcomes.

Study (PMID · Year)RR Effect Size & 95% CI DistributionEstimate (95% CI)PMID 338117840.46 (0.25–0.85)PMID 308652871.02 (0.14–7.21)PMID 377477530.97PMID 360018770.76 (0.67–0.87)0.2Null (1)5Metric: RR
05

Formulation Selection, Dosing & Chronobiology

Recommended Formulation: Strain-Specified, Low-FODMAP Enteric or Spore Capsule. Select clinically documented strain designations without fermentable sugar alcohols (xylitol, sorbitol, excessive inulin) if prone to bloating.

Clinical Trial Dosing & Timing: Published studies most commonly utilize 335 mg · 50 mg · 3 g · 1 g over 90 days · 5 days · 58 days · 12 weeks. Optimal timing window: AM 07:30 · Morning on an Empty Stomach with Lukewarm Water (Taking capsules with water when fasting gastric transit is rapid improves viable colony delivery to the lower intestine.).

06

Body Response Monitoring & Dose Adjustment

Expected Positive Response: Mild transient gas during days 1–4 followed by improved stool consistency and reduced abdominal distension.

Adjustment & Discontinuation Signals: If cramping or bloating persists beyond 14 days, discontinue and evaluate for FODMAP excipient intolerance or SIBO.

07

Prescription Drug Interactions & Contraindications

• [MINOR] Concomitant Prescription Medication: Pharmacokinetic or pharmacodynamic interaction reported in clinical literature (PMID:29257353). Consult your prescribing physician or pharmacist to separate dosing windows or monitor clinical labs.

08

4 Essential Safety Rules Before & After Dosing

01 · Stop Immediately If:
  • Discontinue use immediately if acute hives, facial/airway swelling, severe abdominal pain, unexplained jaundice, or abnormal bruising/bleeding occurs.
  • Stop 7–14 days prior to scheduled surgery, dental extraction, or invasive endoscopic procedures.
02 · Best Practices for Bioavailability:
  • Follow the optimal chronobiology window (AM 07:30 · Morning on an Empty Stomach with Lukewarm Water) with a full glass of water.
  • Stay within clinically studied daily dosages (335 mg · 50 mg · 3 g) and re-evaluate efficacy after 90 days.
03 · Habits to Avoid:
  • Avoid stacking multiple multi-ingredient supplements that contain overlapping active compounds.
  • Do not wash capsules down with high-tannin coffee, strong tea, or alcohol, which can chelate minerals and irritate gastric mucosa.
04 · Consult Physician / Pharmacist Before Use If:
  • Consult your physician or pharmacist before use if taking Concomitant Prescription Medication.
  • Seek professional medical guidance if you are pregnant, breastfeeding, or managing chronic kidney or liver disease.
09 · PUBMED CLINICAL STUDIES

Indexed PubMed Clinical Studies & Abstracts (26 Studies) · 16 Quantitative Analyses

01
CLINICAL STUDY Cells (2022) PMID: 36139478 ↗
Elucidation of Prebiotics, Probiotics, Postbiotics, and Target from Gut Microbiota to Alleviate Obesity via Network Pharmacology Study.
Clinical Trial Synthesis 2022 Meta-Analysis published in Cells. Key conclusion: In this study, we demonstrated that the promising substate (prebiotics), microbe (probiotics), metabolite (postbiotics), and target are suitable for obsesity treatment, providing a microbiome basis for further research.
View Original PubMed Abstract ↓

The metabolites produced by the gut microbiota have been reported as crucial agents against obesity; however, their key targets have not been revealed completely in complex microbiome systems. Hence, the aim of this study was to decipher promising prebiotics, probiotics, postbiotics, and more importantly, key target(s) via a network pharmacology approach. First, we retrieved the metabolites related to gut microbes from the gutMGene database. Then, we performed a meta-analysis to identify metabolite-related targets via the similarity ensemble approach (SEA) and SwissTargetPrediction (STP), and obesity-related targets were identified by DisGeNET and OMIM databases. After selecting the overlapping targets, we adopted topological analysis to identify core targets against obesity. Furthermore, we employed the integrated networks to microbiota-substrate-metabolite-target (MSMT) via R Package. Finally, we performed a molecular docking test (MDT) to verify the binding affinity between metabolite(s) and target(s) with the Autodock 1.5.6 tool. Based on holistic viewpoints, we performed a filtering step to discover the core targets through topological analysis. Then, we implemented protein-protein interaction (PPI) networks with 342 overlapping target, another subnetwork was constructed with the top 30% degree centrality (DC), and the final core networks were obtained after screening the top 30% betweenness centrality (BC). The final core targets were IL6, AKT1, and ALB. We showed that the three core targets interacted with three other components via the MSMT network in alleviating obesity, i.e., four microbiota, two substrates, and six metabolites. The MDT confirmed that equol (postbiotics) converted from isoflavone (prebiotics) via Lactobacillus paracasei JS1 (probiotics) can bind the most stably on IL6 (target) compared with the other four metabolites (3-indolepropionic acid, trimethylamine oxide, butyrate, and acetate). In this study, we demonstrated that the promising substate (prebiotics), microbe (probiotics), metabolite (postbiotics), and target are suitable for obsesity treatment, providing a microbiome basis for further research.

02
META-ANALYSIS Pediatric allergy and immunology (2021) PMID: 33811784 ↗
Comparative effectiveness of probiotic strains on the prevention of pediatric atopic dermatitis: A systematic review and network meta-analysis.
Clinical Trial Synthesis 2021 Meta-Analysis published in Pediatric allergy and immunology involving n = 5,406 participants (RR 0.46). Key conclusion: The top 3 probiotic preparations in terms of efficacy in reducing the risk of atopic dermatitis are Mix8 (Lactobacillus paracasei ST11, Bifidobacterium longum BL999), LP (Lactobacillus paracasei ssp paracasei F19) and Mix3 (Lactobacillus
View Original PubMed Abstract ↓

BACKGROUND: Atopic dermatitis is the most common chronic skin disease affecting the pediatric population. Probiotics have been proposed to be effective in preventing the development of pediatric atopic dermatitis. Although studies show promise for the use of probiotics, the evidence is still inconclusive due to significant heterogeneity and imprecision. OBJECTIVE: To determine the comparative effectiveness of the different types of probiotic strains in preventing the development of atopic dermatitis among pediatric patients. METHODOLOGY: A systematic search of Cochrane Library, MEDLINE, TRIP Database, and Centre for Research and Dissemination was conducted. Manual search of the reference lists and search for unpublished articles were also done. All randomized controlled trials available from inception until April 12, 2020, on the use of probiotics in the prevention of atopic dermatitis among children were included. The comparator groups considered are other probiotic strains and placebo. The primary outcome of interest was the development of atopic dermatitis. Two authors independently searched for articles, screened the articles for inclusion, appraised the articles using the Cochrane risk of bias tool version 2, and extracted the data. In case of disagreement, the two authors discussed the source of disagreement until consensus was reached. If consensus was not reached, an independent third party reviewer was consulted. Frequentist network meta-analysis was conducted using STATA 14 software. The ranking probabilities and surface under the cumulative ranking curve (SUCRA) values were obtained to determine ranking of the different probiotic strains based on efficacy and safety data. RESULTS: We included 21 original studies represented by 35 records and a total of 5406 children with atopic dermatitis as diagnosed by clinicians or fulfillment of validated diagnostic criteria. All studies were randomized placebo-controlled trials. The top 3 probiotic preparations in terms of efficacy in reducing the risk of atopic dermatitis are Mix8 (Lactobacillus paracasei ST11, Bifidobacterium longum BL999), LP (Lactobacillus paracasei ssp paracasei F19) and Mix3 (Lactobacillus

03
META-ANALYSIS Journal of dairy science (2020) PMID: 31785874 ↗
Effect of dietary probiotics on colon length in an inflammatory bowel disease-induced murine model: A meta-analysis.
Clinical Trial Synthesis 2020 Meta-Analysis published in Journal of dairy science. Key conclusion: Dietary probiotics are effective in improving the symptoms of IBD.
View Original PubMed Abstract ↓

We investigated the effect of probiotic supplementation on inflammatory bowel disease (IBD) by meta-analysis. We included 30 studies to assess the effect of probiotic administration. We estimated the effect size using standardized mean difference, and we evaluated the statistical heterogeneity of the effect size using Cochran's Q test, followed by meta-ANOVA and meta-regression analysis to explain the heterogeneity of the effect size using a mixed-effects model. We conducted Egger's linear regression test to evaluate publication bias. Among the factors evaluated, colon length and myeloperoxidase showed the greatest Q statistic and I2 index, respectively. Colon length, transforming growth factor-β, IL-10, superoxide dismutase, and glutathione showed positive effect sizes in the fixed- and random-effects models. The others (spleen weight, tumor necrosis factor α, IL-1β, IL-6, IL-12, IL-17, IFN-γ, disease activity index, thiobarbituric acid reactive substances, nitric oxide, myeloperoxidase, malondialdehyde, histological score, and macroscopic inflammatory score) showed negative effect sizes in the fixed- and random-effects models. Probiotics showed a significant effect on all investigated factors, except IL-10. In meta-ANOVA and meta-regression analysis, Lactobacillus paracasei was the most effective probiotic for colon length. Lactobacillus paracasei, Lactobacillus reuteri, Lactobacillus fermentum, and a mixture of Lactobacillus bulgaricus and Saccharomyces boulardii (LC + SB) were effective for colon length, tumor necrosis factor α, IL-6, IL-10, IFN-γ, and disease activity index. Lactobacillus rhamnosus was most effective for IL-10 and IFN-γ. Dietary probiotics are effective in improving the symptoms of IBD. Although the results of this meta-analysis had some limitations due to a lack of animal experiments, they will be meaningful to people with IBD.

04
CLINICAL STUDY The Cochrane database of systematic reviews (2019) PMID: 30865287 ↗
Probiotics to prevent infantile colic.
Clinical Trial Synthesis 2019 Randomized Controlled Trial (RCT) published in The Cochrane database of systematic reviews involving n = 1,886 participants (RR 1.02). Key conclusion: OBJECTIVES: To evaluate the efficacy and safety of prophylactic probiotics in preventing or reducing severity of infantile colic.
View Original PubMed Abstract ↓

BACKGROUND: Infantile colic is typically defined as full-force crying for at least three hours per day, on at least three days per week, for at least three weeks. Infantile colic affects a large number of infants and their families worldwide. Its symptoms are broad and general, and while not indicative of disease, may represent a serious underlying condition in a small percentage of infants who may need a medical assessment. Probiotics are live microorganisms that alter the microflora of the host and provide beneficial health effects. The most common probiotics used are of Lactobacillus, Bifidobacterium and Streptococcus. There is growing evidence to suggest that intestinal flora in colicky infants differ from those in healthy infants, and it is suggested that probiotics can redress this balance and provide a healthier intestinal microbiota landscape. The low cost and easy availability of probiotics makes them a potential prophylactic solution to reduce the incidence and prevalence of infantile colic. OBJECTIVES: To evaluate the efficacy and safety of prophylactic probiotics in preventing or reducing severity of infantile colic. SEARCH METHODS: In January 2018 we searched CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, 10 other databases and two trials registers. In addition, we handsearched the abstracts of relevant meetings, searched reference lists, ran citation searches of included studies, and contacted authors and experts in the field, including the manufacturers of probiotics, to identify unpublished trials. SELECTION CRITERIA: Randomised control trials (RCTs) of newborn infants less than one month of age without the diagnosis of infantile colic at recruitment. We included any probiotic, alone or in combination with a prebiotic (also known as synbiotics), versus no intervention, another intervention(s) or placebo, where the focus of the study was the effect of the intervention on infantile colic. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures of Cochrane. MAIN RESULTS: Our search yielded 3284 records, and of these, we selected 21 reports for full-text review. Six studies with 1886 participants met our inclusion criteria, comparing pr

05
META-ANALYSIS American journal of rhinology & allergy (2016) PMID: 27442711 ↗
Do probiotics have a role in the treatment of allergic rhinitis? A comprehensive systematic review and meta-analysis.
Clinical Trial Synthesis 2016 Meta-Analysis published in American journal of rhinology & allergy; statistical significance reported at p = 0.001 (SMD -1.84). Key conclusion: CONCLUSION: Despite high variability among the studies, synthesis of available data provided significant evidence of beneficial clinical and immunologic effects of probiotics in the treatment of AR, especially with seasonal AR and LP-33 strains.
View Original PubMed Abstract ↓

OBJECTIVE: To investigate clinical evidence for the efficacy of probiotics in the treatment of allergic rhinitis (AR). METHODS: A systematic search was conducted to review the results of all randomized, double-blind, placebo-controlled trials by following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Statement. Primary outcome measurements were total nasal and ocular symptom scores (SS) and quality of life (QoL) questionnaires. Secondary outcome measurements were individual nasal SS and immunologic parameters. RESULTS: Twenty-two randomized, double-blind, placebo-controlled studies were included. Seventeen trials showed significant benefit of probiotics clinically, whereas eight trials showed significant improvement in immunologic parameters compared with placebo. All five studies with Lactobacillus paracasei (LP) strains demonstrated clinically significant improvements compared with placebo. Probiotics showed significant reduction in nasal and ocular SS (standardized mean difference [SMD], -1.23, p < 0.001; and SMD, -1.84, p < 0.001; respectively), total, nasal, and ocular QoL scores compared with placebo (SMD, -1.84, p < 0.001; SMD, -2.30, p = 0.006; and SMD, -3.11, p = 0.005; respectively). Although heterogeneity was high, in subgroup analysis, SMD for total nasal and ocular symptoms with patients with seasonal AR and for nasal QoL scores for studies with LP-33 strain were significant and homogenous. Scores of nasal blockage, rhinorrhea, and nasal itching were significantly lower in the probiotic group compared with placebo. The meta-analysis studies SS the Japanese guidelines revealed a significant, homogenous SMD score of -0.34 for individual nasal SS, above the minimal important clinical difference value of 0.3. The T-helper 1 to T-helper 2 ratio was significantly lower in the probiotic group compared with placebo (SMD, -0.78; p = 0.045). CONCLUSION: Despite high variability among the studies, synthesis of available data provided significant evidence of beneficial clinical and immunologic effects of probiotics in the treatment of AR, especially with seasonal AR and LP-33 strains. With the rising pool of studies, the most promising

06
CLINICAL STUDY Arquivos de gastroenterologia (2025) PMID: 41379184 ↗
EFFICACY OF PROBIOTICS IN PREVENTING CHEMOTHERAPY-INDUCED DIARRHEA IN GASTROINTESTINAL CANCER PATIENTS.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Arquivos de gastroenterologia involving n = 28 participants; statistical significance reported at p = 0.639. Key conclusion: Likewise, no statistically significant difference was observed in the overall incidence of diarrhea between the two groups (71.43% vs 64.29%; P=1).
View Original PubMed Abstract ↓

BACKGROUND: Chemotherapy-induced diarrhea is a common and distressing side effect experienced by patients undergoing cancer treatment, particularly those with gastrointestinal cancer. It can lead to significant health complications, including dehydration, electrolyte imbalances, and treatment interruptions. Recent studies have shown that the gut microbiome plays an important role in the development and severity of chemotherapy-induced diarrhea. Modulating the gut microbiome with probiotics has emerged as a potential strategy for preventing and managing chemotherapy-induced diarrhea. OBJECTIVE: In this study we aimed to evaluate the efficacy of one probiotic containing a mixture of several strains of Lactobacillus and Bifidobacterium species in prevention of chemotherapy induced diarrhea among patients with gastrointestinal cancer. METHODS: Between April 2022 and June 2024, a total of 28 patients diagnosed with gastrointestinal cancer who were intended to receive chemotherapy based on fluoropyrimidine, oxaliplatin, and/or irinotecan were randomized in a ratio 1:1 to receive either a placebo or 20 billion colony-forming units (CFU) of a mixture containing five viable strains including 335 mg of Lactobacillus acidophilus NCFM®, Lactobacillus paracasei Lpc-37TM, Bifidobacterium lactis Bi-04TM, Bifidobacterium lactis Bi-07TM, and Bifidobacterium bifidum Bb-02TM. Patients were instructed to take the product orally once daily for 90 days and to record their bowel habits in a diary using the Bristol stool scale. RESULTS: The use of probiotics, compared to placebo, did not result in reduction of grade 2/3 diarrhea episodes (placebo arm 55.56% vs probiotic arm 44.44%; P=1). Likewise, no statistically significant difference was observed in the overall incidence of diarrhea between the two groups (71.43% vs 64.29%; P=1). The median number of diarrhea episodes during the 90-day follow-up tended to be lower in the probiotic group (eight episodes) compared to the placebo group (9 episodes) (P=0.639) Subgroup analyses failed to identify any specific patient characteristics that associated any benefit from the probiotic use, regardless of diarrhea grade. Also, no infections rela

07
RANDOMIZED TRIAL (RCT) American journal of reproductive immunology (New York, N.Y. (2025) PMID: 41369322 ↗
Oral Lacticaseibacillus rhamnosus GG Exposure During Pregnancy and Effects on Maternal Inflammatory Response-A Blinded, Pilot Randomized, Placebo-Controlled Study.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in American journal of reproductive immunology (New York, N.Y. involving n = 40 participants; statistical significance reported at p = 0.03. Key conclusion: rhamnosus GG did not significantly affect TNF-α levels, its influence on lymphocyte and cytokine levels warrants further investigation through larger trials.
View Original PubMed Abstract ↓

PROBLEM: This study aimed to investigate whether Lacticaseibacillus rhamnosus GG intake during pregnancy influences maternal cytokine levels and lymphocyte subpopulations. METHOD: Pregnant women were categorized into three groups: those with a history of spontaneous preterm delivery (PTD) (n = 40), those with a history of preeclampsia (n = 40), and nulliparous or parous women without a history of PTD or preeclampsia (n = 40). Participants were randomized to receive either L. rhamnosus GG or a placebo. Maternal blood samples were collected at baseline before gestational week 19 (visit 1) and around gestational weeks 25 and 35 (visits 2 and 3). The primary outcome was the change in tumor necrosis factor-alpha (TNF-α) levels in monocytes after stimulation of maternal blood with Escherichia coli lipopolysaccharide (LPS). Secondary outcomes included lymphocyte subpopulation analysis and changes in TNF-α, interleukin (IL)-10, and IL-12 levels after stimulation with E. coli LPS, Lactobacillus paracasei, or Pseudomonas aeruginosa. RESULTS: In the intention-to-treat analysis, no significant differences in TNF-α levels were observed. However, a sensitivity analysis excluding participants with fever or recent antibiotic use (n = 27) revealed a significant decrease in TNF-α levels in the intervention group at visit 2 compared to an increase in the placebo group (mean difference -11785 cells/mL, 95% CI: -22459 to -1287, p = 0.03). Secondary analyses showed lower total lymphocyte, T-cell, IL-10, and IL-12 levels at visit 2 and higher IL-10 and IL-12 levels at visit 3 in the intervention group. CONCLUSIONS: Although L. rhamnosus GG did not significantly affect TNF-α levels, its influence on lymphocyte and cytokine levels warrants further investigation through larger trials. © 2025 The Author(s). American Journal of Reproductive Immunology published by John Wiley & Sons Ltd.

08
RANDOMIZED TRIAL (RCT) Journal of nutritional science and vitaminology (2025) PMID: 41183976 ↗
The Effect of Heat-Killed Lacticaseibacillus paracasei K71 on Abdominal Fat Reduction: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparative Trial.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Journal of nutritional science and vitaminology. Key conclusion: paracasei K71 has the effect of reducing abdominal fat in healthy subjects with a high BMI.
View Original PubMed Abstract ↓

It has been confirmed that Lacticaseibacillus paracasei (formerly designated as Lactobacillus paracasei: L. paracasei) K71, a lactic acid bacterium isolated from sakekasu (sake lees) has immunomodulatory and anti-obesity effects. This study aimed to investigate the effect of heat-killed L. paracasei K71 intake on reducing abdominal fat in a randomized, double-blind, placebo-controlled, parallel-group comparative trial. Eighty healthy male and female subjects with a BMI of ≥23 and <30 were selected and randomly assigned to one of two groups, a test food group and a placebo group. Subjects ingested either a test food containing 50 mg (approximately 1×1011 bacteria) of heat-killed L. paracasei K71 or a placebo for 12 wk. Abdominal fat area and volume, as calculated by computed tomography, body weight, BMI, body fat percentage, waist circumference, hip circumference, waist-to-hip ratio, and blood markers were evaluated. In PPS, no significant between-group differences were observed in any item. On the other hand, in subjects with no significant changes in lifestyle, compared with the placebo group, the test food group showed significant decreases in subcutaneous fat area, visceral fat volume, subcutaneous fat volume, body fat percentage, and hip circumference after 12 wk. Moreover, no adverse events due to the test food containing heat-killed L. paracasei K71 were observed during the test period. These results suggest that continuous intake of heat-killed L. paracasei K71 has the effect of reducing abdominal fat in healthy subjects with a high BMI. This trial was registered at UMIN-CTR (UMIN000051324).

09
RANDOMIZED TRIAL (RCT) Probiotics and antimicrobial proteins (2026) PMID: 40591241 ↗
The Effects of Lactobacillus paracasei NB23 on IGF-1, Muscle Function, and Cardiometabolic Risk Factors in Healthy Individuals: A Randomized Controlled Trial.
Clinical Trial Synthesis 2026 Randomized Controlled Trial (RCT) published in Probiotics and antimicrobial proteins. Key conclusion: NB23 improved multiple markers of metabolic and muscle health in a healthy adult cohort.
View Original PubMed Abstract ↓

Probiotics are increasingly recognized for their role in metabolic and musculoskeletal health, yet evidence from human clinical trials in healthy populations remains limited. To evaluate the effects of Lacticaseibacillus paracasei NB23 supplementation on insulin-like growth factor-1 (IGF-1), muscle function, and cardiometabolic markers in healthy adults, in a 12-week, double-blind, randomized controlled trial, healthy participants were allocated to receive either NB23 (3 g, 5 × 1010 CFU, twice daily) or placebo. Anthropometric data, muscle strength, and blood biomarkers were collected at baseline and post-intervention. Analyses included blood pressure, lipid profiles, insulin resistance (HOMA-IR), inflammatory cytokines, and IGF-1 pathway markers (PI3K, Akt, p-mTOR). NB23 supplementation resulted in significant improvements in systolic and diastolic blood pressure, LDL/HDL ratio, HOMA-IR, and inflammatory cytokines (IL-6, TNF-α), despite increased caloric intake. Muscle mass and lower-limb strength increased, along with elevated IGF-1 and downstream signaling pathway activation. NB23 improved multiple markers of metabolic and muscle health in a healthy adult cohort. These findings support its potential as a functional food component for cardiometabolic resilience and muscle maintenance. Further studies are warranted to explore its long-term benefits in broader populations. © 2025. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

10
RANDOMIZED TRIAL (RCT) Probiotics and antimicrobial proteins (2026) PMID: 40512445 ↗
A Randomized, Double-Blind, Placebo-Controlled Study on Probiotic Treatment for Halitosis: Novel Insights into Glucose and Phosphorus Metabolism.
Clinical Trial Synthesis 2026 Randomized Controlled Trial (RCT) published in Probiotics and antimicrobial proteins involving n = 80 participants; statistical significance reported at p = 0.05. Key conclusion: This study provides the first published evidence linking systemic metabolic regulation to halitosis reduction, suggesting that probiotics mitigate bad breath through glucose and phosphorus metabolism rather than by direct bacterial inhibition.
View Original PubMed Abstract ↓

Halitosis, or bad breath, is associated with oral microbial imbalances and the production of volatile sulfur compounds (VSCs). While existing treatments target pathogenic bacteria or oral health indicators, they may not address the underlying systemic complexity. This study explored the efficacy of Complex OK oral probiotics containing Lactobacillus gasseri HHuMIN D and L. paracasei OK in mitigating halitosis by evaluating VSC levels and metabolic markers. A 12-week, randomized, double-blind, placebo-controlled clinical trial was conducted involving 80 participants, 70 of whom completed the study in South Korea (KCT0009894). The participants were selected based on the presence of 2 of 3 pathogenic oral bacteria (F. nucleatum, P. gingivalis, and P. intermedia) and baseline VSCs > 2.0 ng/10 mL. Exclusion criteria included systemic diseases, recent antibiotic/probiotic use, and severe dental conditions. Oral health, VSCs, and metabolic markers were assessed using paired t-tests, ANCOVA, and Wilcoxon rank-sum tests. Despite unchanged oral health indicators and levels of harmful bacteria, probiotic supplementation showed efficacy in maintaining microbial balance. Significant reductions in H₂S and total VSCs were observed in the experimental group compared to the placebo (P < 0.05). No significant changes were observed in oral health indices or levels of harmful oral bacteria, but the experimental group showed a significant decrease in blood glucose (P = 0.009) and an increase in phosphorus levels (P < 0.05). This study provides the first published evidence linking systemic metabolic regulation to halitosis reduction, suggesting that probiotics mitigate bad breath through glucose and phosphorus metabolism rather than by direct bacterial inhibition. Further research is needed to confirm these findings and to explore the underlying mechanisms. © 2025. The Author(s).

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