NCT07369830Recruiting
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
Source: ClinicalTrials.gov · Last updated 27 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 156 (estimated)
- First submitted
- 23 Dec 2025
- Start date
- 15 Oct 2025
- Primary completion date
- 30 Mar 2029
- Lead sponsor
- Huashan Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT07369830
What you commit to
- Study type: Interventional
- Planned participants: 156
- From 15 Oct 2025 to the primary completion date, 30 Mar 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Does not meet the surgical indications for Intersphincteric Resection (ISR)
- Patients who have received neoadjuvant radiotherapy
- Patients whose actual stoma reversal surgery occurs more than 6 months after the ISR procedure
- Concurrent use of other probiotic during the study period
Other illness
- Presence of multiple primary colorectal malignancies
- Patients who experience disease progression or death in the postoperative period
- History of allergy to Clostridium butyricum (live) Tablets (MIYA) or any of its components
- 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)
Other
- Patients who develop severe anastomotic complications postoperatively, such as anastomotic leakage or stenosis
- Patients who require long-term(more than 3 months) use of antibiotics
- Pregnant or lactating women
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huashan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.