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Clinical Trials in China / NCT07369830
Recruiting Not applicable

The Impact of Probiotic Intervention on the Gut Microbiota and Bowel Function

NCT07369830 · tracked via the Priya Life Science China tracker
Sponsor
Huashan Hospital
Phase
Not applicable
Started
2025-10-15
Last updated
2026-01-27

Condition(s) studied

Rectal Cancer

Investigational drug(s) / intervention(s)

Clostridium butyricum (live) Tablets(Meiya) →

Clostridium butyricum (live) Tablets(Meiya): Clostridium butyricum (live) Tablet administered into the dysfunctional intestine for low dose and high dose group, while control group has no intervention

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Low Anterior Resection Syndrome Score（LARS Score） — One month after stoma reversal
    Comparison of LARS scores among the three groups at one month postoperatively. Low Anterior Resection Syndrome (LARS) is characterized by major symptoms including difficulty defecating, urgency, incontinence of liquid stool, incontinence of flatus, and increased frequency of bowel movements. Based on severity, LARS can be classified as none (0-20 points), minor (21-29 points), or major (30-42 points) using LARS score. And higher scores mean a worse outcome.
  • microbial diversity — The first stool sample will be collected within one week before ISR surgery, and the second stool sample will be collected within three to five days after stoma reversal, upon the first bowel movement.
    Fecal samples from study participants with ISR preoperatively and postoperatively will be collected to analyze the alpha and beta diversity of gut microbiota among the three groups

Trial sites (1)

FacilityCityRegionStatus
Huashan Hospital Fudan University Shanghai Shanghai Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07369830 on ClinicalTrials.gov ↗ ← All trials in China