Probiotics to improve bowel function after ileostomy reversal for ultra‑low rectal cancer
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
This trial tests whether placing a probiotic (Clostridium butyricum) into the diverted distal bowel before stoma reversal helps people who had intersphincteric resection and a temporary ileostomy recover better bowel function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Huashan Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07369830 on ClinicalTrials.gov |
What this trial studies
Patients who had ultra‑low rectal cancer treated with intersphincteric resection and a protective ileostomy are randomized 1:1:1 to a low‑dose probiotic group (once weekly), a high‑dose group (twice weekly), or routine follow‑up control starting one week after ileostomy. The probiotic (Meiya, live Clostridium butyricum tablets) is delivered antegrade into the distal deserted intestine during the prophylactic stoma period. Bowel function and quality of life are measured before ileostomy and at multiple timepoints up to two years after stoma reversal. Fecal samples are collected pre‑ileostomy and at first defecation after reversal for 16S rRNA sequencing to compare microbiota changes and correlate genera with bowel outcomes.
Who should consider this trial
Good fit: Adults 18–75 years with ultra‑low rectal cancer who underwent intersphincteric resection with a protective ileostomy and are scheduled for stoma reversal within six months are ideal candidates.
Not a fit: Patients who received neoadjuvant radiotherapy, have multiple primary colorectal cancers, severe anastomotic complications, disease progression, or whose stoma reversal is delayed beyond six months are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could reduce post‑reversal bowel dysfunction and improve continence and quality of life after sphincter‑preserving surgery.
How similar studies have performed: Probiotics such as C. butyricum have shown benefit in other gastrointestinal conditions, but antegrade delivery into the diverted distal bowel around stoma reversal is a novel approach with limited randomized data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 period 5. Patients who develop severe anastomotic complications postoperatively, such as anastomotic leakage or stenosis 6. Patients whose actual stoma reversal surgery occurs more than 6 months after the ISR procedure 7. Patients who require long-term(more than 3 months) use of antibiotics 8. History of allergy to Clostridium butyricum (live) Tablets (MIYA) or any of its components 9. Concurrent use of other probiotic during the study period 10. Coexisting inflammatory bowel disease 11. 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) 12. Pregnant or lactating women
Where this trial is running
Shanghai, Shanghai Municipality
- Huashan Hospital Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Xiang Jianbin, Doctor — Huashan Hospital
- Study coordinator: LI Zhenyang, Doctor
- Email: 13764030915@163.com
- Phone: +86-13764030915
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.