Fecal Microbiota Transplantation to Relieve Symptoms of Irritable Bowel Syndrome Without Constipation

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Mar 27, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called fecal microbiota transplantation (FMT) to help relieve symptoms of irritable bowel syndrome (IBS) in patients who do not experience constipation. IBS is a condition that affects the digestive system, and researchers believe that changing the bacteria in the gut may improve symptoms and overall quality of life for patients. In this study, participants will be randomly assigned to receive either FMT from a healthy donor or a placebo treatment, which means they won't know which one they are receiving. The goal is to see if FMT can effectively reduce IBS symptoms and whether it is safe for patients.

To participate in this trial, individuals must be at least 18 years old and have a specific type of IBS, confirmed by a medical examination in the past five years. They should not be taking antibiotics or probiotics within the last two months, nor have certain severe health conditions, such as chronic inflammatory bowel disease or serious heart problems. Participants can expect to undergo the FMT procedure and be monitored for any changes in their symptoms and gut bacteria after the treatment. This study is currently recruiting, and it aims to provide insights into how FMT might be a beneficial option for managing IBS symptoms.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Ability to express and give informed consent
• • Age ≥ 18 years
• • Diagnosis of diarrhoea-predominant or unclassified IBS, according to the Rome IV criteria
• • Have performed a colonoscopy within the last 5 years that has ruled out intestinal diseases
• Exclusion Criteria:
• • Taking antibiotics or probiotics within the 8 weeks before the baseline visit
• • Patients with chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis, indeterminate colitis or eosinophilic gastroenteritis), malignant neoplasms of the gastroenteric tract, celiac disease, diverticular disease
• • Uncontrolled heart failure or severe heart disease with EF \< 30%
• • Severe respiratory failure
• • Serious psychiatric conditions or psychological instability according to the clinician
• • Contraindication to fecal microbiota transplantation (high risk of complications related to colonoscopy)
• • Previous abdominal surgery on the gastroenteric tract (except cholecystectomy, appendectomy and other types of surgery not involving the digestive tract)
• • Patients with cutaneous enterostomy
• • Pregnancy or lactation
• • Concurrent enrollment in other interventional experimental protocols
• • Personality unstable or unable to adhere to protocol procedures
• • Any clinical condition which, in the opinion of the investigators, may contraindicate enrollment in the study