Clinical trial NCT05361785: Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance
Official title: Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Irritable Bowel Syndrome
Fecal Microbiota Transplantation
Keywords: FMT
IBS
FODMAP
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Turku University Hospital
name: University of Helsinki
name: Paijat-Hame Hospital District
First posted: 2022-05-05
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: RCT, randomaization 2/3 FMT, 1/3 placebo
Primary purpose: TREATMENT

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..

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

Primary outcomes:
measure: The effect of FMT for tolerance of FODMAPs in the IBS patients' diet
timeFrame: FMT and IBS
Secondary outcomes:
measure: Microbial components explaining the successful broadening of FODMAP diet in IBS patients.
timeFrame: Microbiome and FODMAP
measure: GI symptoms and bacterial fermentaiton status in IBS
timeFrame: Bacterial fermentation status and IBS
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
state: Helsinki And Uusimaa
Study officials:
affiliation: Head physician
name: Perttu Arkkila, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Head physician
name: Perttu Lahtinen, Md.
role: STUDY_CHAIR
References: