Using fecal microbiota transplantation to treat constipation in IBS patients
Official title: TRApianto di Microbiota Intestinale in Pazienti Affetti da Sindrome Dell'Intestino IRritabile Con Stipsi: Studio Clinico Randomizzato Controllato in Singolo Centro
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT05803993 · Data updated 2026-11-12
This study is testing whether a treatment using healthy gut bacteria can help people with irritable bowel syndrome who 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 | NCT05803993 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 constipation-predominant or mixed/alternating stool pattern IBS.
✕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 effectiveness of fecal microbiota transplantation (FMT) in patients diagnosed with irritable bowel syndrome (IBS) characterized by constipation. Participants will be randomly assigned to receive either FMT from healthy donors or a placebo (autologous FMT) in a double-blind manner. The study aims to assess improvements in IBS symptoms, quality of life, and changes in gut microbiota composition following the treatment. A total of 35 patients will be enrolled, and their safety will also be evaluated throughout the trial.
Why it matters
Potential benefit: If successful, this approach could significantly alleviate symptoms and improve the quality of life for patients suffering from IBS with 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 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
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.