Fecal Microbiota Transplantation in the Treatment of Major LARS

NCT ID: NCT06475430

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-12-31

Brief Summary

Randomized trial to assess FMT efficacy in improving bowel function for major LARS patients. 40 subjects, blinded, randomized to FMT or probiotics. Pre-post 16S sequencing, 4-week follow-up for bowel symptoms, 8-week microbiota analysis.

Detailed Description

This study is a rigorous single-center, prospective, double-blinded, randomized controlled trial, aiming to evaluate the effectiveness of fecal microbiota transplantation (FMT) in improving bowel function for patients with major low anterior resection syndrome (LARS). A total of 40 subjects are planned to be recruited and randomly assigned to the experimental group and the control group at a 1:1 ratio. Prior to treatment, all subjects will undergo 16S sequencing of intestinal microbiota to assess their intestinal microecological status. During the treatment, a colonoscopic colonic catheter will be placed via the anus, with the experimental group receiving FMT solution matched to the patient's microbiota for intra-intestinal administration, while the control group will receive a standardized probiotic formula. To ensure the impartiality of the study, both patients and researchers administering the medication will be blinded to the trial drugs. The study will continuously observe and record bowel symptoms after 4 weeks of treatment as well as 16S sequencing results of intestinal microbiota after 8 weeks. Upon the completion of the entire study, the blinding will be revealed, and the results will be analyzed.

Conditions

Low Anterior Resection Syndrome; Fecal Microbiota Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Fecal flora transplantation group

Group Type: EXPERIMENTAL

fecal microbiota transplantation

Intervention Type: BIOLOGICAL

During the treatment, a colonoscopic colonic catheter will be placed via the anus, with the experimental group receiving FMT solution matched to the patient's microbiota for intra-intestinal administration.

Formulated probiotics group

Group Type: ACTIVE_COMPARATOR

Formulated probiotic supplements

Intervention Type: DIETARY_SUPPLEMENT

During the treatment, a colonoscopic colonic catheter will be placed via the anus, with the control group receiving a standardized probiotic formula.

Interventions

fecal microbiota transplantation

During the treatment, a colonoscopic colonic catheter will be placed via the anus, with the experimental group receiving FMT solution matched to the patient's microbiota for intra-intestinal administration.

Intervention Type: BIOLOGICAL

Formulated probiotic supplements

During the treatment, a colonoscopic colonic catheter will be placed via the anus, with the control group receiving a standardized probiotic formula.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

FMT; probiotic

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years old, regardless of gender; Patients with rectal cancer who have undergone total mesorectal excision (TME) and sphincter-preserving surgery, and the postoperative period is more than 3 months; Patients with a LARS score of 21 to 42; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Expected survival period ≥ 1 year; Voluntarily sign a written informed consent form.

Exclusion Criteria

• Patients with pre-operative symptoms of fecal and urinary incontinence; Patients who have undergone pelvic surgery or LAR due to non-cancerous reasons; Patients who have undergone pelvic radiotherapy; Patients with prophylactic ostomy; Patients who have used any antibiotic medication, probiotic products, or prebiotic products in the past 4 weeks; Patients who have regularly used laxatives in the past two weeks; Pregnant or lactating women; Human immunodeficiency virus (HIV) positive; Known history of active pulmonary tuberculosis (TB). Subjects suspected of having active TB require chest X-ray, sputum examination, and exclusion based on clinical symptoms and signs; Untreated patients with chronic hepatitis B or HBV carriers with HBV DNA exceeding 500 IU/mL, or patients with active hepatitis C should be excluded. Non-active HBsAg carriers, treated and stable hepatitis B patients (HBV DNA < 500 IU/mL), and cured hepatitis C patients can be enrolled. For subjects with positive HCV antibodies, only those with negative HCV RNA test results are eligible to participate in the study; Known history of psychiatric drug abuse, alcoholism, and drug abuse; Patients with cognitive impairment; Any situation where the investigator believes the participant should be excluded from the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fan Liu

Fan Liu

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Fan Liu, Doctor

Role: CONTACT

liufan92@pkuph.edu.cn

01088326600

Chang Wang, Doctor

Role: CONTACT

wangchang@pkuph.edu.cn

15210196608

Other Identifiers

BaS-2406

Identifier Type: -

Identifier Source: org_study_id