NCT05803993 Fecal Microbiota Transplantation to Relieve Symptoms of Irritable Bowel Syndrome With Constipation
| NCT ID | NCT05803993 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Irritable Bowel Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2021-12-23 |
| Primary Completion | 2025-09-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 35 participants in total. It began in 2021-12-23 with a primary completion date of 2025-09-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Frequently Asked Questions
Who can join the NCT05803993 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Irritable Bowel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05803993 currently recruiting?
Yes, NCT05803993 is actively recruiting participants. Visit ClinicalTrials.gov or contact Fondazione Policlinico Universitario Agostino Gemelli IRCCS to inquire about joining.
Where is the NCT05803993 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT05803993 clinical trial?
NCT05803993 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 35 participants.