Fecal Microbiota Transplantation in the Treatment of Major LARS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: fecal microbiota transplantation, Formulated probiotic supplements.
- Who it may be relevant to
- Registry conditions: Low Anterior Resection Syndrome, Fecal Microbiota Transplantation. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of the Effectiveness of Fecal Microbiota Transplantation in the Treatment of Patients With Severe Low Anterior Resection Syndrome (LARS)
Overview
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.
Interventions
- Biological 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. - Dietary supplement 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.
Primary outcome measures
- bowel function [Time frame: 4 weeks and 8 weeks]
- Shannon index [Time frame: 8 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06475430 · BaS-2406