Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance (FinFMT-IBS)

Previous studies have shown that stool transplantation (FMT) have positive effect in symptoms for some patients with irritable bowel syndrome (IBS). Studies have shown that it is possible by FMT to reverse the microbiome of the recipient's intestine in the direction of the microbiome of the donor. The effect on eating habits for engraftment of microbiome by FMT is unknown.

The purpose of this study is to investigate whether FMT relieves FODMAP diet extension without worsening intestinal symptoms in IBS patients.

Study Overview

• Status: Recruiting
• Conditions: Irritable Bowel Syndrome; Fecal Microbiota Transplantation
• Intervention / Treatment: Biological: FMT

Detailed Description

This is a plasebo controlled study in which we study the effect and safety of FMT in patients who have IBS and have used FODMAP diet. FMT is assessed by colonoscopy route and therafter the patietns receive twice FMT enema from healthy donor or plasebo..

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Perttu Arkkila, Professor; Phone Number: +35894 +358504272272; Email: perttu.arkkila@hus.fi
• Study Contact Backup: Name: Perttu Lahtinen, Md; Phone Number: +35838192323 +358381911; Email: perttu.lahtinen@phhyky.fi

Study Locations

• Finland
  • Helsinki And Uusimaa
    • Helsinki, Helsinki And Uusimaa, Finland, 00290
      • Recruiting
      • Helsinki University Hospital
      • Contact: Perttu Arkkila, Professor; Phone Number: +35894711 +358504272272; Email: perttu.arkkila@hus.fi
      • Contact: Perttu Arkkila, Md.; Phone Number: +35838192323 +358381911; Email: perttu.lahtinen@phhyky.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults, age 18-75 years, knowledge of the Finnish language
• IBS patients have been diagnosed with the Rome IV- criteria, all IBS-subtypes will be accepted to the trial
• The patient must consume low FODMAP diet to control IBS symptoms
• Patient must sign the informed consent

Exclusion Criteria:

• Diagnosed allergies to food components in the study dietary protocol
• Pregnancy and breastfeeding
• Antibiotic treatment less than three months prior enrolment
• Faecal incontinence, i.e., inability to retain enema
• Abuse of drugs, alcohol or medications
• Other diagnosis besides IBS causing GI symptoms, these include IBD, microscopic colitis, coeliac disease and bile acid diarrhoea.
• Severe psychiatric or neurologic condition decreasing patient's compliance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: FMT form healthy donor; FMT from healthy donor	Biological: FMT; FMT from healthy donor or placebo
PLACEBO_COMPARATOR: FMT plasebo	Biological: FMT; FMT from healthy donor or placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of FMT for tolerance of FODMAPs in the IBS patients' diet	With this study we aim to investigate if FMT treatment promotes inclusion and tolerance of FODMAPs in the IBS patients' diet.	FMT and IBS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbial components explaining the successful broadening of FODMAP diet in IBS patients.	We aim to investigate what are the microbial components explaining the successful broadening of their diet and identify microbial taxa engrafted from the donor explaining the dietary modifications.	Microbiome and FODMAP
GI symptoms and bacterial fermentaiton status in IBS	Aim to investigate the gastrointestinal symptom change and see how changes in bacterial fermentation status (detected with hydrogen breath test) modulates the patients' symptoms and if this is related to the FMT treatment.	Bacterial fermentation status and IBS

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: Turku University Hospital; University of Helsinki; Paijat-Hame Hospital District
• Investigators: Principal Investigator: Perttu Arkkila, Professor, Head physician; Study Chair: Perttu Lahtinen, Md., Head physician

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 30, 2022
• Primary Completion (ANTICIPATED): July 31, 2024
• Study Completion (ANTICIPATED): July 31, 2026

Study Registration Dates

• First Submitted: April 30, 2022
• First Submitted That Met QC Criteria: April 30, 2022
• First Posted (ACTUAL): May 5, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: IBS; FMT; FODMAP
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Food Intolerance
• Other Study ID Numbers: 1480/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pseudoanonymous data is available to other reserchers
• IPD Sharing Time Frame: 31 July 2025 for one yrear.
• IPD Sharing Access Criteria: Scientific work
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No