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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Irritable Bowel Syndrome

In brief

Irritable bowel syndrome (IBS) is a complex multifactorial functional disorder, whose pathophysiology is largely associated to an impairment of the intestinal microbiota composition, namely dysbiosis. Thus, the modulation of the gut microbiota has been proposed as a possible therapeutic strategy for IBS patients alongside with current available drugs. Fecal microbiota transplantation (FMT) is a promising strategy to restore intestinal eubiosis. In this randomised double-blind placebo-controlled trial patients diagnosed with IBS with constipation are assigned with 1:1 ratio to receive FMT from healthy donor or autologous FMT (placebo group) to assess the effectiveness of FMT on IBS symptoms and quality of life, to evaluate the safety of FMT among IBS patients and to estimate any change in the gut microbiota composition of IBS patients after the FMT.

Key facts

Study ID

NCT05803993

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

35

Starts

2021-12-23

Expected to finish

2025-12-23

Last updated by the study team

2025-03-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Giovanni Cammarota — Roma, Italy (enrolling)

Full record on ClinicalTrials.gov

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