The Impact of Probiotic Intervention on the Gut Microbiota and Bowel Function (NCT07369830) | Clinical Trial Compass
RecruitingNot Applicable
The Impact of Probiotic Intervention on the Gut Microbiota and Bowel Function
China156 participantsStarted 2025-10-15
Plain-language 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
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. Does not meet the surgical indications for Intersphincteric Resection (ISR)
✕. Presence of multiple primary colorectal malignancies
✕. Patients who have received neoadjuvant radiotherapy
Timeframe: 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.