Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT05361785

Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance

Led by Helsinki University Central Hospital · Updated on 2022-05-13

45

Participants Needed

1

Research Sites

221 weeks

Total Duration

On this page

Sponsors

H

Helsinki University Central Hospital

Lead Sponsor

T

Turku University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults, age 18-75 years, knowledge of the Finnish language
  • IBS patients diagnosed with Rome IV criteria, all IBS subtypes accepted
  • Currently consuming a low FODMAP diet to control IBS symptoms
  • Patient must sign the informed consent
Not Eligible

You will not qualify if you...

  • Diagnosed allergies to food components in the study dietary protocol
  • Pregnancy and breastfeeding
  • Antibiotic treatment less than three months prior enrolment
  • Faecal incontinence, inability to retain enema
  • Abuse of drugs, alcohol, or medications
  • Other gastrointestinal diagnoses causing symptoms, including IBD, microscopic colitis, coeliac disease, and bile acid diarrhoea
  • Severe psychiatric or neurologic condition reducing patient compliance

AI-Screening

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Trial Site Locations

Total: 1 location

1

Helsinki University Hospital

Helsinki, Helsinki and Uusimaa, Finland, 00290

Actively Recruiting

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Research Team

P

Perttu Arkkila, Professor

CONTACT

P

Perttu Lahtinen, Md

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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