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Autologous Probiotics in Patients With Defunctioning Ileostomy Following LAR for Rectal Cancer

NCT07366047 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-26

No results posted yet for this study

Summary

Rectal cancer patients who received low anterior resection combined with ileostomy may effectively reduce the probability of anastomotic leakage after surgery. However, due to the long-term semi-abandoned state of the distal colon, the probability of bowel dysfunction after ileostomy closure is very high. The incidence of low anterior resection syndrome (LARS) exceeds 70%, which is twice that of those who did not receive a preventive stoma. The main reasons include postoperative anatomical structure alteration, nerve damage, pathological changes of the colorectal mucosa, and gut microbiota variation, etc. The application of probiotics can significantly improve the bowel function of these patients. In this study, in order to enhance the colonization effect of probiotics, autologous probiotics will be applied to treat patients with defunctioning ileostomy. The primary outcome is the occurrence of major LARS after 6 months of the treatment.

Conditions

  • Rectal Cancer
  • Gut Microbiomes
  • Autologous Probiotic Transplantation
  • Defunctioning Ileostomy

Interventions

DIETARY_SUPPLEMENT

Autologous Probiotics

Patients with defunctioning ileostomy following low anterior resection for rectal cancer, receive autologous probiotics (lactobacillus and bifidobacterium) after ileostomy closure. All patients will take a 100-day supply of high-activity autologous probiotic enteric-coated capsules (100 lactobacillus and 100 bifidobacterium enteric-coated capsules, 1 capsule per day, with each capsule containing a CFU activity of no less than 100 billion)

Sponsors & Collaborators

  • Peking University Cancer Hospital & Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2027-06-30
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07366047 on ClinicalTrials.gov