NICEVIVA
MONOGRAPH SPEC LATEST 2026

Faecalibacterium prausnitzii

PROBIOTICS · Evidence Monograph

Faecalibacterium prausnitzii is an evidence-graded probiotics monograph evaluated across 22 peer-reviewed PubMed studies (2 meta-analyses, 7 systematic reviews, and 6 randomized controlled trials, encompassing n = 7,593 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 22 Studies
Meta-Analyses · Reviews 2 Meta · 7 Systematic Reviews
Randomized Trials (RCT) 6 RCTs (6 Double-Blind)
Cumulative Participants n = 7,593
Reported Trial Dosages 6 g/day · 18 g/day · 22 g/day
Trial Duration Range 12 weeks · 8 weeks · 90 days
Reading Time ~11 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 22 indexed PubMed studies, GRADE High).
  2. 02 Adults matching clinical trial dosing protocols (6 g/day · 18 g/day · 22 g/day) over a structured 12 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
cancer (PubMed clinical endpoint)
immune (PubMed clinical endpoint)
muscle (PubMed clinical endpoint)
gut (PubMed clinical endpoint)
01

What Is Faecalibacterium prausnitzii & Why Does Form Matter?

Faecalibacterium prausnitzii is classified under PROBIOTICS and has been investigated across 22 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 (6 g/day, 18 g/day, 22 g/day).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Faecalibacterium prausnitzii 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 (6 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Faecalibacterium prausnitzii 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 Faecalibacterium prausnitzii an overall evidence rating of GRADE High (4.0 / 4.0) based on 22 PubMed studies: 2 meta-analyses, 7 systematic reviews, and 6 randomized controlled trials (6 double-blind, n = 7,593 total participants).

Representative peer-reviewed findings include: • PMID:41196286 (2026) — "The impact of gut microbiota modulation on responses to immune checkpoint inhibitors in cancer." (Collectively, gut microbiota composition and its modulation significantly impact the therapeutic efficacy and toxicity profile of ICIs.) • PMID:28179092 (2017) — "Altered molecular signature of intestinal microbiota in irritable bowel syndrome patients compared with healthy controls: A systematic review and meta-analysis." (CONCLUSION: Down-regulation of bacterial colonization including Lactobacillus, Bifidobacterium and F.) • PMID:41470885 (2025) — "Bioconversion-Based Postbiotics Enhance Muscle Strength and Modulate Gut Microbiota in Healthy Individuals: A Randomized, Double-Blind, Placebo-Controlled Trial." (CONCLUSIONS: KP supplementation produced a modest within-group improvement in grip strength, potentially through gut-muscle axis modulation involving irisin and anti-inflammation pathways.)

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)OR Effect Size & 95% CI DistributionEstimate (95% CI)PMID 411962862.91 (0.51–0.76)PMID 406294035.790.2Null (1)5Metric: OR
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 6 g/day · 18 g/day · 22 g/day · 20.7 g/day over 12 weeks · 8 weeks · 90 days · 28 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 Faecalibacterium prausnitzii, 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 (6 g/day · 18 g/day · 22 g/day) and re-evaluate efficacy after 12 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 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 (22 Studies) · 12 Quantitative Analyses

01
CLINICAL STUDY Acta microbiologica et immunologica Hungarica (2026) PMID: 41196286 ↗
The impact of gut microbiota modulation on responses to immune checkpoint inhibitors in cancer.
Clinical Trial Synthesis 2026 Clinical Study published in Acta microbiologica et immunologica Hungarica involving n = 5,642 participants (OR 2.91). Key conclusion: Collectively, gut microbiota composition and its modulation significantly impact the therapeutic efficacy and toxicity profile of ICIs.
View Original PubMed Abstract ↓

The gut microbiota has emerged as a critical determinant of antitumor immunity and a potential modulator of responses to immune checkpoint inhibitors (ICIs). Although pre-clinical and clinical studies suggest that specific bacterial taxa may influence both efficacy and immune-related adverse events (irAEs). However, the magnitude and consistency of these associations remain unclear. A systematic search of PubMed, Embase, Web of Science, and the Cochrane Library was conducted through March 2025. Eligible studies evaluated baseline gut microbiota composition, fecal microbiota transplantation (FMT), probiotic/prebiotic interventions, or antibiotic exposure in cancer patients treated with ICIs. Pooled hazard ratios (HRs) for overall survival (OS) and progression-free survival (PFS), and odds ratios (ORs) for response rates and irAEs, were estimated using random-effects models. Across 38 studies involving 5,642 patients were included. Pooled analysis demonstrated that enrichment of Akkermansia muciniphila, Bifidobacterium longum and Faecalibacterium prausnitzii was significantly associated with improved OS (HR 0.62, 95% CI 0.51-0.76) and PFS (HR 0.69, 95% CI 0.55-0.83). Conversely, antibiotic exposure before or during ICI treatment was associated with worse OS (HR 1.84, 95% CI 1.45-2.34). Patients undergoing FMT from responders exhibited higher objective response rates (OR 2.91, 95% CI 1.48-5.73). Microbiota diversity indices were consistently higher in responders than in non-responders. Collectively, gut microbiota composition and its modulation significantly impact the therapeutic efficacy and toxicity profile of ICIs. These findings highlight the translational potential of microbiome-based biomarkers and interventions in optimizing immunotherapy.

02
META-ANALYSIS Digestive and liver disease (2017) PMID: 28179092 ↗
Altered molecular signature of intestinal microbiota in irritable bowel syndrome patients compared with healthy controls: A systematic review and meta-analysis.
Clinical Trial Synthesis 2017 Meta-Analysis published in Digestive and liver disease; statistical significance reported at p = 0.001 (SMD -0.85). Key conclusion: CONCLUSION: Down-regulation of bacterial colonization including Lactobacillus, Bifidobacterium and F.
View Original PubMed Abstract ↓

BACKGROUND: Many studies have reported significant changes in intestinal microbiota in irritable bowel syndrome (IBS) patients based on quantitative real-time PCR analysis. AIMS: We aimed to review the alterations in intestinal microbiota. METHODS: An online search up to June 9, 2016, was conducted. This systematic review and meta-analysis included differential expression of intestinal microbiota in patients with IBS versus healthy controls (HCs) and subgroup analysis. We assessed the quality of the included studies using an original assessment tool. RESULTS: A total of 13 articles involving 360 IBS patients and 268 healthy controls were included. The quality assessment scores for these articles ranged from 5 to 8. Significant differences in expression in IBS patients were observed for Lactobacillus (SMD=-0.85, P<0.001, I2=28%), Bifidobacterium (SMD=-1.17, P<0.001, I2=79.3%), and Faecalibacterium prausnitzii (SMD=-1.05, P<0.001, I2=0.0%) but not Bacteroides-Prevotella group, Escherichia coli or other genera or species. Subgroup analysis showed that diarrhea-predominant IBS patients had significantly different expression of Lactobacillus (SMD=-1.81, P<0.001) and Bifidobacterium (SMD=-1.45, P<0.001). CONCLUSION: Down-regulation of bacterial colonization including Lactobacillus, Bifidobacterium and F. prausnitzii was observed in IBS patients, particularly in diarrhea-predominant IBS (IBS-D). Microbiota changes participate in the pathogenesis of IBS and may underlie the efficacy of probiotic supplements.

03
RANDOMIZED TRIAL (RCT) Nutrients (2025) PMID: 41470885 ↗
Bioconversion-Based Postbiotics Enhance Muscle Strength and Modulate Gut Microbiota in Healthy Individuals: A Randomized, Double-Blind, Placebo-Controlled Trial.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Nutrients. Key conclusion: CONCLUSIONS: KP supplementation produced a modest within-group improvement in grip strength, potentially through gut-muscle axis modulation involving irisin and anti-inflammation pathways.
View Original PubMed Abstract ↓

BACKGROUND: Postbiotics produced by kefir lactic acid bacteria through bioconversion of polyphenol-rich extract and whey protein are emerging as promising modulators of gut microbiota and muscle health. This study investigated whether Lentilactobacillus kefiri DH5-derived postbiotics, prepared with Cucumis melo L. and whey protein (KP, Kefir lactic acid bacteria-derived postbiotics), improve muscle strength and gut microbiota composition in healthy adults. METHODS: In this 12-week, randomized, double-blind, placebo-controlled trial, participants consumed either KP (6 g/day) or placebo. Handgrip strength, circulating biomarkers, and fecal microbiota profiling (using 16S rRNA sequencing) were analyzed. Correlations between microbial taxa and muscle-related biomarkers were assessed. RESULTS: KP supplementation significantly increased dominant-hand grip strength and plasma irisin and reduced IL-1β concentrations after 12 weeks, whereas IGF-1, lean mass, and non-dominant grip strength showed no significant changes. Gut microbiota profiling revealed enrichment of Bifidobacterium adolescentis, Latilactobacillus sakei, Lentihominibacter hominis, Mediterraneibacter gnavus, Streptococcus anginosus and Phocaeicola plebeius, with concomitant reductions in Lachnospira eligens, Roseburia inulinivorans, Ruthenibacterium lactatiformans and Vescimonas fastidiosa. Notably, relative abundance of Faecalibacterium prausnitzii was positively correlated with plasma irisin concentration. CONCLUSIONS: KP supplementation produced a modest within-group improvement in grip strength, potentially through gut-muscle axis modulation involving irisin and anti-inflammation pathways. These preliminary findings suggest that kefir-derived postbiotics may have potential relevance for muscle health.

04
CLINICAL STUDY MicrobiologyOpen (2025) PMID: 41133990 ↗
The Effects of the Crohn's Disease Exclusion Diet (CDED) Alone Versus CDED Plus Partial Enteral Nutrition (PEN) on Gut Microbiome Composition in Pediatric CD Patients.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in MicrobiologyOpen involving n = 60 participants; statistical significance reported at p = 0.001. Key conclusion: Changes in Clostridium leptum and Ruminococcus were minimal and not statistically significant between or within groups.
View Original PubMed Abstract ↓

Crohn's disease (CD) is a chronic inflammatory bowel condition characterized by relapsing inflammation and microbial dysbiosis. Diet-based therapies have emerged as promising adjuncts in pediatric CD management. To our knowledge, this is the first randomized trial to directly compare Crohn's Disease Exclusion Diet (CDED) with and without Partial Enteral Nutrition (PEN) in pediatric Crohn's patients from a microbiome perspective, highlighting the potential clinical relevance of dietary strategies that are more feasible than exclusive enteral nutrition. In this randomized controlled trial, 60 children with mild-to-moderate CD were assigned to either a CDED-only group or a CDED + PEN group. Gut microbiota composition was assessed using quantitative PCR before and after the 8-week intervention. After 8 weeks, both groups exhibited significant increases in Faecalibacterium prausnitzii, with the CDED + PEN group demonstrating a significantly greater increase compared to the CDED group alone (+8.94 vs. +5.00 log CFU, p < 0.001). In the CDED + PEN group, levels of Bifidobacterium and Lactobacillus also rose significantly, whereas in the CDED-only group, Bifidobacterium slightly decreased and Lactobacillus showed only a modest increase. Moreover, a significant reductions in Escherichia coli and Fusobacterium were observed in the CDED + PEN group compared to CDED alone (E. coli, -1.44 log CFU, p < 0.001; Fusobacterium, -1.08 log CFU, p < 0.001). Changes in Clostridium leptum and Ruminococcus were minimal and not statistically significant between or within groups. These findings suggest a synergistic effect of CDED when combined with PEN in modulating the gut microbiome toward a more anti-inflammatory profile. These findings suggest that CDED + PEN may enhance microbiome modulation compared to CDED alone; however, given the modest sample size and 8-week follow-up, these results should be interpreted cautiously. © 2025 The Author(s). MicrobiologyOpen published by John Wiley & Sons Ltd.

05
CLINICAL STUDY Carbohydrate polymers (2025) PMID: 40973277 ↗
Multi-omics analysis of a prebiotic intervention with pectin in lipid transfer proteins (LTPs) allergic patients.
Clinical Trial Synthesis 2025 Clinical Study published in Carbohydrate polymers. Key conclusion: Reduced concentrations of branched SCFAs were observed after both treatments compared to Placebo.
View Original PubMed Abstract ↓

Currently, there is great interest in the use of pectins for prebiotic treatment of food allergy. Hence, the effects of two different esterified pectins - low methoxyl citrus-derived pectin (CP-DElow) and high methoxyl apple-derived pectin (AP-DEhigh) - were evaluated in peach allergic patients due to sensitization to lipid transfer proteins (LTPs). This study analyzed the systemic immune response, the gut microbiota composition (using 16S rRNA gene sequencing), and microbial-derived metabolome, including short-chain fatty acids (SCFAs) and bile acids (BAs). Prebiotic treatment with both pectins was safe and induced a significant clinical increase in allergen tolerance in more than 50 % of patients. Additionally, CP-DElow and AP-DEhigh groups exhibited a distinctive systemic proteomic profile characterized by a decrease in various inflammatory cytokines compared to Placebo. Regarding microbiota, CP-DElow induced an increase in Bacteroides_H genus and Roseburia intestinalis species, whereas AP-DEhigh was associated with an increase in Bifidobacterium and Succinivibrio genera, and Faecalibacterium prausnitzii species. Reduced concentrations of branched SCFAs were observed after both treatments compared to Placebo. Likewise, fecal levels of microbial-derived secondary BAs were modified by pectin supplementation. Multi-omics integration revealed distinctive signatures in pectin- and placebo-treated patients. This study suggests that pectin treatment is a promising and safe option for LTP allergy.

06
RANDOMIZED TRIAL (RCT) The American journal of clinical nutrition (2025) PMID: 40946805 ↗
Magnesium treatment increases gut microbiome synthesizing vitamin D and inhibiting colorectal cancer: results from a double-blind precision-based randomized placebo-controlled trial.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in The American journal of clinical nutrition involving n = 112 participants; statistical significance reported at p = 0.001. Key conclusion: CONCLUSIONS: In individuals with adequate TRPM7 function, Mg supplementation increases the abundance of C.
View Original PubMed Abstract ↓

BACKGROUND: Carnobacterium maltaromaticum and Faecalibacterium prausnitzii induce de novo gut synthesis of vitamin D to inhibit colorectal carcinogenesis in mice. Magnesium (Mg) treatment increases circulating vitamin D, and Mg homeostasis is dependent on TRPM7 genotype. OBJECTIVES: We hypothesize that Mg treatment increases gut C. maltaromaticum and F. prausnitzii, and the effect differs by TRPM7 polymorphism. METHODS: The Personalized Prevention of Colorectal Cancer Trial is a double-blind, precision-based randomized controlled trial with 240 participants randomly assigned to both treatment and TRPM7 genotype. Stool, rectal swabs, and rectal mucosa were collected. RESULTS: Of 239 participants who completed the trial, 226 with valid microbiome data were analyzed (treatment n = 112, placebo n = 114). The interaction between treatment and TRPM7 genotype was only significant for C. maltaromaticum (P = 0.001) and F. prausnitzii (P = 0.02) in rectal swabs. In a stratified analysis by TRPM7 genotype without the missense variant, Mg treatment compared with placebo significantly increased abundance of C. maltaromaticum (0.217 ± 0.615 (23.01%) compared with -0.065 ± 0.588 (-6.30%); P = 0.006) and F. prausnitzii (0.105 ± 0.817 (2.13%) compared with -0.095 ± 0.856 (-1.92%); P = 0.04) in rectal swabs. The effect on C. maltaromaticum remained after multiple comparisons (Q = 0.05 for C. maltaromaticum across all sample types and genotypes). In those with the TRPM7 missense variant, Mg decreased C. maltaromaticum, but not F. prausnitzii, compared with placebo in rectal swabs [-0.065 ± 0.511 (-6.54%) compared with 0.133 ± 0.503 (13.30%); adjusted P = 0.04]. The effect did not remain after false discovery rate correction. Mg treatment's effect on C. maltaromaticum in rectal swabs primarily appeared in females, and the treatment-genotype interaction remained significant. CONCLUSIONS: In individuals with adequate TRPM7 function, Mg supplementation increases the abundance of C. maltaromaticum and F. prausnitzii. CLINICAL TRIAL REGISTRY: This trial was registered at clinicaltrials.gov as NCT04229992 (https://clinicaltrials.gov/study/NCT04229992?term=NCT04229992&rank=1). The parent

07
CLINICAL STUDY Clinical nutrition ESPEN (2025) PMID: 40127766 ↗
Effects of defatted rice bran-fortified bread on gut microbiome, cardiovascular risk, gut discomfort, wellbeing and gut physiology in healthy adults with low dietary fibre intake.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Clinical nutrition ESPEN involving n = 15 participants; statistical significance reported at p = 0.001. Key conclusion: No significant differences were observed in the primary outcome, microbial taxa composite within and between groups (False Discovery Rate (FDR) correction, p > 0.10).
View Original PubMed Abstract ↓

BACKGROUND & AIMS: Inadequate dietary fibre (DF) intake is associated with suboptimal gut function and increased risk of several human diseases. Bread is commonly consumed and is ideal to incorporate cereal bran to increase DF content. No human studies have investigated the effects of defatted rice bran (DRB) in bread, which has triple the DF of white bread, purported hypo-allergenicity and a unique nutrient profile, as a dietary intervention in healthy adults. This study aims to assess the relative abundances of a composite of key faecal microbial genera and species involved in DF fermentation and metabolism following the habitual intake of DRB-fortified bread and its influence on other biological markers of host and microbial interactions, cardiovascular risk profile, patient-reported outcomes, total DF intake, and gut physiology in healthy adults with low baseline DF intake. METHODS: Fifty-six healthy adults with low baseline DF intake (<18 g/day (females), <22 g/day (males)) completed a two-arm, placebo-controlled, double-blind, randomised, crossover study. Participants consumed three (females) or four (males) slices of DRB-fortified bread or control bread daily as part of their usual diet for four weeks, with the intervention periods separated by a two-week washout. Outcomes included faecal microbiota composite (primary outcome); relative abundances (taxa and gene); faecal moisture content and bile acid concentrations; plasma and faecal organic acid concentrations; cardiovascular risk profile; gut comfort, psychological wellbeing parameters; total DF intake; whole gut transit time, and were measured at baseline and following each intervention phase. Additionally, in a sub-study, 15 participants ingested gas-sensing capsules to assess whole and regional gut transit times, and total and regional colonic hydrogen and carbon dioxide concentrations at the same timepoints. RESULTS: DRB-fortified bread consumption significantly increased total DF intake from 20.7 g/day to 43.4 g/day (p < 0.001). No significant differences were observed in the primary outcome, microbial taxa composite within and between groups (False Discovery Rate (FDR) correction, p > 0.10). As c

08
CLINICAL STUDY Molecular nutrition & food research (2025) PMID: 39981988 ↗
Nutraceutical Blends Promote Weight Loss, Inflammation Reduction, and Better Sleep: The Role of Faecalibacterium prausnitzii in Overweight Adults-A Double-Blind Trial.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Molecular nutrition & food research involving n = 77 participants. Key conclusion: The nutraceutical blend reshaped gut microbiota, enhanced anti-inflammatory species, and improved metabolic and sleep parameters, highlighting its potential as a nutritional strategy for managing obesity and reducing inflammation.
View Original PubMed Abstract ↓

This study explores the effects of a nutraceutical blend with prebiotics, β-glucans, essential minerals, and silymarin on gut microbiota, inflammation, and sleep quality in obesity through microbiota reshaping and metabolic improvements over 90 days. A double-blind, randomized trial was conducted on 77 participants divided into two groups receiving either a standard nutraceutical blend (NSupple) or a silymarin-enriched blend (NSupple_Silybum). Fecal and plasma samples were collected at baseline and post-supplementation for gut microbiota, metabolic, and inflammatory marker analysis. The results showed a reduction in body weight, waist-to-height ratio, total cholesterol, and fractions in the NSupple_Silybum group. There was a dysbiosis recovery shown by the increase in beneficial gut bacteria, such as Lentisphaerae phylum, Lactobacillus and Faecalibacterium genera, and Faecalibacterium prausnitzii in the NSupple group, with a concurrent reduction in Adlercreutzia and Sutterella in the NSupple_Silybum group. Both groups demonstrated improved inflammatory profiles by the reduced TNF-α/IL-10 ratio, reduced cortisol levels, and reduced Firmicutes/Bacteroides ratio. Additionally, improvements in sleep quality were associated with reductions in pro-inflammatory cytokines and improved microbiota composition. The nutraceutical blend reshaped gut microbiota, enhanced anti-inflammatory species, and improved metabolic and sleep parameters, highlighting its potential as a nutritional strategy for managing obesity and reducing inflammation. © 2025 The Author(s). Molecular Nutrition & Food Research published by Wiley‐VCH GmbH.

09
RANDOMIZED TRIAL (RCT) Nutrients (2025) PMID: 39940370 ↗
Effects of Kefir Consumption on Gut Microbiota and Athletic Performance in Professional Female Soccer Players: A Randomized Controlled Trial.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Nutrients. Key conclusion: CONCLUSIONS: This study indicated that kefir consumption can positively affect the gut microbiota, which could in turn affect the athletes' performance.
View Original PubMed Abstract ↓

BACKGROUND/OBJECTIVES: This study aimed to determine the impact of the daily consumption of kefir on the gut microbiome, body composition, and athletic performance of professional female soccer players. METHODS: The participants encompassed 21 females aged 18-29 years who were assigned to one of the two groups: the experimental group, which comprised females who consumed 200 mL of kefir daily for 28 days, and the control group, which comprised females who continued with their normal diet. Anthropometric measurements, dietary intake, the composition of the gut microbiome through 16S rRNA gene sequencing, and an athletic performance test known as the 30-15 Intermittent Fitness Test were performed before and after the intervention. RESULTS: The results of this study revealed that the consumption of kefir increased the microbial diversity (Shannon and Chao1 indices), wherein a significant increase was noted in the abundance of Akkermansia muciniphila and Faecalibacterium prausnitzii, microorganisms that regulate energy metabolism and have anti-inflammatory effects. Furthermore, the athletic performance variables, including VO2max (mL.kg-1.min-1) and finishing speed (km/h), were strongly related to the abundance of these short-chain fatty acid-producing bacteria. A link between the microbiota profile and the dietary intake of fiber and protein as well as the body composition measurements was also established. CONCLUSIONS: This study indicated that kefir consumption can positively affect the gut microbiota, which could in turn affect the athletes' performance. Therefore, to determine the effects of kefir as a functional food in sports nutrition over a longer period, more research should be conducted.

10
RANDOMIZED TRIAL (RCT) Food & function (2025) PMID: 39641169 ↗
Impact of daily avocado consumption on gut microbiota in adults with abdominal obesity: an ancillary study of HAT, a randomized controlled trial.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Food & function involving n = 230 participants. Key conclusion: Conclusions: Our findings document a potentially favorable effect of avocados on gut microbiota diversity.
View Original PubMed Abstract ↓

Objectives: This study aimed to investigate short-term and long-term impact of avocado consumption without caloric restriction on the gut microbiota of free-living adults with abdominal obesity. Methods: The Habitual Diet and Avocado Trial (HAT) was a 26-week, multi-center, randomized, controlled trial involving 1008 individuals with abdominal obesity. Participants were randomly assigned to the Avocado Supplemented Diet Group (AVO), receiving one avocado per day, or the Habitual Diet group (HAB), maintaining their usual dietary habits. Fecal samples were collected at baseline, week 4 and week 26 from a subset of participants recruited at a University of California Los Angeles site (n = 230). Fecal microbiota was assessed with shotgun metagenomics sequencing. Alpha diversity was assessed using the Chao1 and Shannon indices; beta diversity was assessed using Bray-Curtis dissimilarity with significance determined by repeated measures permutational multivariat analysis of variance. Potential association of intervention at week 4 and 26 with alpha diversity, species and metabolic pathways was examined using linear mixed effect models. Results: Compared to the HAB group, the AVO group had higher alpha diversity by 4 weeks, which persisted through the 26-week study period. Exploratory analysis based on healthy eating index-2015 (HEI-2015) indicated that participants with a low HEI score at baseline (≤52.7), had an increase in alpha diversity in the AVO group vs. HAB group. The AVO group had a significant change in beta diversity at week 26 compared to the HAB group. At the species level, the AVO group had significantly increased Faecalibacterium prausnitzii and Bacterium AF16_15 at week 26 compared to the HAB group. Functional analysis showed no significant difference in metabolic pathways between the HAB and AVO groups. Conclusions: Our findings document a potentially favorable effect of avocados on gut microbiota diversity. The prebiotic potential of avocados is more pronounced in individuals with a low diet quality score. This trial is registered at clinicaltrials.gov as NCT03528031 (https://clinicaltrials.gov/study/NCT03528031).

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