Fecal Microbiota Transplantation in the Treatment of Major LARS

Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · Jun 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called fecal microbiota transplantation (FMT) to see if it can help improve bowel function in patients with Major Low Anterior Resection Syndrome (LARS), a condition that can cause difficulties with bowel control after surgery for rectal cancer. The trial will involve 40 participants who will be randomly assigned to receive either FMT or a probiotic supplement. Researchers will track participants' bowel symptoms for four weeks and analyze their gut bacteria for eight weeks to see how well the treatment works.

To be eligible for this trial, participants must be at least 18 years old and have had surgery for rectal cancer at least three months prior, with a specific score indicating the severity of their LARS. They should be in relatively good health, as indicated by a performance status score, and must agree to participate by signing a consent form. However, certain individuals, such as those with specific pre-existing conditions or recent use of antibiotics, may not be able to join. Participants can expect support and monitoring throughout the study, and it’s important to note that the trial is not yet recruiting patients.

Gender

ALL

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.