Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance

NCT05361785 | Recruiting

• 1 other identifier: 1480/2021
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Irritable Bowel Syndrome; Fecal Microbiota Transplantation

Keywords

FMT; IBS; FODMAP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Microbial components explaining the successful broadening of FODMAP diet in IBS patients.

  Microbiome and FODMAP

• GI symptoms and bacterial fermentaiton status in IBS

  Bacterial fermentation status and IBS

Study Arms (2)

FMT form healthy donor

ACTIVE COMPARATOR

FMT from healthy donor

Biological: FMT

FMT plasebo

PLACEBO COMPARATOR

FMT plasebo

Biological: FMT

Interventions

FMT BIOLOGICAL

FMT from healthy donor or placebo

FMT form healthy donor; FMT plasebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• Turku University Hospital: collaborator
• University of Helsinki: collaborator
• Paijat-Hame Hospital District: collaborator

Study Sites (1)

Helsinki University Hospital

Helsinki, Helsinki and Uusimaa, 00290, Finland

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Perttu Arkkila, Professor

  Head physician

  PRINCIPAL INVESTIGATOR

• Perttu Lahtinen, Md.

  Head physician

  STUDY CHAIR

Central Study Contacts

Perttu Arkkila, Professor

CONTACT

+358504272272; perttu.arkkila@hus.fi

Perttu Lahtinen, Md

CONTACT

+358381911; perttu.lahtinen@phhyky.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Coputer based randomization
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: RCT, randomaization 2/3 FMT, 1/3 placebo

Study Record Dates

• First Submitted: April 30, 2022
• First Posted: May 5, 2022
• Study Start: April 30, 2022
• Primary Completion: July 31, 2024
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 13, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 31 July 2025 for one yrear.
• Access Criteria: Scientific work

Locations

FI (1)