Actively Recruiting
The Impact of Probiotic Intervention on the Gut Microbiota and Bowel Function
Led by Huashan Hospital · Updated on 2026-01-27
156
Participants Needed
1
Research Sites
193 weeks
Total Duration
On this page
Sponsors
H
Huashan Hospital
Lead Sponsor
C
Characteristic Medical Center of Rocket Army
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Impact of Probiotic Intervention on the Gut Microbiota and Bowel Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Diagnosis of ultra low rectal cancer suitable for Intersphincteric Resection (ISR) surgery
- Underwent prophylactic ileostomy
- Scheduled for stoma reversal surgery within 6 months after ISR
- Digestive tract reconstruction with hand-sewn or stapled coloanal anastomosis
- Strong preference for sphincter-preserving surgery
- Able to understand and provide signed informed consent
You will not qualify if you...
- Not meeting surgical indications for Intersphincteric Resection (ISR)
- Having multiple primary colorectal malignancies
- Received neoadjuvant radiotherapy
- Experienced disease progression or death postoperatively
- Developed severe anastomotic complications such as leakage or stenosis
- Stoma reversal surgery delayed beyond 6 months after ISR
- Require long-term antibiotic use over 3 months
- Allergy to Clostridium butyricum (live) Tablets or any components
- Using other probiotics during the study
- Have inflammatory bowel disease
- History of neurological or psychiatric disorders including Parkinson's, Alzheimer's, stroke, epilepsy, or major psychiatric disorders
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
Research Team
L
LI Zhenyang, Doctor
CONTACT
X
Xiang Jianbin, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here