Dataset Information

Protocol of efficacy of bifidobacteria intake on gastrointestinal symptoms in symptomatic type 2 diabetes mellitus patients in abdominis: An open-label, randomized controlled trial (Binary STAR study).

ABSTRACT:

Background

This randomized, parallel-group study aims to investigate the effects of the probiotic Bifidobacterium bifidum G9-1 (BBG9-1) on the symptoms of diarrhea or constipation in patients with type 2 diabetes mellitus (T2DM).

Methods

This study will examine 100 patients with T2DM who suffering from symptoms of diarrhea or constipation. Eligible patients will be randomly assigned 1:1 to two groups (group A, BBG9-1 group; group B, control group), after the baseline examination. Patients assigned to group A will receive probiotic BBG9-1 oral administration along with their current treatment for 12 weeks, and patients assigned to group B will continue the current treatment for 12 weeks without probiotic BBG9-1 oral administration. Subsequently, examinations similar to the baseline examinations will be performed. The primary endpoint will be a change in the Gastrointestinal Symptom Rating Scale (GSRS) total score from baseline to week 12. Secondary endpoints will include the following: change and percent change in parameters such as GSRS subdomain scores, fecal properties/Bristol stool form scale, defecation frequency, biomarkers, gut microbiota, and macronutrients and factors that affect GSRS total score or constipation/diarrhea subdomain scores from baseline to week 12.

Discussion

The results of this study will clarify the utility of probiotic BBG9-1 in the treatment of diarrhea or constipation in patients with T2DM.

Trial registration

jRCTs051220127.

SUBMITTER: Hashimoto Y

PROVIDER: S-EPMC10783735 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Protocol of efficacy of bifidobacteria intake on gastrointestinal symptoms in symptomatic type 2 diabetes mellitus patients in abdominis: An open-label, randomized controlled trial (Binary STAR study).

Hashimoto Yoshitaka Y Kobayashi Genki G Kitagawa Noriyuki N Okada Hiroshi H Hamaguchi Masahide M Fukui Michiaki M

PloS one 20240111 1

<h4>Background</h4>This randomized, parallel-group study aims to investigate the effects of the probiotic Bifidobacterium bifidum G9-1 (BBG9-1) on the symptoms of diarrhea or constipation in patients with type 2 diabetes mellitus (T2DM).<h4>Methods</h4>This study will examine 100 patients with T2DM who suffering from symptoms of diarrhea or constipation. Eligible patients will be randomly assigned 1:1 to two groups (group A, BBG9-1 group; group B, control group), after the baseline examination. ...[more]

PMID: 38206908

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Dataset Information

Protocol of efficacy of bifidobacteria intake on gastrointestinal symptoms in symptomatic type 2 diabetes mellitus patients in abdominis: An open-label, randomized controlled trial (Binary STAR study).

Background

Methods

Discussion

Trial registration

Publications

Protocol of efficacy of bifidobacteria intake on gastrointestinal symptoms in symptomatic type 2 diabetes mellitus patients in abdominis: An open-label, randomized controlled trial (Binary STAR study).

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