NCT07369830

The Impact of Probiotic Intervention on the Gut Microbiota and Bowel Function

The Impact of Probiotic Intervention on the Gut Microbiota and Bowel Function of Patients With Prophylactic Ileostomy for Ultra Low Rectal Cancer -a Multicenter Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to propose a novel, easy-to-operate intervention strategy that effectively improves defecation function after stoma reversal and to assess its impact on the gut microbiota.The efficacy and safety of antegrade placement of probiotics into the distal deserted intestine during prophylactic stoma to improve bowel function after stoma reversal were evaluated through randomized controlled clinical trials.Observing the changes in gut microbiota during the prophylactic stoma period, the impact of probiotics on the structure of gut microbiota, and exploring the correlation between gut genera and bowel function after stoma reversal.

Detailed description

This study includes patients with ultra low rectal cancer who underwent ISR（Intersphincteric Resection） and prophylactic ileostomy. Patients are randomly assigned to the low dose group,high dose group and the control group in a 1:1:1 ratio. The low dose group received interventions (4 Meiya pills, administered into the dysfunctional intestine once a week) starting 1 week after the ileostomy, the high dose group received interventions (4 Meiya pills, administered into the dysfunctional intestine twice a week) starting 1 week after the ileostomy, while the control group received routine postoperative follow-up. Evaluation indicators included bowel function and quality of life before the prophylactic ileostomy and 1 week, 2 weeks, 1 month, 3 months, and 6 months and so on until two years after the stoma reversal. Fecal samples are collected prior to prophylactic ileostomy. Post-stoma reversal surgery, fecal samples are obtained from patients at their first defecation . All fecal samples underwent 16s rRNA gene sequencing and bioinformatic analysis to compare the microbial composition differences among three groups. Key genera associated with bowel function were identified through correlation analysis.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Clostridium butyricum (live) Tablets(Meiya)	Clostridium butyricum (live) Tablet administered into the dysfunctional intestine for low dose and high dose group, while control group has no intervention

Timeline

• Start date: 2025-10-15
• Primary completion: 2029-03-30
• Completion: 2029-06-30
• First posted: 2026-01-27
• Last updated: 2026-01-27

Locations

1 site across 1 country: China