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

NCT07366047 | Not Yet Recruiting

• 1 other identifier: A-PILLAR
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of participants with major low anterior resection syndrome score (LARS score)

  at the time of 6 months since the start of treatment

Secondary Outcomes (4)

• Quality of life impairment assessed by Short Form 36 (SF-36)

  at the time of 1, 3, 6, 12 months since the start of treatment

• Number of participants with major low anterior resection syndrome score (LARS score)

  at the time of1, 3, 6, 12months since the start of treatment

• Bowel function impairment

  at the time of 1, 3, 6, 12 months since the start of treatment

• Fecal continence impairment

  at the time of 6, 12 months since the start of treatment

Study Arms (1)

Autologous Probiotics Transplantation

EXPERIMENTAL

Patients with defunctioning ileostomy following low anterior resection for rectal cancer, receive autologous probiotic (lactobacillus and bifidobacterium) after ileostomy closure.

Dietary Supplement: Autologous Probiotics

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)

Autologous Probiotics Transplantation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-80years old; Curative low anterior resection for rectal cancer with defunctioning ileostomy; ileostomy closure within 3-6 month; Preoperative chemoradiotherapy ; No evidence of anastomotic leakage or severe stenosis

You may not qualify if:

• Tumor recurrence or distant metastasis; Secondary operation with stoma; Prior disease impairing bowel function except for rectal cancer; Any contraindication for transanal irrigation; Pregnant or nursing; Serious cardiovascular disease, uncontrolled infections, or other serious uncontrolled concomitant disease; Cognitive or psychological disorder;

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Lin Wang

CONTACT

86-10-88196086; wanglinmd@foxmail.com

Jianning Zhai

CONTACT

jianningzhai@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: surgeon-in-charge

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 26, 2026
• Study Start: December 31, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 26, 2026

Record last verified: 2025-07