RecruitingNot ApplicableNCT07369830

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


Sponsor

Huashan Hospital

Enrollment

156 participants

Start Date

Oct 15, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether taking a probiotic (a beneficial bacteria supplement) after rectal cancer surgery helps improve gut health and bowel function once a temporary bowel diversion bag (stoma) is reversed. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with very low rectal cancer and had a sphincter-saving surgery (intersphincteric resection) - You have a temporary stoma (bowel diversion bag) that is planned to be reversed within 6 months - You are willing and able to provide informed consent **You may NOT be eligible if...** - You had radiation therapy before your surgery - You have experienced serious complications after surgery (such as an anastomotic leak) - You need to take antibiotics for more than 3 months - You are allergic to the probiotic used in this study (Clostridium butyricum) - You have inflammatory bowel disease, a neurological disorder, or a major psychiatric condition - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALClostridium 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


Locations(1)

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07369830


Related Trials