Trial reportJournal of diabetes investigation2022
Effects of probiotic Bifidobacterium bifidum G9-1 on the gastrointestinal symptoms of patients with type 2 diabetes mellitus treated with metformin: An open-label, single-arm, exploratory research trial.
Trial report in Journal of diabetes investigation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07403929 (Determination of the Effect of Fermented Grape Juice Consumption on Oxidative Stress and Inflammation Biomarkers and SIRT-1 Levels in Fibromyalgia Patients), which is not on this map. Cited by 18 papers, 2 of them syntheses that pooled 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.
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.
Determination of the Effect of Fermented Grape Juice Consumption on Oxidative Stress and Inflammation Biomarkers and SIRT-1 Levels in Fibromyalgia Patients
Who cites it
18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 23 citations in OpenAlex.
- Pooled it
- The Effects of Oral Probiotics on Type 2 Diabetes Mellitus (T2DM): A Clinical Trial Systematic Literature Review.Nutrients · 2023Pooled it
- Bifidobacterium bifidum G9-1 Intake Improves Gastrointestinal Symptoms in Type 2 Diabetes Mellitus: An Open-Label, Randomized Controlled Trial (Binary STAR Study).Diabetes, obesity & metabolism · 2026Trial
- Efficacy of probiotics (Bifidobacterium bifidum G9-1) in patients with type 2 diabetes mellitus and chronic kidney disease complicated by constipation: An exploratory, multicenter, open-label, single-arm study (BIRDIE study).Journal of diabetes investigation · 2026Trial
- Effects of probiotic Bifidobacterium bifidum G9-1 on the gastrointestinal symptoms of patients with type 2 diabetes mellitus treated with metformin: An open-label, single-arm, exploratory research trial.Journal of diabetes investigation · 2022 · on this mapTrial
- Article
- Pharmacomicrobiomics in metabolic syndrome and type 2 diabetes: the microbiome-drug-host triad.Frontiers in pharmacology · 2026Review
- Targeting the gut microbiome for type 2 diabetes management: a scoping review of systematic reviews and meta-analyses.Frontiers in endocrinology · 2026Article
- Drugs Versus Microbiota: How Pharmacotherapy Affects Gut and Probiotic Bacteria.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Effects of Italian Mediterranean Organic Diet on the Gut Microbiota: A Pilot Comparative Study with Conventional Products and Free Diet.Microorganisms · 2025Article
- Efficacy of probiotics combined with metformin and a calorie-restricted diet in obese patients with polycystic ovary syndrome.Pakistan journal of medical sciences · 2025Article
- Multi-omics analysis reveals the efficacy of two probiotic strains in managing feline chronic kidney disease through gut microbiome and host metabolome.Frontiers in veterinary science · 2025Article
- Microbiota and enteric nervous system crosstalk in diabetic gastroenteropathy: bridging mechanistic insights to microbiome-based therapies.Frontiers in cellular and infection microbiology · 2025Review
- Metformin-Associated Gastrointestinal Adverse Events Are Reduced by Probiotics: A Meta-Analysis.Pharmaceuticals (Basel, Switzerland) · 2024Article
- Article
- The Influence of Gut Microbial Species on Diabetes Mellitus.International journal of molecular sciences · 2023Review
- Article
- The ProbioticFrontiers in nutrition · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 1 institution in 1 country.
Funding
Abstract
AIMS/
introductionMetformin is associated with the risk of gastrointestinal complications, and probiotic Bifidobacterium bifidum G9-1 (BBG9-1) can improve the symptoms of diarrhea. This study aimed to clarify the effects of probiotic BBG9-1 on the gastrointestinal symptoms of type 2 diabetes mellitus patients using metformin. MATERIALS AND
methodsIn this open-label single-arm exploratory study, 40 patients (mean age 64.0 ± 9.4 years) were given probiotic BBG9-1 for 10 weeks. Changes in the gastrointestinal symptom rating scale total score, which was the primary end-point, gastrointestinal symptom rating scale subscale scores, glycated hemoglobin levels and gut microbiota after the administration of probiotic BBG9-1 were evaluated by the Student's t-test.
resultsThe gastrointestinal symptom rating scale total score significantly improved (from 2.02 ± 0.51 to 1.59 ± 0.43, change, -0.43 ± 0.49, P < 0.001). Furthermore, all gastrointestinal symptom rating scale subscale scores, including diarrhea (from 2.32 ± 1.14 to 1.89 ± 0.99, change, -0.42 ± 0.95, P = 0.007) and constipation (from 3.00 ± 1.16 to 2.20 ± 1.07, change, -0.80 ± 1.19, P < 0.001), scores also significantly improved. However, the glycated hemoglobin levels did not change (from 7.0 ± 0.7 to 7.0 ± 0.6%, change, 0.0 ± 0.4, P = 0.91). The relative abundance of the genus Sutterella decreased by the use of probiotic BBG9-1 (from 0.011 ± 0.009 to 0.008 ± 0.006, change, -0.003 ± 0.006, P = 0.002).
conclusionsType 2 diabetes mellitus patients treated with metformin showed significant improvement in all gastrointestinal symptom rating scores after using probiotic BBG9-1 without changing the glucose control. This study showed the potential usefulness of probiotic BBG9-1 for improving gastrointestinal symptoms, including constipation and diarrhea, in type 2 diabetes mellitus patients treated with metformin.
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What Socratic holds
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.