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MONOGRAPH SPEC LATEST 2026

Lactobacillus helveticus

PROBIOTICS · Evidence Monograph

Lactobacillus helveticus is an evidence-graded probiotics monograph evaluated across 34 peer-reviewed PubMed studies (0 meta-analyses, 0 systematic reviews, and 13 randomized controlled trials, encompassing n = 31,733 cumulative participants). Current clinical evidence is rated GRADE Moderate (3.0 / 4.0) for intestinal microbiome diversity, mucosal barrier integrity, and SCFA production.

Evidence Grade (GRADE) Moderate (3.0 / 4.0)
Indexed PubMed Studies 34 Studies
Meta-Analyses · Reviews 0 Meta · 0 Systematic Reviews
Randomized Trials (RCT) 13 RCTs (11 Double-Blind)
Cumulative Participants n = 31,733
Reported Trial Dosages 190 g/day · 5 mg · 1.25 mg
Trial Duration Range 8 weeks · 60 days · 6 weeks
Reading Time ~17 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 34 indexed PubMed studies, GRADE Moderate).
  2. 02 Adults matching clinical trial dosing protocols (190 g/day · 5 mg · 1.25 mg) over a structured 8 weeks 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
weight (PubMed clinical endpoint)
liver (PubMed clinical endpoint)
depression (PubMed clinical endpoint)
01

What Is Lactobacillus helveticus & Why Does Form Matter?

Lactobacillus helveticus is classified under PROBIOTICS and has been investigated across 34 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 (190 g/day, 5 mg, 1.25 mg).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Lactobacillus helveticus 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 (13 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Lactobacillus helveticus 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 helveticus an overall evidence rating of GRADE Moderate (3.0 / 4.0) based on 34 PubMed studies: 0 meta-analyses, 0 systematic reviews, and 13 randomized controlled trials (11 double-blind, n = 31,733 total participants).

Representative peer-reviewed findings include: • PMID:41254712 (2025) — "Effects of supplementation with two probiotic strains (Lactobacillus helveticus and Bifidobacterium longum) on hormonal status, oxidative stress, and clinical symptoms in women with polycystic ovary syndrome: a randomized clinical trial." (In conclusion, these findings suggest that 8 weeks of probiotic supplementation may alleviate oxidative stress, modulate certain hormonal factors, and reduce inflammation in women with PCOS.) • PMID:40565286 (2025) — "A Randomized Controlled Trial Evaluating the Effects of a Probiotic Containing Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 on Gastrointestinal Symptoms and Metabolomic Profiles in Female Dancers." (longum R0175 may alter the gut metabolome, notably (2RS)-2-(4-hydroxyphenyl)propionic acid, but small sample size and absent symptom improvement limit the conclusions.) • PMID:39920878 (2025) — "The effect of probiotic-fortified kefir on depression, appetite, oxidative stress, and inflammatory parameters in Iranian overweight and obese elderly: a randomized, double-blind, placebo-controlled clinical trial." (However, when comparing the two groups, no significant effects were observed on appetite, inflammation, and oxidative stress parameters, except for TAC.)

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 190 g/day · 5 mg · 1.25 mg · 44.5 μg over 8 weeks · 60 days · 6 weeks · 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 (190 g/day · 5 mg · 1.25 mg) and re-evaluate efficacy after 8 weeks.
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 (34 Studies) · 14 Quantitative Analyses

01
RANDOMIZED TRIAL (RCT) Nutrition journal (2025) PMID: 41254712 ↗
Effects of supplementation with two probiotic strains (Lactobacillus helveticus and Bifidobacterium longum) on hormonal status, oxidative stress, and clinical symptoms in women with polycystic ovary syndrome: a randomized clinical trial.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Nutrition journal involving n = 90 participants; statistical significance reported at p = 0.001. Key conclusion: In conclusion, these findings suggest that 8 weeks of probiotic supplementation may alleviate oxidative stress, modulate certain hormonal factors, and reduce inflammation in women with PCOS.
View Original PubMed Abstract ↓

Polycystic ovary syndrome (PCOS) is a common endocrine disorder affecting women. This study investigates the impact of 8-week supplementation with two probiotic strains, Lactobacillus helveticus and Bifidobacterium longum, on hormonal status, oxidative stress, and clinical symptoms in women with PCOS. Conducted as a double-blind, placebo-controlled, randomized clinical trial, the research involved 90 women with PCOS from Shahid Beheshti Hospital, Isfahan, Iran. Serum markers were assessed before and after the intervention. After adjusting for baseline values and confounding variables, the 8-week supplementation with two probiotic strains resulted in a significant increase in sex hormone binding globulin (24.39; 95% CI (15.23,33.55) vs. -11.99; 95% CI (-20.12, -3.86) nmol/L, P < 0.001), total antioxidant capacity (125.53; 95% CI (53.78,197.28) vs. -42.90; 95% CI (-78.32, -7.48) nmol/mL, P = 0.002) and Superoxide dismutase activity (0.19; 95% CI (0.09,0.30) vs. -0.11; 95% CI (-0.18, -0.04) U/mL, P < 0.001), in the intervention group compared to the placebo. While free androgen index (-57.05; 95% CI (-80.33, -33.76) vs. 49.86; 95% CI (28.81,70.92), P < 0.001), C-reactive protein (-0.50; 95% CI (-0.95, -0.04) vs. 0.05; 95% CI (-0.39,0.50), P = 0.046), and malondialdehyde levels (- 23.69; 95% CI (-30.02, -17.35) vs. -2.70; 95% CI (-9.19,3.77), P < 0.001), significantly decreased in the intervention group compared to the placebo. Furthermore, testosterone total levels showed a decreasing trend in the intervention group, although the between-group changes were not statistically significant after baseline value and other confounders adjustment (-3.37; 95% CI (-11.85, 5.11) vs. 6.48; 95% CI (3.43, 9.53) ng/dL, P = 0.08). Regarding clinical symptoms, including acne, alopecia, and hirsutism, the between-group changes were insignificant (P > 0.05). In conclusion, these findings suggest that 8 weeks of probiotic supplementation may alleviate oxidative stress, modulate certain hormonal factors, and reduce inflammation in women with PCOS. Trial registration, the current study was registered in the Iranian Registry of Clinical Trials on 30 March 2024 (ID: IRCT20121216011763N62)

02
RANDOMIZED TRIAL (RCT) International journal of molecular sciences (2025) PMID: 40565286 ↗
A Randomized Controlled Trial Evaluating the Effects of a Probiotic Containing Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 on Gastrointestinal Symptoms and Metabolomic Profiles in Female Dancers.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in International journal of molecular sciences involving n = 11 participants; statistical significance reported at p = 0.026. Key conclusion: longum R0175 may alter the gut metabolome, notably (2RS)-2-(4-hydroxyphenyl)propionic acid, but small sample size and absent symptom improvement limit the conclusions.
View Original PubMed Abstract ↓

Dancers experience physical and psychological stressors that can impact gut health. We hypothesized that a three-month supplementation with Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 would result in measurable alterations in the fecal metabolomic profile and improve gastrointestinal symptomatology in dancers. Of the 51 volunteers, 26 female dancers were randomized to a 12-week trial (NCT05567653). A homogenous group of 16 (probiotic: n = 5; placebo: n = 11) was analyzed. The participants received L. helveticus R0052 and B. longum R0175 (3 × 109 colony-forming units/day) or a placebo. Baseline dietary intake and body composition were recorded. Fecal samples were analyzed using liquid chromatography-mass spectrometry, and gastrointestinal symptoms were assessed with the Rome IV questionnaire. Statistical methods included principal component analysis, mixed-effects models, and analysis of variance-simultaneous component analysis (ASCA). The study revealed shifts in the probiotic group's fecal metabolome (permutation test p = 0.026), including a reduction in (2RS)-2-(4-hydroxyphenyl)propionic acid (p = 0.023). No improvement in gastrointestinal symptoms was observed. No adverse events occurred. L. helveticus R0052 and B. longum R0175 may alter the gut metabolome, notably (2RS)-2-(4-hydroxyphenyl)propionic acid, but small sample size and absent symptom improvement limit the conclusions. Larger studies with varied doses and blood metabolite analysis are needed to confirm relevance.

03
RANDOMIZED TRIAL (RCT) Journal of health, population, and nutrition (2025) PMID: 39920878 ↗
The effect of probiotic-fortified kefir on depression, appetite, oxidative stress, and inflammatory parameters in Iranian overweight and obese elderly: a randomized, double-blind, placebo-controlled clinical trial.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Journal of health, population, and nutrition involving n = 35 participants; statistical significance reported at p = 0.001. Key conclusion: However, when comparing the two groups, no significant effects were observed on appetite, inflammation, and oxidative stress parameters, except for TAC.
View Original PubMed Abstract ↓

BACKGROUND: It has been shown that the microflora of the gastrointestinal tract undergoes changes in obese individuals. The present study aimed to investigate the effect of kefir fortified with two strains, Lactobacillus helveticus and Bifidobacterium longum, on depression, appetite, oxidative stress, and inflammatory parameters in overweight and obese elderly individuals. METHODS: This study was a double-blind, randomized, and placebo-controlled clinical trial conducted on 67 elderly men aged over 65, who were randomly divided into two groups. One group (n = 35) received one bottle (240 cc) of regular kefir as a placebo, while the intervention group (n = 32) received one bottle of probiotic-fortified kefir for eight weeks. Depression and appetite were evaluated using the Geriatric Depression Scale-15 (GDS-15) and a validated Visual Analogue Scale (VAS), respectively. Oxidative stress parameters were assessed using the standard calorimetric method, and inflammatory parameters were measured via the enzyme-linked immunosorbent assay method (ELISA). The differences between the two groups were compared using the independent samples T-test. RESULTS: The median age of participant in both groups was 65 years. A significant difference in depression scores and the mean change between the two groups was observed after eight weeks (p = 0.001 and p = 0.042, respectively). Within-group comparison revealed a significant increase in appetite scores in both groups (p < 0.05 for both). Moreover, a significant difference in the changes in total antioxidant capacity (TAC) was noted (p = 0.009). However, no significant differences were observed in other oxidative and inflammatory parameters between the two groups (p˃0.05 for all). CONCLUSIONS: The results demonstrated the positive impact of two specific strains of Bifidobacterium and Lactobacillus on improving depression in the elderly. However, when comparing the two groups, no significant effects were observed on appetite, inflammation, and oxidative stress parameters, except for TAC. © 2025. The Author(s).

04
RANDOMIZED TRIAL (RCT) Nutrients (2024) PMID: 39796535 ↗
Lactobacillus helveticus Induces Two Types of Dendritic Cell Activation and Effectively Suppresses Onset of the Common Cold: A Randomized, Double-Blind, Placebo-Controlled Trial.
Clinical Trial Synthesis 2024 Randomized Controlled Trial (RCT) published in Nutrients. Key conclusion: CONCLUSIONS: These results suggest that GCL1815 intake may enhance the response to viruses by activating two types of dendritic cells, thereby preventing the onset of systemic and local common colds in healthy adults.
View Original PubMed Abstract ↓

BACKGROUND/OBJECTIVES: Lactobacillus helveticus GCL1815 is a lactic acid bacterium thought to activate dendritic cells. This randomized, placebo-controlled, double-blind study aimed to evaluate the effects of L. helveticus GCL1815 on human dendritic cells and the onset of the common cold. METHODS: Two hundred participants were divided into two groups and took capsules containing either six billion L. helveticus GCL1815 cells or placebo for 8 weeks. RESULTS: In the GCL1815 group, the cumulative incidence days of symptoms such as feverishness, fatigue, tiredness, runny nose, nasal congestion, and phlegm were significantly lower than in the placebo group. Moreover, the change in the expression of HLA-DR on plasmacytoid dendritic cells was significantly higher in the GCL1815 group than in the placebo group at 4 and 8 weeks of intake. The expression of CD86 on plasmacytoid dendritic cells was significantly increased in the GCL1815 group at 4 and 8 weeks compared with before intake. Additionally, the expression of HLA-DR on type 1 conventional dendritic cells was significantly higher in the GCL1815 group than in the placebo group at 8 weeks of intake. The expression of CD86 on type 1 conventional dendritic cells significantly decreased in the placebo group but remained statistically the same in the GCL1815 group after intake compared with before. CONCLUSIONS: These results suggest that GCL1815 intake may enhance the response to viruses by activating two types of dendritic cells, thereby preventing the onset of systemic and local common colds in healthy adults.

05
RANDOMIZED TRIAL (RCT) Clinical nutrition ESPEN (2024) PMID: 39089652 ↗
Probiotics may be useful for drug-induced liver dysfunction in patients with depression - A secondary analysis of a randomized clinical trial.
Clinical Trial Synthesis 2024 Randomized Controlled Trial (RCT) published in Clinical nutrition ESPEN involving n = 116 participants; statistical significance reported at p = 0.94. Key conclusion: CONCLUSIONS: Multiple factors may modulate the postulated hepatoprotective properties of probiotics efficacy in patients with depression.
View Original PubMed Abstract ↓

BACKGROUND & AIMS: There is a need to identify new treatment options for depression with its comorbidities. Depression often coexists with liver steatosis and the two may share a pathophysiological overlap, including inflammation and microbiota changes. Probiotics might represent a safe option as an adjunctive therapy in patients with depression and possible liver steatosis. The paper presents the secondary analysis of a clinical trial of the effect of probiotic supplementation on the levels of non-invasive markers of liver steatosis and fibrosis in adult patients with depressive disorders. METHODS: The research had a two-arm, parallel-group, prospective, randomized, double-blind, controlled design on probiotics in depression. 116 participants received a probiotic preparation containing Lactobacillus helveticus Rosell®-52 and Bifidobacterium longum Rosell®-175 over 60 days. Here, data from 92 subjects was analyzed. The following were assessed: alanine aminotransferase (ALT), alanine aminotransferase/aspartate aminotransferase (ALT/AST) ratio, Hepatic Steatosis Index, Framingham Steatosis Index, as well as non-invasive biomarkers of liver fibrosis (AST to Platelet Ratio Index, Fibosis-4 Index), or baseline socio-demographic, clinical, and laboratory parameters. RESULTS: The probiotics did not influence liver steatosis and fibrosis parameters compared with placebo (p = 0.940 for HSI). However, the subgroup analysis revealed significant differences in liver-related parameters when stratified by the main diagnosis group (better improvement in steatosis indices after probiotics in depressive episode than mixed depression and anxiety disorder patients) or psychotropic medications use (better improvement in ALT-based indices after probiotics in antidepressant-treated subjects than those non-antidepressant-treated). The interplay between probiotics, medications, clinical and metabolic profiles of depression, and the changes in liver-related parameters has been discussed. CONCLUSIONS: Multiple factors may modulate the postulated hepatoprotective properties of probiotics efficacy in patients with depression. Further studies with larger sample sizes, different probiotic st

06
RANDOMIZED TRIAL (RCT) Nutrients (2024) PMID: 39064634 ↗
Effects of Heat-Treated Lactobacillus helveticus CP790-Fermented Milk on Gastrointestinal Health in Healthy Adults: A Randomized Double-Blind Placebo-Controlled Trial.
Clinical Trial Synthesis 2024 Randomized Controlled Trial (RCT) published in Nutrients involving n = 60 participants. Key conclusion: These results suggest that the intake of CP790-fermented milk could be effective in modulating gut microbiota and improving constipation symptoms and mood states.
View Original PubMed Abstract ↓

Probiotic-fermented milk is commonly used to maintain intestinal health. However, the effects of heat-treated fermented milk, which does not contain live microorganisms, on intestinal function are not yet fully understood. This study aimed to investigate whether heat-treated Lactobacillus helveticus CP790-fermented milk affects fecal microbiota and gut health as a "postbiotic". A randomized, double-blind, placebo-controlled trial was conducted in healthy Japanese individuals aged 20-59 years with a tendency toward constipation. Participants consumed 100 mL of either the test beverage (n = 60) or placebo beverage (n = 60) for four weeks. The test beverages were prepared with heat-treated CP790-fermented milk, while the placebo beverages were prepared with nonfermented milk flavored with lactic acid. Fecal samples were analyzed using 16S rRNA gene sequencing. Constipation symptoms were assessed using defecation logs and the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire. Mood state was also assessed using the Profile of Mood States 2 (POMS2) questionnaire to explore its potential as a "psychobiotic". Desulfobacterota were significantly decreased by CP790-fermented milk intake. PICRUSt2 analysis predicted a decrease in the proportion of genes involved in the sulfate reduction pathway following the consumption of CP790-fermented milk. The CP790-fermented milk intervention significantly improved stool consistency and straining during defecation. These improvements were correlated with a decrease in Desulfobacterota. After the intervention, overall mood, expressed as total mood disturbance, and depression-dejection were significantly better in the CP790 group than in the placebo group. These results suggest that the intake of CP790-fermented milk could be effective in modulating gut microbiota and improving constipation symptoms and mood states.

07
RANDOMIZED TRIAL (RCT) Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme (2024) PMID: 39018571 ↗
Impact of probiotic supplementation on exercise endurance among nonelite athletes: a randomized, placebo-controlled, double-blind, clinical trial.
Clinical Trial Synthesis 2024 Randomized Controlled Trial (RCT) published in Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme involving n = 14 participants; statistical significance reported at p = 0.01. Key conclusion: Time-to-exhaustion increased in the placebo group, possibly due to differences in training habits.
View Original PubMed Abstract ↓

This randomized, placebo-controlled, double-blind, parallel trial investigated whether generally healthy adult, nonelite runners would have a greater time-to-exhaustion during submaximal treadmill running with probiotic versus placebo supplementation. It was hypothesized that the probiotic would impact training progression by reducing gastrointestinal (GI) and cold/flu symptoms. Participants who typically ran ≥24 km/week, ran or cross-trained 3-5 days per week, and had a maximal oxygen intake (V̇O2 max) in the 60-85th percentile were enrolled. V̇O2 max was used to establish individualized workload settings (85% of V̇O2 max) for the submaximal endurance tests at baseline and following 6 weeks of supplementation with a probiotic (Lactobacillus helveticus Lafti L10, 5×109 CFU/capsule/day) or placebo. Participants self-reported GI and cold/flu symptoms and physical activity via daily and weekly questionnaires. Outcomes were tested using a linear model to determine if mean response values adjusted for baseline differed between groups. Twenty-eight participants (n = 14/group), aged 25 ± 5 years (mean ± SD) with a body mass index of 23 ± 3 kg/m2, completed the study. At the final visit the probiotic group had a lower time-to-exhaustion versus the placebo group (P = 0.01) due to an increase in time-to-exhaustion with the placebo (1344 ± 188 to 1565 ± 219 s, P = 0.01) with no change with the probiotic (1655 ± 230 to 1547 ± 215 s, P = 0.23). During the intervention, the probiotic group completed fewer aerobic training sessions per week (P = 0.02) and trained at a lower intensity (P = 0.007) versus the placebo group. Few GI and cold/flu symptoms were reported with no differences between groups. Time-to-exhaustion increased in the placebo group, possibly due to differences in training habits.

08
RANDOMIZED TRIAL (RCT) International journal of molecular sciences (2024) PMID: 38891799 ↗
Evaluating the Impact of Probiotic Therapy on the Endocannabinoid System, Pain, Sleep and Fatigue: A Randomized, Double-Blind, Placebo-Controlled Trial in Dancers.
Clinical Trial Synthesis 2024 Randomized Controlled Trial (RCT) published in International journal of molecular sciences involving n = 10 participants; statistical significance reported at p = 0.05. Key conclusion: Probiotic supplementation showed no significant impact on CB2 or FAAH levels, pain, or fatigue but suggested potential benefits for sleep quality, suggesting an area for further research.
View Original PubMed Abstract ↓

Emerging research links the endocannabinoid system to gut microbiota, influencing nociception, mood, and immunity, yet the molecular interactions remain unclear. This study focused on the effects of probiotics on ECS markers-cannabinoid receptor type 2 (CB2) and fatty acid amide hydrolase (FAAH)-in dancers, a group selected due to their high exposure to physical and psychological stress. In a double-blind, placebo-controlled trial (ClinicalTrials.gov NCT05567653), 15 dancers were assigned to receive either a 12-week regimen of Lactobacillus helveticus Rosell-52 and Bifidobacterium longum Rosell-17 or a placebo (PLA: n = 10, PRO: n = 5). There were no significant changes in CB2 (probiotic: 0.55 to 0.29 ng/mL; placebo: 0.86 to 0.72 ng/mL) or FAAH levels (probiotic: 5.93 to 6.02 ng/mL; placebo: 6.46 to 6.94 ng/mL; p > 0.05). A trend toward improved sleep quality was observed in the probiotic group, while the placebo group showed a decline (PRO: from 1.4 to 1.0; PLA: from 0.8 to 1.2; p = 0.07841). No other differences were noted in assessed outcomes (pain and fatigue). Probiotic supplementation showed no significant impact on CB2 or FAAH levels, pain, or fatigue but suggested potential benefits for sleep quality, suggesting an area for further research.

09
RANDOMIZED TRIAL (RCT) Nutrients (2024) PMID: 38732635 ↗
Metabolic Status Influences Probiotic Efficacy for Depression-PRO-DEMET Randomized Clinical Trial Results.
Clinical Trial Synthesis 2024 Randomized Controlled Trial (RCT) published in Nutrients involving n = 94 participants; statistical significance reported at p = 0.45. Key conclusion: A higher baseline stress level was correlated with better improvements.
View Original PubMed Abstract ↓

Probiotics may represent a safe and easy-to-use treatment option for depression or its metabolic comorbidities. However, it is not known whether metabolic features can influence the efficacy of probiotics treatments for depression. This trial involved a parallel-group, prospective, randomized, double-blind, controlled design. In total, 116 participants with depression received a probiotic preparation containing Lactobacillus helveticus Rosell®-52 and Bifidobacterium longum Rosell®-175 or placebo over 60 days. The psychometric data were assessed longitudinally at five time-points. Data for blood pressure, body weight, waist circumference, complete blood count, serum levels of C-reactive protein, cholesterol, triglycerides, and fasting glucose were measured at the beginning of the intervention period. There was no advantage of probiotics usage over placebo in the depression score overall (PRO vs. PLC: F(1.92) = 0.58; p = 0.45). However, we found a higher rate of minimum clinically important differences in patients supplemented with probiotics than those allocated to placebo generally (74.5 vs. 53.5%; X2(1,n = 94) = 4.53; p = 0.03; NNT = 4.03), as well as in the antidepressant-treated subgroup. Moreover, we found that the more advanced the pre-intervention metabolic abnormalities (such as overweight, excessive central adipose tissue, and liver steatosis), the lower the improvements in psychometric scores. A higher baseline stress level was correlated with better improvements. The current probiotic formulations may only be used as complementary treatments for depressive disorders. Metabolic abnormalities may require more complex treatments. ClinicalTrials.gov identifier: NCT04756544.

10
RANDOMIZED TRIAL (RCT) BMC women's health (2024) PMID: 38172876 ↗
Synbiotic as an ameliorating factor in the health-related quality of life in women with polycystic ovary syndrome. A randomized, triple-blind, placebo-controlled trial.
Clinical Trial Synthesis 2024 Randomized Controlled Trial (RCT) published in BMC women's health involving n = 28 participants; statistical significance reported at p = 0.044. Key conclusion: CONCLUSION: This study illustrated the advantageous effects of synbiotics on the health-related quality of life in women with PCOS.
View Original PubMed Abstract ↓

BACKGROUND: There are complicated mechanisms that link the disruption of the gut microbiome to the symptoms and complications of polycystic ovary syndrome (PCOS). In this study, an attempt was made to assess the effects of synbiotics on the health-related quality of life (HRQoL) in women with PCOS . METHODS: Fifty-six women with PCOS were enrolled in a triple-blind controlled trial for 12 weeks. They were randomly assigned to receive a daily 2-gram synbiotic sachets (containing Bacillus coagulans (GBI-30), Lactobacillus rhamnosus, Lactobacillus helveticus, and fructooligosaccharide) (n = 28) or placebo (n = 28). To evaluate the impact on the HRQoL, participants were required to fill 26-Item Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ-26), 12-Item Short-Form Health Survey (SF-12) and Perceived Stress Scale (PSS-10) pre and post the intervention. RESULTS: Finally, statistical analyses were performed on 52 participants who finished the trial. Synbiotic supplementation improved the scores of emotional (P = 0.044), body hair (P = 0.016), weight (P = 0.033) and infertility domains (P = 0.027) of PCOSQ-26 compared to placebo group. The physical score within SF-12 also had a significant enhancement (P = 0.035). No significant improvement was seen in the PSS-10 score at the end of the trial. CONCLUSION: This study illustrated the advantageous effects of synbiotics on the health-related quality of life in women with PCOS. Further studies are required to confirm our findings. TRIAL REGISTRATION: http://www.irct.ir : IRCT20211108053007N1; date of registration: 14/02/2023. © 2024. The Author(s).

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