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
Huashan Hospital
156 participants
Oct 15, 2025
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
Inclusion Criteria7
- Age between 18 and 75 years
- Ultra low rectal cancer meeting the indication for Intersphincteric Resection (ISR) surgery
- Underwent a prophylactic ileostomy
- Scheduled for stoma reversal surgery within 6 months after the ISR procedure
- Digestive tract reconstruction achieved via either hand-sewn or stapled coloanal anastomosis
- Patient has a strong preference for undergoing sphincter-preserving surgery
- Capable of understanding and willing to provide signed informed consent
Exclusion Criteria12
- Does not meet the surgical indications for Intersphincteric Resection (ISR)
- Presence of multiple primary colorectal malignancies
- Patients who have received neoadjuvant radiotherapy
- Patients who experience disease progression or death in the postoperative period
- Patients who develop severe anastomotic complications postoperatively, such as anastomotic leakage or stenosis
- Patients whose actual stoma reversal surgery occurs more than 6 months after the ISR procedure
- Patients who require long-term(more than 3 months) use of antibiotics
- History of allergy to Clostridium butyricum (live) Tablets (MIYA) or any of its components
- Concurrent use of other probiotic during the study period
- Coexisting inflammatory bowel disease
- History of neurological or psychiatric disorders, including but not limited to Parkinson's disease, Alzheimer's disease, organic brain diseases, stroke, epilepsy, or major psychiatric disorders (e.g., major depressive disorder)
- Pregnant or lactating women
Interventions
Clostridium butyricum (live) Tablet administered into the dysfunctional intestine for low dose and high dose group, while control group has no intervention
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07369830