Tokyo, May 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061547) titled 'A Study to Evaluate the Effects of Bifidobacterium longum BB536 on Malodorous Flatus and Bowel Dysfunction After Gastrectomy' on May 15.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Kindai University

Condition: Condition - post-gastrectomy syndrome Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim of this study is to evaluate the efficacy of probiotic (Bifidobacterium longum BB536) intake in improving bowel symptoms associated with post-gastrectomy syndrome, particularly malodorous flatus and bowel dysfunction, in patients who have undergone gastrectomy for gastric cancer, including distal gastrectomy, total gastrectomy, and proximal gastrectomy. In addition, this study aims to investigate the sustainability of symptom improvement following BB536 intake. Furthermore, differences in gut microbiota composition before and after BB536 administration, as well as according to the presence or absence of symptoms, will be analyzed. The association between bowel symptoms and alterations in gut microbiota will also be evaluated. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants with a score of 4-7 on questionnaire item 5 (see Section 6.4.4, Assessment Items) will be defined as having flatus-related symptoms, whereas those with a score of 1-3 will be defined as not having flatus-related symptoms. Participants with flatus-related symptoms will be randomly assigned to either the BB536 intervention group or the non-intervention group in a randomized controlled trial.

BB536 intervention group: Participants will orally receive one sachet per day of freeze-dried Bifidobacterium longum BB536 powder (50 billion CFU per 2 g sachet) for 4 weeks. Adherence will be monitored using a medication calendar. After 4 weeks of oral intake, the questionnaire survey and stool sample collection will be repeated. Interventions/Control_2 - Non-intervention group: No intervention will be performed, and participants will undergo a 4-week observation period. After the 4-week observation period, the questionnaire survey and stool sample collection will be repeated.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Participants aged 18 years or older, regardless of sex Participants who underwent gastrectomy at our department, including distal gastrectomy, proximal gastrectomy, or total gastrectomy, and for whom at least 8 weeks have elapsed since surgery Participants who received an explanation of the study and provided written informed consent based on their own free will and sufficient understanding of the study procedures Key exclusion criteria - Participants with a history of antibiotic treatment within 4 weeks prior to the initiation of oral BB536 intake Participants who routinely use medications for constipation (including osmotic laxatives, stimulant laxatives, bulk-forming laxatives, and epithelial function-modifying agents), antidiarrheal agents, or probiotic preparations Participants who routinely consume health foods or supplements containing lactic acid bacteria, bifidobacteria, oligosaccharides, dietary fiber, or similar products Participants who routinely use digestive enzyme supplements Participants with a known allergy to Bifidobacterium longum Participants who expressed unwillingness to participate in this study Participants judged by the principal investigator to be unsuitable for participation in this study for any other reason Target Size - 99

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 02 Month 19 Day Date of IRB - 2026 Year 03 Month 05 Day Anticipated trial start date - 2026 Year 04 Month 20 Day Last follow-up date - 2027 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070314

Disclaimer: Curated by HT Syndication.