Fecal Microbiota Transplantation to Relieve Symptoms of Irritable Bowel Syndrome With Constipation

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

Keywords

ClinConnect Summary

This clinical trial is studying whether fecal microbiota transplantation (FMT) can help relieve symptoms of irritable bowel syndrome (IBS) with constipation. IBS is a condition that affects how the digestive system works and can cause discomfort, bloating, and changes in bowel habits. In this trial, participants will be randomly assigned to receive either FMT from a healthy donor or a placebo treatment. The goal is to see if FMT can improve IBS symptoms, enhance quality of life, and change the bacteria in the gut for the better.

To be eligible for the trial, participants must be at least 18 years old and have a diagnosis of IBS with constipation, confirmed by a recent colonoscopy that rules out other intestinal diseases. Those who have taken antibiotics or probiotics in the last two months or have certain medical conditions, like chronic inflammatory bowel disease or severe heart issues, cannot participate. If you join the study, you can expect to undergo FMT and be monitored for its effects on your symptoms and overall health. This trial is currently recruiting participants of all genders within the age range of 18 and older.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Ability to express and give informed consent
• • Age ≥ 18 years
• • Diagnosis of constipation-predominant or with mixed/alternating stool pattern 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