The Impact of Probiotic Intervention on the Gut Microbiota and Bowel Function
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
| Condition(s) | Rectal Cancer |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. Age between 18 and 75 years 2. Ultra low rectal cancer meeting the indication for Intersphincteric Resection (ISR) surgery 3. Underwent a prophylactic ileostomy 4. Scheduled for stoma reversal surgery within 6 months after the ISR procedure 5. Digestive tract reconstruction achieved via either hand-sewn or stapled coloanal anastomosis 6. Patient has a strong preference for undergoing sphincter-preserving surgery 7. Capable of understanding and willing to provide signed informed consent Exclusion Criteria: 1. Does not meet the surgical indications for Intersphincteric Resection (ISR) 2. Presence of multiple primary colorectal malignancies 3. Patients who have received neoadjuvant radiotherapy 4. Patients who experience disease progression or death in the postoperative |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Huashan Hospital |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2025-10-15 |
| NCT ID | NCT07369830 |
| Official listing | https://clinicaltrials.gov/study/NCT07369830 |