Fecal microbiota transplantation for irritable bowel syndrome without constipation
Official title: TRApianto di Microbiota Intestinale in Pazienti Affetti da Sindrome Dell'Intestino IRritabile Senza Stipsi: Studio Clinico Randomizzato Controllato in Singolo Centro
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT05803980 · Data updated 2026-11-12
This study is testing whether a treatment called fecal microbiota transplantation can help people with irritable bowel syndrome who don’t have constipation feel better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 35 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Status | Recruiting |
| Started | December 23, 2021 |
| Main results expected | September 23, 2025 |
| Study ends | December 23, 2025 |
| Registry record updated | March 11, 2025 |
| Trial ID | NCT05803980 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older diagnosed with diarrhea-predominant or unclassified IBS according to the Rome IV criteria.
✕Probably not a fit
Patients with chronic inflammatory bowel diseases, severe heart or respiratory conditions, or those who have had recent gastrointestinal surgeries may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the use of fecal microbiota transplantation (FMT) as a treatment for patients diagnosed with irritable bowel syndrome (IBS) without constipation. Participants will be randomly assigned to receive either FMT from a healthy donor or a placebo (autologous FMT) in a double-blind manner. The study aims to assess the effectiveness of FMT on IBS symptoms and quality of life, evaluate its safety, and analyze changes in gut microbiota composition using advanced sequencing techniques. A total of 35 patients will be enrolled to determine the potential benefits of this innovative approach.
Why it matters
Potential benefit: If successful, this treatment could significantly improve symptoms and quality of life for patients suffering from IBS without constipation.
How similar studies have gone: Previous studies have shown promising results for fecal microbiota transplantation in improving symptoms of IBS, indicating that this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Giovanni Cammarota
Roma, Italy Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.