Fecal Microbiota Transplantation to Relieve Symptoms of Irritable Bowel Syndrome With Constipation

NCT05803993 | Recruiting

• 1 other identifier: 4475
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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 with 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.

Conditions

Irritable Bowel Syndrome

Keywords

Gut microbiota; Fecal microbiota transplantation

Outcome Measures

Primary Outcomes (2)

• 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)

  365 days

• Number and severity grade of adverse events after FMT

  To assess the number and severity grade of adverse events occurred after FMT

  365 days

Secondary Outcomes (2)

• Quality of life related to IBS evaluated with the IBS Quality of Life (IBS-QOL) questionnaire

  365 days

• Engraftment of donor microbiota after FMT, evaluated through the 16s rRNA sequencing

  365 days

Study Arms (2)

FMT from healthy donor

EXPERIMENTAL

Subjects receiving a single infusion FMT via colonoscopy from healthy donor

Procedure: Fecal microbiota transplantation (FMT) Single FMT infusion

Autologous FMT

PLACEBO COMPARATOR

Subjects receiving a single infusion autologous FMT via colonoscopy

Procedure: Fecal microbiota transplantation (FMT) Single FMT infusion

Interventions

Fecal microbiota transplantation (FMT) Single FMT infusion PROCEDURE

Single FMT infusion via colonoscopy

Autologous FMT; FMT from healthy donor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Giovanni Cammarota

Roma, Italy

RECRUITING

Related Publications (5)

• Ianiro G, Masucci L, Quaranta G, Simonelli C, Lopetuso LR, Sanguinetti M, Gasbarrini A, Cammarota G. Randomised clinical trial: faecal microbiota transplantation by colonoscopy plus vancomycin for the treatment of severe refractory Clostridium difficile infection-single versus multiple infusions. Aliment Pharmacol Ther. 2018 Jul;48(2):152-159. doi: 10.1111/apt.14816. Epub 2018 May 30.

  PMID: 29851107 BACKGROUND

• Cammarota G, Ianiro G, Tilg H, Rajilic-Stojanovic M, Kump P, Satokari R, Sokol H, Arkkila P, Pintus C, Hart A, Segal J, Aloi M, Masucci L, Molinaro A, Scaldaferri F, Gasbarrini G, Lopez-Sanroman A, Link A, de Groot P, de Vos WM, Hogenauer C, Malfertheiner P, Mattila E, Milosavljevic T, Nieuwdorp M, Sanguinetti M, Simren M, Gasbarrini A; European FMT Working Group. European consensus conference on faecal microbiota transplantation in clinical practice. Gut. 2017 Apr;66(4):569-580. doi: 10.1136/gutjnl-2016-313017. Epub 2017 Jan 13.

  PMID: 28087657 BACKGROUND

• Ianiro G, Valerio L, Masucci L, Pecere S, Bibbo S, Quaranta G, Posteraro B, Curro D, Sanguinetti M, Gasbarrini A, Cammarota G. Predictors of failure after single faecal microbiota transplantation in patients with recurrent Clostridium difficile infection: results from a 3-year, single-centre cohort study. Clin Microbiol Infect. 2017 May;23(5):337.e1-337.e3. doi: 10.1016/j.cmi.2016.12.025. Epub 2017 Jan 3.

  PMID: 28057560 BACKGROUND

• Cammarota G, Ianiro G, Magalini S, Gasbarrini A, Gui D. Decrease in Surgery for Clostridium difficile Infection After Starting a Program to Transplant Fecal Microbiota. Ann Intern Med. 2015 Sep 15;163(6):487-8. doi: 10.7326/L15-5139. No abstract available.

  PMID: 26370022 BACKGROUND

• Cammarota G, Masucci L, Ianiro G, Bibbo S, Dinoi G, Costamagna G, Sanguinetti M, Gasbarrini A. Randomised clinical trial: faecal microbiota transplantation by colonoscopy vs. vancomycin for the treatment of recurrent Clostridium difficile infection. Aliment Pharmacol Ther. 2015 May;41(9):835-43. doi: 10.1111/apt.13144. Epub 2015 Mar 1.

  PMID: 25728808 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The collected data will be analyzed in blind, as only one person not involved in the activities related to all the procedures of the study will know if faeces will be infused from a healthy donor or if an autologous FMT will be performed
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Recruited subjects will be randomized with 1:1 ratio to receive FMT from healthy donors or autologous FMT (placebo). Patients will be evaluated before FMT and after 30, 60, 90 and 365 days

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: April 7, 2023
• Study Start: December 23, 2021
• Primary Completion: September 23, 2025
• Study Completion: December 23, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)