Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance

Irritable Bowel Syndrome Clinical Trial

— FinFMT-IBS  

Official title:

Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05361785
• Other study ID #: 1480/2021
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2022
• Est. completion date: July 31, 2026

Study information

• Verified date: May 2022
• Source: Helsinki University Central Hospital
• Contact: Perttu Arkkila, Professor
• Phone: +358504272272
• Email: perttu.arkkila[@]hus.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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..

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fecal Microbiota Transplantation
• Food Intolerance
• Irritable Bowel Syndrome
• Syndrome

Intervention

Biological:
• FMT
FMT from healthy donor or placebo

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki	Helsinki And Uusimaa

Sponsors (4)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Paijat-Hame Hospital District, Turku University Hospital, University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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