Fecal Microbiota Transplantation to Relieve Symptoms of Irritable Bowel Syndrome Without Constipation
Key facts
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Where
- Roma, ItalySee the site
- Trial code
- Status
- Recruiting
- People taking part
- 35 people, planned
- Started
- 23 Dec 2021
- Planned end
- 23 Dec 2025
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Fecal microbiota transplantation (FMT)
- Record updated
- 11 March 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- Taking antibiotics or probiotics within the 8 weeks before the baseline visit
- 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)
- Concurrent enrollment in other interventional experimental protocols
- 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
- Any clinical condition which, in the opinion of the investigators, may contraindicate enrollment in the study
- Patients with cutaneous enterostomy
- Pregnancy or lactation
- Personality unstable or unable to adhere to protocol procedures
Where in Italy
- Giovanni CammarotaRoma, ItalyContact: Giovanni CammarotaTaking people
About the trial
What the trial wants to find out
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 without 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.
The 2 groups in the trial
- FMT from healthy donorTreatment being tested
Subjects receiving a single infusion FMT via colonoscopy from healthy donor
Treatment: Fecal microbiota transplantation (FMT)
- Autologous FMTPlacebo, for comparison
Subjects receiving a single infusion autologous FMT via colonoscopy
Treatment: Fecal microbiota transplantation (FMT)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- TRApianto di Microbiota Intestinale in Pazienti Affetti da Sindrome Dell'Intestino IRritabile Senza Stipsi: Studio Clinico Randomizzato Controllato in Singolo Centro
- Record updated
- 11 March 2025