Evidence map›Paper›PMID 42017290›Full record

Trial reportDiabetes, obesity & metabolism2026

Bifidobacterium bifidum G9-1 Intake Improves Gastrointestinal Symptoms in Type 2 Diabetes Mellitus: An Open-Label, Randomized Controlled Trial (Binary STAR Study).

Genki Kobayashi, Yoshitaka Hashimoto, Tomoyuki Matsuyama, Noriyuki Kitagawa, Saori Majima, Takafumi Senmaru, Emi Ushigome, Hiroshi Okada, Naoko Nakanishi, Masahide Hamaguchi and 1 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

11 authors.

Genki KobayashiDepartment of Internal Medicine, Makino Hospital, Takashima, Shiga, Japan.ORCID 0009-0001-6154-682X
Yoshitaka HashimotoDepartment of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Kyoto, Japan.
Tomoyuki MatsuyamaDepartment of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Kyoto, Japan.
Noriyuki KitagawaDepartment of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Kyoto, Japan.ORCID 0000-0003-3263-9469
Saori MajimaDepartment of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Kyoto, Japan.
Takafumi SenmaruDepartment of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Kyoto, Japan.
Emi UshigomeDepartment of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Kyoto, Japan.ORCID 0000-0003-1031-4380
Hiroshi OkadaDepartment of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Kyoto, Japan.ORCID 0000-0002-1707-970X
Naoko NakanishiDepartment of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Kyoto, Japan.
Masahide HamaguchiDepartment of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Kyoto, Japan.ORCID 0000-0002-8651-4445
Michiaki FukuiDepartment of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Kyoto, Japan.

Funding

the Biofermin Pharmaceutical Co. Ltd.
6 · The paper itself

Abstract

aimsTo evaluate the effects of probiotics Bifidobacterium bifidum G9-1 (BBG9-1) on gastrointestinal symptoms in patients with Type 2 diabetes mellitus (T2DM) with diarrhoea or constipation. MATERIALS AND

methodsIn a 12-week open-label randomised controlled trial, 100 participants were randomized 1:1 to a control or BBG9-1 group, with 12 mg of Bifidobacterium administered daily. The primary endpoint was the change in total Gastrointestinal Symptom Rating Scale (GSRS) score (range: 1-7) in the full analysis set (BBG9-1: n = 43; control: n = 51).

resultsBBG9-1 intake significantly improved the GSRS total score (from 2.22 ± 0.67 to 1.83 ± 0.62) compared with control (from 2.08 ± 0.67 to 2.06 ± 0.63; between-group difference, -0.34 [95% CI: -0.55 to -0.14; p = 0.001]). Subgroup analyses indicated greater GSRS total score improvement in women, participants with constipation, aged ≥ 65 years, and BMI < 25 kg/m

conclusionsBBG9-1 administration significantly improved gastrointestinal symptoms in patients with T2DM.

trial registrationJapan Registry of Clinical Trials (jRCTs051220127).

Indexed as

Bifidobacterium bifidumConstipationDiabetes Mellitus, Type 2DiarrheaProbioticsAgedFemaleHumansMaleMiddle AgedTreatment OutcomeBifidobacterium bifidum G9‐1constipationdiarrhoeagastrointestinal symptomsgut microbiotaType 2 diabetes

Identifiers

PMID42017290
PMCPMC13243959

What OpenQuestion holds

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Registered trials

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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 OpenQuestion graph.