NICEVIVA
MONOGRAPH SPEC LATEST 2026

Enterococcus faecium

PROBIOTICS · Evidence Monograph

Enterococcus faecium is an evidence-graded probiotics monograph evaluated across 30 peer-reviewed PubMed studies (4 meta-analyses, 0 systematic reviews, and 10 randomized controlled trials, encompassing n = 7,307 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 30 Studies
Meta-Analyses · Reviews 4 Meta · 0 Systematic Reviews
Randomized Trials (RCT) 10 RCTs (9 Double-Blind)
Cumulative Participants n = 7,307
Reported Trial Dosages 0.5 g · 200 mg · 400 mg
Trial Duration Range 28 days · 12 weeks · 8 weeks
Reading Time ~15 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 30 indexed PubMed studies, GRADE High).
  2. 02 Adults matching clinical trial dosing protocols (0.5 g · 200 mg · 400 mg) over a structured 28 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
cholesterol (PubMed clinical endpoint)
gut (PubMed clinical endpoint)
01

What Is Enterococcus faecium & Why Does Form Matter?

Enterococcus faecium is classified under PROBIOTICS and has been investigated across 30 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 (0.5 g, 200 mg, 400 mg).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Enterococcus faecium 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, Enterococcus faecium 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 Enterococcus faecium an overall evidence rating of GRADE High (4.0 / 4.0) based on 30 PubMed studies: 4 meta-analyses, 0 systematic reviews, and 10 randomized controlled trials (9 double-blind, n = 7,307 total participants).

Representative peer-reviewed findings include: • PMID:38771159 (2024) — "The effectiveness of probiotics as an adjunct therapy in patients under mechanical ventilation: an umbrella systematic review and meta-analysis." (Probiotics significantly decreased ventilator-associated pneumonia (VAP) incidence, nosocomial infections, intensive care unit (ICU) length of stay, hospital length of stay, ICU mortality, hospital mortality, MV duration, duration of antibiotic use, and diarrhea.) • PMID:38693449 (2024) — "Network meta-analysis of probiotics, prebiotics, and synbiotics for the treatment of chronic constipation in adults." (CONCLUSIONS: Moderate to very low evidence supports the use of lactulose and synbiotics to increase the number of weekly stool movements in patients, particularly highlighting the significant impact of synbiotics in increasing the) • PMID:37956795 (2024) — "Effects of probiotics in children with acute gastroenteritis: A systematic review and meta-analysis focusing on probiotics utilized in Japan." (CONCLUSIONS: Although the certainty of evidence is very low, the use of probiotics for acute gastroenteritis in children may improve diarrhea approximately one day earlier.)

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 0.5 g · 200 mg · 400 mg · 64 μg over 28 days · 12 weeks · 8 weeks · 30 days. 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

No major high-risk prescription contraindications are flagged in the primary index for Enterococcus faecium, but divalent minerals, fat-soluble compounds, and botanical extracts can still alter absorption or CYP450 metabolism of concurrent medications.

Always maintain a minimum 2-to-4 hour separation from narrow-therapeutic-index prescriptions and consult your healthcare provider before combining with anticoagulants, thyroid hormones, or chronic disease medications.

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 (0.5 g · 200 mg · 400 mg) and re-evaluate efficacy after 28 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 if you take daily prescription medications for thyroid, cardiovascular, metabolic, or neuropsychiatric conditions.
  • 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 (30 Studies) · 16 Quantitative Analyses

01
META-ANALYSIS Food & function (2024) PMID: 38771159 ↗
The effectiveness of probiotics as an adjunct therapy in patients under mechanical ventilation: an umbrella systematic review and meta-analysis.
Clinical Trial Synthesis 2024 Meta-Analysis published in Food & function. Key conclusion: Probiotics significantly decreased ventilator-associated pneumonia (VAP) incidence, nosocomial infections, intensive care unit (ICU) length of stay, hospital length of stay, ICU mortality, hospital mortality, MV duration, duration of antibiotic use, and diarrhea.
View Original PubMed Abstract ↓

The literature regarding the role of probiotics in critically ill patients who have undergone mechanical ventilation (MV) is unclear; therefore, this umbrella systematic review and meta-analysis was carried out to clarify the effects of probiotics on the clinical outcomes of mechanically ventilated patients. The Scopus, PubMed/Medline, ISI Web of Science, and Google Scholar online databases were searched up to February 2023. All meta-analyses evaluating the impact of probiotics in patients under MV were considered eligible. The assessment of multiple systematic reviews (AMSTAR) questionnaire was used to evaluate the quality of the studies. Data were pooled using the random-effects approach. Thirty meta-analyses and nine clinical outcomes were re-analyzed. Probiotics significantly decreased ventilator-associated pneumonia (VAP) incidence, nosocomial infections, intensive care unit (ICU) length of stay, hospital length of stay, ICU mortality, hospital mortality, MV duration, duration of antibiotic use, and diarrhea. The obtained results of the current umbrella meta-analysis indicate that probiotic administration could be considered an adjunct therapy for critically ill patients; however, no specific probiotic treatment regimen can be recommended due to the diverse probiotics used in the included meta-analyses. The following microorganisms were used at various doses and combinations throughout the studies: Lacticaseibacillus casei, Lactiplantibacillus plantarum, L. acidophilus, L. delbrueckii, L. bulgaricus, Bifidobacterium longum, B. breve, B. salivarius, Pediococcus pentosaceus, Lactococcus raffinolactis, B. infantis, B. bifidum, Streptococcus thermophilus, Ligilactobacillus salivarius, L. lactis, B. lactis, Saccharomyces boulardii, L. rhamnosus GG, L. johnsonii, L. casei, S. faecalis, Clostridium butyricum, Bacillus mesentericus, L. sporogenes, S. boulardii, L. paracasei, B. subtilis, and Enterococcus faecium.

02
META-ANALYSIS European journal of nutrition (2024) PMID: 38693449 ↗
Network meta-analysis of probiotics, prebiotics, and synbiotics for the treatment of chronic constipation in adults.
Clinical Trial Synthesis 2024 Meta-Analysis published in European journal of nutrition involving n = 3,903 participants (MD 3.63). Key conclusion: CONCLUSIONS: Moderate to very low evidence supports the use of lactulose and synbiotics to increase the number of weekly stool movements in patients, particularly highlighting the significant impact of synbiotics in increasing the
View Original PubMed Abstract ↓

OBJECTIVE: To compare the outcomes associated with the use of probiotics, prebiotics, and synbiotics for the treatment of chronic constipation in adults. METHODS: We searched eight electronic databases from database inception to July 11, 2023, to identify randomized controlled trials (RCTs) that report efficacy and safety for the treatment of chronic constipation. The risk of bias in the included RCTs was evaluated according to the Cochrane tool, and the certainty of the evidence was assessed using the Confidence in Network Meta-Analysis framework. The analysis was conducted using R version 4.3.0. RESULTS: Out of the 37 RCTs, a total of 21 different types of interventions were reported, involving 3,903 patients. This NMA demonstrated that both prebiotics and synbiotics resulted in an increase in frequency of stool movements per week. Compared to placebo, lactulose (Mean difference [MD] = 3.39, 95% Confdence interval [CI] [1.13, 5.65], moderate certainty), mix2 (consisting of Lactulose and Bacillus coagulans) (MD = 3.63, 95% CI [1.37, 5.89], moderate certainty), mix6 (consisting of Lactulose and Bifidobacterium coagulans) (MD = 4.30, 95% CI [1.04, 7.54], low certainty), and mix7 (consisting of Lactulose, Bifidobacterium subtilis, and Enterococcus faecium) (MD = 4.58, 95% CI [1.35, 7.78], moderate certainty) exhibited a significant effect. Notably, mix7 demonstrated the highest probability of being the most effective intervention (94.8%). Furthermore, when compared to L. plantarum, four probiotics and two synbiotics showed significant advantages in the Patient Assessment of Constipation Symptoms (PAC-SYM) score. L. reuteri (MD = -13.74, 95% CI [-22.20, -4.66], very low certainty) exhibited a significant effect in improving the Patient Assessment of Constipation Quality of Life (PAC-QoL) score. In terms of safety, there were no statistically significant differences between the intervention and control groups in all adverse event analyses. CONCLUSIONS: Moderate to very low evidence supports the use of lactulose and synbiotics to increase the number of weekly stool movements in patients, particularly highlighting the significant impact of synbiotics in increasing the

03
META-ANALYSIS Journal of infection and chemotherapy (2024) PMID: 37956795 ↗
Effects of probiotics in children with acute gastroenteritis: A systematic review and meta-analysis focusing on probiotics utilized in Japan.
Clinical Trial Synthesis 2024 Meta-Analysis published in Journal of infection and chemotherapy involving n = 878 participants. Key conclusion: CONCLUSIONS: Although the certainty of evidence is very low, the use of probiotics for acute gastroenteritis in children may improve diarrhea approximately one day earlier.
View Original PubMed Abstract ↓

BACKGROUND: Many randomized controlled trials and systematic reviews have evaluated the use of probiotics to treat acute infectious gastroenteritis. However, most probiotic species evaluated in previous large randomized controlled trials are unavailable in Japan. Our objective was to investigate the efficacy of probiotics utilized in Japan for acute gastroenteritis. METHODS: The inclusion criterion was a randomized controlled study that compared probiotics with a placebo to treat children younger than 18 years with acute infectious gastroenteritis. We excluded studies that did not contain the following species available in Japan: Bifidobacterium spp., Lactobacillus acidophilus, Enterococcus faecium, Clostridium butyricum, and Bacillus subtilis and studies in low- or lower-middle-income countries. We searched PubMed, CENTRAL, and Igaku Chuo Zasshi from their inception to November 27, 2022. After the risk of bias assessment, data on diarrhea duration, number of hospitalizations, length of hospital stay, and adverse effects were extracted. RESULTS: Fourteen studies were included in this meta-analysis. Diarrhea lasting longer than 48 h (7 articles, n = 878) was significantly lower in the probiotic group (risk ratio (RR) 0.70, 95 % confidence interval (CI) 0.59-0.83). The duration of diarrhea (14 articles; n = 1761) was 23.45 h (95 % CI 18.22-26.69) shorter in the probiotic group. Duration of hospitalization (6 articles; n = 971) was 17.73 h (95 % CI 6.9-28.56) shorter in the probiotic group. CONCLUSIONS: Although the certainty of evidence is very low, the use of probiotics for acute gastroenteritis in children may improve diarrhea approximately one day earlier. This study was registered with PROSPERO (CRD 42023405559).

04
META-ANALYSIS European journal of clinical nutrition (2000) PMID: 11114681 ↗
The effect of a probiotic milk product on plasma cholesterol: a meta-analysis of short-term intervention studies.
Clinical Trial Synthesis 2000 Meta-Analysis published in European journal of clinical nutrition; statistical significance reported at p = 0.01. Key conclusion: CONCLUSIONS: The present meta-analysis of controlled short-term intervention studies shows that the fermented yoghurt product produced a 4% decrease in total cholesterol and a 5% decrease in LDL-cholesterol when the open-label study is
View Original PubMed Abstract ↓

INTRODUCTION: Certain fermented dairy milk products may have beneficial effects on plasma cholesterol levels. However, a number of studies have produced conflicting results as to whether dietary supplementation by a probiotic dairy product containing the bacteria culture Causido(R) reduces plasma cholesterol. OBJECTIVE: To conduct a meta-analysis of intervention studies to evaluate the effect of the Causido(R) culture on plasma total cholesterol and low-density lipoprotein (LDL)-cholesterol. THE PROBIOTIC MILK PRODUCT: The yoghurt product Gaio(R) is fermented with Causido(R), composed of one strain of Enterococcus faecium (human species) with the proposed cholesterol-lowering effect, and two strains of Streptococcus thermophilus. STUDY INCLUSION AND DATA EXTRACTION: Six studies were identified from a literature search and from the yoghurt producer. All studies met the inclusion criteria. Summary data for plasma concentrations of total cholesterol and LDL-cholesterol were extracted from the original publications or by personal request to the authors. Data from 4-8 weeks of treatment duration was used. STATISTICAL ANALYSIS: We performed a traditional meta-analysis where mean differences between intervention and control of the pre-post changes in total cholesterol and LDL-cholesterol were calculated, as well as 95% confidence intervals (CIs). RESULTS: In the six studies included in the meta-analysis, the Gaio(R) interventions produced changes in total cholesterol above those of the control groups ranging from -0.02 to -1.02 mmol/l and in LDL-cholesterol ranging from -0.02 to -1.15 mmol/l. After inclusion of an open-label study, the meta-analysis of the double-blind studies showed that Gaio(R) as compared to the control group changed total cholesterol by -0.22 mmol/l (95% CI: -0.35 to -0.08, P<0.01) and LDL-cholesterol by -0.20 mmol/l (95% CI: -0.33 to -0.06, P<0.005). The outcome was essentially the same if all studies were included. CONCLUSIONS: The present meta-analysis of controlled short-term intervention studies shows that the fermented yoghurt product produced a 4% decrease in total cholesterol and a 5% decrease in LDL-cholesterol when the open-label study is

05
RANDOMIZED TRIAL (RCT) Journal of gastroenterology and hepatology (2026) PMID: 41249095 ↗
Effect of Probiotics on the Gut Microbiota After Colonoscopy: A Multicenter, Randomized, Placebo-Controlled Clinical Study.
Clinical Trial Synthesis 2026 Randomized Controlled Trial (RCT) published in Journal of gastroenterology and hepatology involving n = 301 participants; statistical significance reported at p = 0.011. Key conclusion: Administering probiotics postcolonoscopy leads to beneficial alterations in gut microbiota and associated metabolic pathways, while abdominal discomfort symptoms were improved early.
View Original PubMed Abstract ↓

BACKGROUND AND AIM: Alterations in gut microbiota after colonoscopy have been observed. Moreover, there is limited consensus regarding the impact of the procedure on gut microbiota. We aim to evaluate whether the probiotic can treat gut microbiota and abdominal symptoms disturbance after colonoscopy. METHODS: A total of 301 participants were randomized into probiotic and placebo groups. The probiotic group received live combined Bacillus Subtilis and Enterococcus Faecium-coated capsules (0.5 g thrice daily for 28 days) postcolonoscopy. The placebo group was given placebo in an identical manner. Fecal samples were collected from participants and symptoms were reported. The intestinal microbiota composition was assessed using 16S rRNA sequencing. RESULTS: Notable differences in α (p = 0.011) and β (p < 0.001) diversity were observed after colonoscopy. Bowel cleansing resulted in the proliferation of Pseudomonas and Klebsiella in the placebo group. However, the probiotic group exhibited a marked enrichment in beneficial probiotics such as Lactobacillales (p = 0.002). Gastrointestinal symptom rating scale (GSRS) showed significant improvements in the probiotic group within the initial week (p = 0.005). Patients in the probiotic group who exhibited symptoms experienced fewer days of abdominal discomfort postcolonoscopy (p = 0.034). Additionally, they exhibited enhanced glucose metabolism (p = 0.040) and a notable increase in Lactobacillales (p = 0.009). In the probiotic group, α and β diversities differed significantly in patients without GSRS improvements, and the concentration of Bacteroides was significantly elevated (p = 0.004). CONCLUSION: Gut microbiota was altered after colonoscopy, especially the proliferation of potentially pathogenic bacteria. Administering probiotics postcolonoscopy leads to beneficial alterations in gut microbiota and associated metabolic pathways, while abdominal discomfort symptoms were improved early. © 2025 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

06
RANDOMIZED TRIAL (RCT) Movement disorders (2025) PMID: 41126787 ↗
Effects of a Four-Strain Probiotic on Gut Microbiota, Inflammation, and Symptoms in Parkinson's Disease: A Randomized Clinical Trial.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Movement disorders involving n = 74 participants; statistical significance reported at p = 0.05. Key conclusion: CONCLUSIONS: This probiotic was effective in beneficially enriching the gut microbiota with potential to reduce systemic inflammation, shortening time-to-on following levodopa administration, and alleviating NMS burden in PwP experiencing constipation.
View Original PubMed Abstract ↓

BACKGROUND: Gut dysbiosis and gut-brain-axis involvement in people with Parkinson's disease (PwP) support the use of gut-microbiota-modulating interventions. Probiotics may help manage constipation in PwP; however, mechanisms underpinning additional beneficial properties are unknown. OBJECTIVE: The aim was evaluating the effects of a probiotic (Lacticaseibacillus rhamnosus, Lactobacillus acidophilus, Lactiplantibacillus plantarum and Enterococcus faecium) on gut microbiota, inflammation, motor and non-motor symptoms (NMS) in PwP and constipation. METHODS: In this multicenter, randomized, double-blind, placebo-controlled trial (NCT05146921), PwP and constipation were randomized (1:1) to receive either the probiotic (4.08 × 108 CFU/mL) or placebo orally (70 mL/day) for 12 weeks. The primary endpoint was the differential abundance of gut microbiota taxa between baseline and end-of-treatment in the active versus placebo group. Secondary/exploratory endpoints included changes in inflammatory cytokines plasma levels, short-chain fatty acids (SCFAs) plasma and fecal levels, motor and NMS outcomes after 12 weeks. A per-protocol analysis was performed. RESULTS: Between July 17, 2019 and February 6, 2022, 74 participants were randomized. Data from 35 (probiotic) and 33 (placebo) participants were analyzed. Enrichments of bacteria with beneficial health-related properties (Odoribacteraceae, Enterococcaceae, and Blautia faecicola) were observed in the active group compared to placebo (P ≤ 0.05). Proinflammatory cytokine TNF-α plasma levels decreased with probiotic treatment and increased with placebo (P < 0.05). No changes in SCFAs levels were observed. Reductions in time-to-on and NMS scale scores (P < 0.05) were observed only in the active group. CONCLUSIONS: This probiotic was effective in beneficially enriching the gut microbiota with potential to reduce systemic inflammation, shortening time-to-on following levodopa administration, and alleviating NMS burden in PwP experiencing constipation. © 2025 The Author(s). Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society. © 2025 The Author(s). Movement Disor

07
RANDOMIZED TRIAL (RCT) Scientific reports (2025) PMID: 40890215 ↗
Impact of Enterococcus faecium 129 BIO 3B-R on Helicobacter pylori eradication therapy side effects in adult patients: a randomized, double-blind, placebo-controlled study.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Scientific reports. Key conclusion: However, in a post-hoc age-stratified analysis, participants aged 70 and older who used Enterococcus faecium 129 BIO 3B-R experienced tended to have more diarrhea during the eradication period but subsequently experienced significantly less diarrhea after eradication compared to
View Original PubMed Abstract ↓

Managing the side effects of diarrhea, which is associated with intestinal microbial dysbiosis, is a crucial challenge in Helicobacter pylori eradication therapy. The aim of this study is to explore whether administration of a probiotic strain Enterococcus faecium 129 BIO 3B-R, a multi-antibiotic resistant lactic acid bacterium, influences the side effects of Helicobacter pylori eradication therapy in adults. Seventy-six adults undergoing this therapy were randomized to receive either Enterococcus faecium 129 BIO 3B-R or a placebo in a double-blind manner. No significant difference was observed in the incidence of diarrhea, the primary endpoint, or in any other secondary endpoints, including intestinal microbiota diversity, between two groups in the overall study population. However, in a post-hoc age-stratified analysis, participants aged 70 and older who used Enterococcus faecium 129 BIO 3B-R experienced tended to have more diarrhea during the eradication period but subsequently experienced significantly less diarrhea after eradication compared to the control group (23.1% vs. 60%). Treatment with Enterococcus faecium 129 BIO 3B-R also maintained higher α-diversity in their intestinal microbiota than those in the placebo group. Those data suggest that the administration of Enterococcus faecium 129 BIO 3B-R could potentially alleviate diarrhea and intestinal dysbiosis in over 70-year-old elderly patients undergoing Helicobacter pylori eradication. © 2025. The Author(s).

08
RANDOMIZED TRIAL (RCT) Nutricion hospitalaria (2025) PMID: 40066582 ↗
Effects of probiotic supplementation on blood lipids ın hypercholesterolemic obese patients: a randomized, double-blind, placebo-controlled pilot trial.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Nutricion hospitalaria involving n = 12 participants; statistical significance reported at p = 0.05. Key conclusion: These results indicate that anthropometric indices significantly decreased in response to adherence to the low-calorie diet recommended by dietitians in both the groups.
View Original PubMed Abstract ↓

Objective: this trial aimed to determine the effects of probiotic supplementation on weight loss and lipid profiles in hypercholesterolemic obese patients. Methods: ın this pilot randomized, double-blind, placebo-controlled trial, hypercholesterolemic obese patients (BMI = 30.0-35.0 kg/m2) were randomly divided into 2 groups to receive either probiotic capsules (n = 12) or a matching placebo (n = 12) groups. The patients in the probiotic group took capsules 2 times a day that contained Enterococcus faecium, Lactobacillus plantarum, Streptococcus thermophiles, Bifidobacterium lactis, Lactobacillus acidophilus, Bifidobacterium longum (1.5 × 109 CFU/g) for 8 weeks. All patients adhered to a medical nutrition therapy that aimed for a weight loss of 0.5 to 1 kg per week. Anthropometric measurements and body composition were taken at baseline and were monitored every week throughout the study. Blood lipids were assessed at baseline and after the 8-week intervention. Results: after the 8-week dietary intervention, both probiotic and placebo groups showed significant decreased in total cholesterol (-36.50 ± 19.27 vs -25.91 ± 19.25, mg/dl), LDL-C (-(31.75 ± 18.11 vs -31.91 ± 31.00 mg/dl) and TG (-31.83 ± 67.37 vs -28.25 ± 59.09), respectively (p < 0.05). Body weight, BMI, body fat ratio, and waist circumference also significantly decreased after the dietary intervention in both groups (p < 0.05). Overall, no significant difference was found neither in the reductions of total cholesterol, LDL-C, TG concentrations nor the anthropometric indices between the probiotic and placebo groups (p > 0.05). Conclusions: the results of our study demonstrated that the administration of probiotic supplements for 8 weeks in obese subjects with hypercholesterolemia had favorable effects on lipid profiles, although there was no beneficial effect compared to the control group. These results indicate that anthropometric indices significantly decreased in response to adherence to the low-calorie diet recommended by dietitians in both the groups. However, conducting more trails with large sample size and longer follow-up time is necessary. Publisher: Objetivo: este ensayo tuvo como objetivo d

09
RANDOMIZED TRIAL (RCT) Nutrients (2024) PMID: 39599756 ↗
Probiotic Therapy of Gastrointestinal Symptoms During COVID-19 Infection: A Randomized, Double-Blind, Placebo-Controlled, Remote Study.
Clinical Trial Synthesis 2024 Randomized Controlled Trial (RCT) published in Nutrients involving n = 30 participants; statistical significance reported at p = 0.002. Key conclusion: CONCLUSIONS: Patients with mild COVID-19 disease in home quarantine exhibited respiratory symptoms, a reduced gastrointestinal quality of life, and changes in the fecal microbiome and metabolome.
View Original PubMed Abstract ↓

BACKGROUND: The novel coronavirus (SARS-CoV-2) led to gastrointestinal manifestations in up to 50% of cases, with diarrhea being common, and probiotics have been suggested as a potential treatment. AIM: This study aimed to assess changes in the microbiome and the effects of a multispecies probiotic in patients with COVID-19 in home quarantine through a fully remote telemedical approach. METHODS: Thirty patients were randomized to receive either the Ecologic AAD probiotic (Winclove Probiotics, Amsterdam, The Netherlands), on the market as OMNi-BiOTiC 10 (Allergosan, Austria), or a placebo for 30 days in a 2:1 ratio. Respiratory and gastrointestinal symptoms were monitored in 2-10-day intervals via online surveys, and five stool samples were collected during the 30-day study period for microbiome and metabolomics analyses. Twenty-four healthy volunteers served as controls. RESULTS: Of the 30 patients, 26 completed this study (10 placebo, 16 probiotic). Patients reported respiratory symptoms and a diminished gastrointestinal quality of life, both of which improved significantly during the study period, irrespective of the intervention. Compared to controls, infected patients showed significant alterations in the fecal microbiome (p = 0.002), including an increase in Bacteroidetes and decreases in Christensenellaceae, Ruminococcaceae, and Gammaproteobacteria, along with metabolomic changes. Probiotic treatment significantly modulated the patients' microbiome beta diversity (p = 0.001) and introduced the Enterococcus faecium W54 strain. Symptoms, COVID-19-related taxa, and the fecal metabolome were not affected by the intervention. CONCLUSIONS: Patients with mild COVID-19 disease in home quarantine exhibited respiratory symptoms, a reduced gastrointestinal quality of life, and changes in the fecal microbiome and metabolome.

10
CLINICAL STUDY Nutrients (2024) PMID: 39458493 ↗
Initial Study on the Impact of Probiotics on Postoperative Gastrointestinal Symptoms and Gut Microbiota after Sleeve Gastrectomy: A Placebo-Controlled Study.
Clinical Trial Synthesis 2024 Clinical Study published in Nutrients; statistical significance reported at p = 0.027. Key conclusion: CONCLUSIONS: Probiotic supplementation after SG significantly reduces constipation without adverse effects.
View Original PubMed Abstract ↓

BACKGROUND: Sleeve gastrectomy (SG) has become the predominant bariatric surgery, leading to significant weight loss and reductions in obesity-related complications. However, postoperative gastrointestinal symptoms such as constipation and bloating are common. This study aims to evaluate the impact of probiotic supplementation on postoperative gastrointestinal symptoms in patients undergoing SG. The secondary aim is to analyze laboratory and stool test results. MATERIALS AND METHODS: This prospective, placebo-controlled study included patients undergoing SG at a single center. Participants were adults without specific gastrointestinal diseases. They were randomly assigned to either the Probiotics or Controls group. Gastrointestinal symptoms and laboratory and stool tests were assessed before surgery and one month after. RESULTS: Thirty-one patients participated, with 15 in the Probiotics group and 16 in the Controls group. Probiotic supplementation significantly increased the number of stools per week (p = 0.027) and reduced constipation incidence (p = 0.002). Patients in the Probiotics group reported easier defecation and greater bowel movement completeness (p = 0.015, p = 0.004). No significant differences in weight loss or laboratory tests were observed between the groups. Stool microbiota analysis showed a return to normal levels of Enterococcus faecalis, Enterococcus faecium, and Clostridium perfringens in the Probiotics group and an increase in the Controls group. CONCLUSIONS: Probiotic supplementation after SG significantly reduces constipation without adverse effects. These findings suggest that incorporating probiotics into postoperative care protocols can enhance patient comfort and recovery.

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