Evidence map›Paper›PMID 41504339›Full record

Trial reportJournal of diabetes investigation2026

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).

Fuki Ikeda, Junko Sato, Hidenori Yoshii, Masahiro Sugawara, Hiroaki Satoh, Yukiko Sugawara, Hirotsugu Uzawa, Daisuke Sugimoto, Reina Muto, Yuya Nishida and 1 more

Abstract readMulticenter StudyClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of diabetes investigation, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

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

2 citing papers in PubMed.

  1. Trial
  2. Article
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.

Fuki IkedaDepartment of Metabolism and Endocrinology, Graduate School of Medicine, Juntendo University, Tokyo, Japan.
Junko SatoDepartment of Metabolism and Endocrinology, Graduate School of Medicine, Juntendo University, Tokyo, Japan.
Hidenori YoshiiDepartment of Medicine, Diabetology and Endocrinology, Juntendo Tokyo Koto Geriatric Medical Center, Tokyo, Japan.
Masahiro SugawaraSugawara Clinic, Tokyo, Japan.
Hiroaki SatohDepartment of Diabetes and Endocrinology, Urayasu Hospital, Juntendo University, Chiba, Japan.
Yukiko SugawaraDepartment of Metabolism and Endocrinology, Graduate School of Medicine, Juntendo University, Tokyo, Japan.
Hirotsugu UzawaDepartment of Metabolism and Endocrinology, Graduate School of Medicine, Juntendo University, Tokyo, Japan.
Daisuke SugimotoDepartment of Medicine, Diabetology and Endocrinology, Juntendo Tokyo Koto Geriatric Medical Center, Tokyo, Japan.
Reina MutoDepartment of Medicine, Diabetology and Endocrinology, Juntendo Tokyo Koto Geriatric Medical Center, Tokyo, Japan.
Yuya NishidaDepartment of Metabolism and Endocrinology, Graduate School of Medicine, Juntendo University, Tokyo, Japan.
Hirotaka WatadaDepartment of Metabolism and Endocrinology, Graduate School of Medicine, Juntendo University, Tokyo, Japan.

Funding

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

Abstract

introductionAlthough constipation is a major complication of type 2 diabetes mellitus and chronic kidney disease, evidence for its treatment in these patients remains limited. This study aimed to evaluate the therapeutic efficacy of Bifidobacterium bifidum for constipation in these patients. MATERIALS AND

methodsIn this multicenter, open-label, single-arm trial, 30 patients with type 2 diabetes mellitus and chronic kidney disease complicated by constipation were administered Bifidobacterium bifidum G9-1 for 12 weeks. The primary endpoint was the proportion of patients with normal stool form (Bristol Scale score ≥3.5 to <4.5). Secondary endpoints included stool form, defecation frequency, and quality of life.

resultsThe proportion of patients with normal stool form at week 12 (44.8%; 13 patients) was significantly higher than that at baseline (3.3%; 1 patient; P = 0.002). The median Bristol score significantly increased from baseline by 0.6 at week 6 (P < 0.001) and 0.5 at week 12 (P < 0.001). Defecation frequency significantly increased by 0.2 ± 0.4 from baseline to week 6 (P = 0.026). The total constipation, abdominal pain, and indigestion scores on the Gastrointestinal Symptom Rating Scale significantly decreased. Abdominal symptoms, including straining, feelings of incomplete evacuation, bloating, and discomfort, significantly decreased. Glycated hemoglobin and the estimated glomerular filtration rate did not change significantly, whereas urinary albumin levels significantly decreased at week 6. DISCUSSION: Bifidobacterium bifidum improved stool form, defecation frequency, and quality of life of patients with type 2 diabetes mellitus and chronic kidney disease complicated by constipation, without worsening glycemic control and renal function.

Indexed as

Bifidobacterium bifidumConstipationDiabetes Mellitus, Type 2ProbioticsRenal Insufficiency, ChronicAgedFemaleHumansMaleMiddle AgedQuality of LifeTreatment OutcomeConstipationDiabetic nephropathiesProbiotics

Identifiers

PMID41504339
PMCPMC12950917

What Socratic 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 Socratic graph.