Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHelsinki University Central Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
FMT
Biological/VaccineFMT from healthy donor or placebo
Treatment groups
45 Participants
are divided into 2 treatment groupsGroup A: FMT form healthy donorActive comparator 1 intervention
Group B: FMT plaseboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
FMT and IBSSecondary outcomes
1
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.
Time frame
Microbiome and FODMAP2
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.
Time frame
Bacterial fermentation status and IBSSponsors and contacts
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Helsinki University Central Hospital
Lead sponsor
Turku University Hospital
Collaborator
University of Helsinki
Collaborator
Paijat-Hame Hospital District
Collaborator
Source ClinicalTrials.gov