Fecal Microbiota Transplantation in the Treatment of Major LARS

NCT06475430 | Not Yet Recruiting DMC

• 1 other identifier: BaS-2406
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Low Anterior Resection Syndrome; Fecal Microbiota Transplantation

Keywords

low anterior resection syndrome; bowel function; fecal microbiota transplantation; intestinal microbiota

Outcome Measures

Primary Outcomes (2)

• bowel function

  LARS score

  4 weeks and 8 weeks

• Shannon index

  biodiversity monitoring

  8 weeks

Study Arms (2)

Fecal flora transplantation group

EXPERIMENTAL

Biological: fecal microbiota transplantation

Formulated probiotics group

ACTIVE COMPARATOR

Dietary Supplement: Formulated probiotic supplements

Interventions

fecal microbiota transplantation 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.

Also known as: FMT

Fecal flora transplantation group

Formulated probiotic supplements DIETARY_SUPPLEMENT

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

Also known as: probiotic

Formulated probiotics group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

MeSH Terms

Conditions

Low Anterior Resection Syndrome

Interventions

Fecal Microbiota Transplantation; Probiotics

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Fan Liu, Doctor

CONTACT

01088326600; liufan92@pkuph.edu.cn

Chang Wang, Doctor

CONTACT

15210196608; wangchang@pkuph.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fan Liu

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 26, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share