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

Helsinki University Central Hospital (HUCH)

Status: Enrolling

Conditions: Irritable Bowel Syndrome; Fecal Microbiota Transplantation

Treatments: Biological: FMT

Study type: Interventional

Funder types: Other

Identifiers

NCT05361785

1480/2021

Details and patient eligibility

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.

Full 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..

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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45 participants in 2 patient groups, including a placebo group

FMT form healthy donor

Active Comparator group

Description:

FMT from healthy donor

Treatment:

Biological: FMT

FMT plasebo

Placebo Comparator group

Description:

FMT plasebo

Treatment:

Biological: FMT