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

Sponsor
Peking University Cancer Hospital & Institute
Study ID
NCT07366047
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Autologous Probiotics — DIETARY_SUPPLEMENT
    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)

Study Details

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.

Key Dates

First listed
Jan 26, 2026
Start date
Dec 31, 2025
Status verified
Jul 2025
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Autologous Probiotics Transplantation
    Patients with defunctioning ileostomy following low anterior resection for rectal cancer, receive autologous probiotic (lactobacillus and bifidobacterium) after ileostomy closure.

Primary Outcome Measure

Number of participants with major low anterior resection syndrome score (LARS score) [ Time Frame: at the time of 6 months since the start of treatment ]

Central Contacts

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