RecruitingNot ApplicableNCT05361785

Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance


Sponsor

Helsinki University Central Hospital

Enrollment

45 participants

Start Date

Apr 30, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

  • 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 Criteria7

  • 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

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Interventions

BIOLOGICALFMT

FMT from healthy donor or placebo


Locations(1)

Helsinki University Hospital

Helsinki, Helsinki and Uusimaa, Finland

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NCT05361785


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