An interventional study of Fecal microbiota transplantation (FMT) in Irritable Bowel Syndrome, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-11.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Treatment
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.
Irritable bowel syndrome (IBS) is a common chronic functional disorder with a prevalence varying between 10 and 15%. IBS is characterized by recurrent chronic abdominal pain associated with altered defecation. Intestinal dysbiosis is thought to be one of the major drivers in IBS pathophysiology, since several studies have shown that there are substantial differences in microbial composition between IBS patients and healthy subjects. Moreover, the modulation of the gut microbiota in IBS patients seems a promising therapeutic approach, since a benefit on symptoms with certain antibiotics, probiotics, prebiotics, synbiotics and diet has been reported. Fecal microbiota transplantation (FMT) from healthy donors is generally considered a safe and well-tolerated procedure ant it is described to be capable of restoring eubiosis of the recipient in the long term. Recently, a certain effectiveness of FMT in ameliorating intestinal symptoms, psychological aspects and quality of life alongside with a restoration of eubiosis among IBS patients has been described. This is a prospective randomized double-blind placebo-controlled trial aimed at estimating the benefits of FMT among IBS patients without constipation. The assessment of the effectiveness on IBS symptoms and quality of life, the evaluation of the safety and the changes in the gut microbiota composition (performed with shotgun sequencing techniques) among IBS patients will be evaluated before after the FMT. 35 patients will be enrolled in 24 months. Recruited subjects will be randomized with 1:1 ratio to receive FMT from healthy donors or autologous FMT (placebo). The effectiveness of FMT in improving the IBS symptoms and IBS-related quality of life will be estimated with the IBS-SSS and IBS-QOL questionnaire, respectively, before FMT and after 30, 60, 90 and 365 days. Moreover, the frequency and form of evacuations according to the Bristol scale will be recorded at the same timepoints from diaries provided to the patients. Changes in gut microbiota composition will be estimated by comparing the composition of the faecal microbiota of the recipient before and 90 days after the FMT. The data will be evaluated using Intention-to-treat (ITT) statistical analysis and per-protocol (PP) analysis. Difference between the two groups will be calculated by two-tailed tests, Wilcoxon-Rank Sum Test for continuous variables and by the Fisher's exact probability test for categorical variables. The response rate to FMT will be evaluated by the Fisher's exact test. Adverse events will be assessed. The composition of the faecal microbiota of the recipient before and after the FMT will also be analysed and also compared with the healthy donor's one using the UniFrac method.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 189 are open to participants now.
This study's planned enrollment of 35 is below the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.
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Exclusion Criteria:
Subjects receiving a single infusion FMT via colonoscopy from healthy donor
Procedure: Fecal microbiota transplantation (FMT)
Subjects receiving a single infusion autologous FMT via colonoscopy
Procedure: Fecal microbiota transplantation (FMT)
Single FMT infusion via colonoscopy
Improving IBS symptoms assessed with the IBS severity scoring system (IBS-SSS)
To assess the effectiveness of healthy donor FMT in improving the symptoms of IBS without constipation compared to autologous microbiota transplantation using the IBS-SSS (\< 175: mild IBS; 175-300: moderate IBS; \> 300: severe IBS)
Time frame: 365 days
Number and severity grade of adverse events after FMT
To assess the number and severity grade of adverse events occurred after FMT
Time frame: 365 days
Quality of life related to IBS evaluated with the IBS Quality of Life (IBS-QOL) questionnaire
To assess the effectiveness of healthy donor gut microbiota transplantation in improving the quality of life of patients with IBS without constipation compared to autologous FMT using the IBS-QOL questionnaire (range: 34-170; lower scores indicate better IBS-QoL)
Time frame: 365 days
Engraftment of donor microbiota after FMT, evaluated through the 16s rRNA sequencing
Changes in the fecal microbiota of the recipients after FMT from healthy donor or autologous microbiota transplantation will be evaluated through the 16s rRNA sequencing and compared to the baseline condition
Time frame: 365 days
Plan to share: No
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS