TRApianto di Microbiota Intestinale in Pazienti Affetti da Sindrome Dell'Intestino IRritabile Senza Stipsi: Studio Clinico Randomizzato Controllato in Singolo Centro

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Giovanni Cammarota
RECRUITING
Roma
Time Frame
Start Date: 2021-12-23
Estimated Completion Date: 2025-12-23
Participants
Target number of participants: 35
Treatments
Experimental: FMT from healthy donor
Subjects receiving a single infusion FMT via colonoscopy from healthy donor
Placebo_comparator: Autologous FMT
Subjects receiving a single infusion autologous FMT via colonoscopy
Sponsors
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov

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