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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Huashan Hospital Fudan University
RECRUITING
Shanghai
Contact Information
Primary
LI Zhenyang, Doctor
13764030915@163.com
+86-13764030915
Backup
Xiang Jianbin, Doctor
xjbzhw@163.com
+86-13476272860
Time Frame
Start Date: 2025-10-15
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 156
Treatments
Experimental: high dose group
the high dose group received interventions (4 Clostridium butyricum (live) Tablets(Meiya), administered into the dysfunctional intestine twice a week) starting 1 week after the ileostomy
Experimental: low dose group
the low dose group received interventions (4 Clostridium butyricum (live) Tablets(Meiya), administered into the dysfunctional intestine once a week) starting 1 week after the ileostomy
No_intervention: control group
the control group received routine postoperative follow-up
Related Therapeutic Areas
Sponsors
Collaborators: Characteristic Medical Center of Rocket Army, Ruijin Hospital, The First Affiliated Hospital of Nankai University, Zhongnan Hospital, First Affiliated Hospital of Fujian Medical University, Nanfang Hospital, Southern Medical Universit
Leads: Huashan Hospital

This content was sourced from clinicaltrials.gov