Evidence map›Paper›PMID 41852479›Full record

Trial reportFrontiers in endocrinology2026

Multi-strain probiotic reduces gastrointestinal side effects in women with elevated HOMA-IR index treated with metformin: a 12-week randomised controlled trial.

Marzena Ratajczak, Agnieszka Bilska, Katarzyna Musialik, Karolina Skonieczna-Żydecka, Igor Łoniewski, Anna Gogojewicz, Joanna Karolkiewicz

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Frontiers in endocrinology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06092060 (The Effect of a Multi-strain Probiotic Consisting of), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06092060 nacompletednot on this map

The Effect of a Multi-strain Probiotic Consisting of: Bifidobacterium Lactis W52, Lactobacillus Brevis W63, Lactobacillus Casei W56, Lactococcus Lactis W19, Lactococcus Lactis W58, Lactobacillus Acidophilus W37, Bifidobacterium Bifidum W23, Bifidobacterium Lactis W51, and Lactobacillus Salivarius W24 on Metformin Tolerance and Efficacy With Microbiota and Stool Metabolome in Insulin-resistant Women - a 12-week Randomized, Placebo-controlled, Double-blind Study

TypeinterventionalSponsorPoznan University of Physical EducationRan2021 to 2023Enrolled40ConditionsInsulin ResistanceArmsthe group GS (probiotic), the group GP (placebo)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Marzena RatajczakDepartment of Medical Biology, Poznan University of Physical Education, Poznan, Poland.
Agnieszka BilskaDepartment of Food and Nutrition, Poznan University of Physical Education, Poznan, Poland.
Katarzyna MusialikDepartment of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznan University of Medical Sciences, Poznan, Poland.
Karolina Skonieczna-ŻydeckaDepartment of Biochemical Research, Pomeranian Medical University, Szczecin, Poland.
Igor ŁoniewskiDepartment of Biochemical Research, Pomeranian Medical University, Szczecin, Poland.
Anna GogojewiczDepartment of Food and Nutrition, Poznan University of Physical Education, Poznan, Poland.
Joanna KarolkiewiczDepartment of Food and Nutrition, Poznan University of Physical Education, Poznan, Poland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Metformin is widely used as a first-line therapy for type 2 diabetes and increasingly prescribed off-label in women with elevated HOMA-IR indices, including those at risk of metabolic disorders. However, its clinical use is often limited by gastrointestinal (GI) adverse effects. The present study examined whether a multi-strain probiotic could enhance the metabolic effects of metformin and reduce GI side effects in women with newly identified elevated HOMA-IR. Methods: In this 12-week randomised, placebo-controlled, double-blind trial, 30 women aged 25-45 years with elevated HOMA-IR (≥2.5) and no diagnosis of diabetes were enrolled. All participants were prescribed metformin 1000 mg/day. They were randomised 1:1 to receive either a multi-strain probiotic (2 × 10 Results: After 12 weeks, the probiotic group reported significantly fewer GI symptoms compared with placebo, including lower frequency of abnormal stool consistency during abdominal pain (26% vs. 52%, p < 0.05), abnormal stool frequency (18% vs. 51%, p < 0.05), and hard or lumpy stools (Bristol types 1-2; 14% vs. 26%, p < 0.05). No significant between-group differences were observed for metabolic or anthropometric parameters. Both groups showed significant improvements over time in fasting glucose (time effect p < 0.05), HOMA-IR (p < 0.05), RBP4 (p < 0.05), and total cholesterol (p < 0.01), with no significant group × time interactions, indicating effects attributable to metformin rather than probiotic supplementation. Conclusion: Multi-strain probiotic supplementation did not enhance the metabolic efficacy of metformin in women with elevated HOMA-IR but significantly alleviated GI side effects. Probiotic co-administration may therefore improve tolerability and adherence to metformin therapy. Clinical trial registration: https://clinicaltrials.gov/study/NCT06092060, identifier NCT06092060.

Indexed as

Diabetes Mellitus, Type 2Gastrointestinal DiseasesHypoglycemic AgentsInsulin ResistanceMetforminProbioticsAdultBlood GlucoseDouble-Blind MethodFemaleHumansMiddle AgedBlood GlucoseHypoglycemic AgentsMetformingastrointestinal side effectsHOMA-IRmetforminprobioticsrandomised controlled trial

Identifiers

PMID41852479
PMCPMC12991998

What Socratic holds

Texttitle and abstract
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.