Probiotics to improve bowel function after ileostomy reversal for ultra‑low rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Single vs. double stapling and purse-string techniques after rectal cancer surgery

  This trial tests whether using a single-stapling method to join the bowel after rectal cancer surgery results in fewer leaks compared with the double-stapling method.

  Recruiting Alexandria University · Alexandria · NCT07929415

• DEM301 in advanced colorectal cancer: a first-in-human test

  This first-in-human Phase 1 study tests DEM301 in adults with advanced metastatic colorectal cancer to see if it is safe, how it behaves in the body, and whether it shows any signs of activity.

  Recruiting at 2 sites Phase 1 DEM BioPharma, Inc. · Birtinya, Queensland and 1 other locations · NCT07805369

• Rectal cancer registry to track real-world treatments and outcomes

  This registry collects real-world data on how locally advanced rectal cancer is treated in Austria, to see how TNT and dMMR/MSI-H cases are managed and what outcomes occur.

  Recruiting at 2 sites Austrian Breast & Colorectal Cancer Study Group · Wiener Neustadt, Lower Austria and 5 other locations · NCT07780305

• Aerobic exercise and guided imagery for bowel problems after rectal cancer surgery

  This study tests whether a program of aerobic exercise plus guided imagery helps people with low anterior resection syndrome after rectal cancer surgery.

  Recruiting Biruni University · Istanbul · NCT07732894

• Active surveillance vs chemoradiotherapy after local removal of intermediate-risk T1 rectal cancer

  This study tests whether close follow-up alone after local removal of early rectal cancer can match the cancer control of adding chemoradiotherapy, while reducing treatment-related side effects.

  Recruiting at 2 sites Medical University of Gdansk · Limoges and 2 other locations · NCT07669298

• Different-Dose Short-Course Radiotherapy With CAPOX, PD-1 Blockade, and IL-2 in Locally Advanced Rectal Cancer

  This phase II trial tests whether a low-dose short-course radiotherapy combined with CAPOX, a PD-1 blocker, and IL-2 works as well as the standard-dose short-course approach in patients with locally advanced rectal cancer.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07646639

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.