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

Primary Purpose

Irritable Bowel Syndrome, Fecal Microbiota Transplantation

Status

Recruiting

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

FMT

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring FMT, IBS, FODMAP

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Helsinki University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

FMT form healthy donor

FMT plasebo

Arm Description

FMT from healthy donor

FMT plasebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT05361785

First Posted

April 30, 2022

Last Updated

May 9, 2022

Sponsor

Helsinki University Central Hospital

Collaborators

Turku University Hospital, University of Helsinki, Paijat-Hame Hospital District

1. Study Identification

Unique Protocol Identification Number

NCT05361785

Brief Title

Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance

Acronym

FinFMT-IBS

Official Title

Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 30, 2022 (Actual)

Primary Completion Date

July 31, 2024 (Anticipated)

Study Completion Date

July 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Helsinki University Central Hospital

Collaborators

Turku University Hospital, University of Helsinki, Paijat-Hame Hospital District

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome, Fecal Microbiota Transplantation

Keywords

FMT, IBS, FODMAP

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

RCT, randomaization 2/3 FMT, 1/3 placebo

Masking

Investigator

Masking Description

Coputer based randomization

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FMT form healthy donor

Arm Type

Active Comparator

Arm Description

FMT from healthy donor

Arm Title

FMT plasebo

Arm Type

Placebo Comparator

Arm Description

FMT plasebo

Intervention Type

Biological

Intervention Name(s)

FMT

Intervention Description

FMT from healthy donor or placebo

Primary Outcome Measure Information:

Title

The effect of FMT for tolerance of FODMAPs in the IBS patients' diet

Description

With this study we aim to investigate if FMT treatment promotes inclusion and tolerance of FODMAPs in the IBS patients' diet.

Time Frame

FMT and IBS

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Microbiome and FODMAP

Title

GI symptoms and bacterial fermentaiton status in IBS

Description

Time Frame

Bacterial fermentation status and IBS

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Perttu Arkkila, Professor

Phone

+358504272272

Ext

+35894

perttu.arkkila@hus.fi

First Name & Middle Initial & Last Name or Official Title & Degree

Perttu Lahtinen, Md

Phone

+358381911

Ext

+35838192323

perttu.lahtinen@phhyky.fi

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Perttu Arkkila, Professor

Organizational Affiliation

Head physician

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Perttu Lahtinen, Md.

Organizational Affiliation

Head physician

Official's Role

Study Chair

Facility Information:

Facility Name

Helsinki University Hospital

City

Helsinki

State/Province

Helsinki And Uusimaa

ZIP/Postal Code

00290

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Perttu Arkkila, Professor

Phone

+358504272272

Ext

+35894711

perttu.arkkila@hus.fi

First Name & Middle Initial & Last Name & Degree

Perttu Arkkila, Md.

Phone

+358381911

Ext

+35838192323

perttu.lahtinen@phhyky.fi

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance

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