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

ConditionRectal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHuashan Hospital

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Does not meet the surgical indications for Intersphincteric Resection (ISR)

Presence of multiple primary colorectal malignancies

Patients who have received neoadjuvant radiotherapy

Patients who experience disease progression or death in the postoperative period

Trial design

Treatments tested in this trial

  • Clostridium butyricum (live) Tablets(Meiya)

Treatment groups

156 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Huashan Hospital

Lead sponsor

Characteristic Medical Center of Rocket Army

Collaborator

Zhongnan Hospital

Collaborator

The First Affiliated Hospital of Nankai University

Collaborator

First Affiliated Hospital of Fujian Medical University

Collaborator

Ruijin Hospital

Collaborator

Nanfang Hospital, Southern Medical University

Collaborator