Fecal Microbiota Transplantation, Irritable Bowel Syndrome
Conditions
Keywords
FMT, IBS, FODMAP
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..
Interventions
BIOLOGICALFMT
FMT from healthy donor or placebo
Sponsors
Turku University Hospital
University of Helsinki
Paijat-Hame Hospital District
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Coputer based randomization
Intervention model description
RCT, randomaization 2/3 FMT, 1/3 placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effect of FMT for tolerance of FODMAPs in the IBS patients' diet | FMT and IBS | With this study we aim to investigate if FMT treatment promotes inclusion and tolerance of FODMAPs in the IBS patients' diet. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbial components explaining the successful broadening of FODMAP diet in IBS patients. | Microbiome and FODMAP | 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. |
| GI symptoms and bacterial fermentaiton status in IBS | Bacterial fermentation status and 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. |
Countries
Finland
Contacts
Primary ContactPerttu Arkkila, Professor
Backup ContactPerttu Lahtinen, Md
Outcome results
None listed