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Search / Trial NCT05361785

Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance

Launched by HELSINKI UNIVERSITY CENTRAL HOSPITAL · Apr 30, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Fmt Ibs Fodmap

ClinConnect Summary

This clinical trial is studying whether a procedure called fecal microbiota transplantation (FMT) can help people with irritable bowel syndrome (IBS) improve their ability to eat a wider variety of foods without causing more stomach problems. FMT involves transferring healthy bacteria from a donor's stool into the patient's gut, which may help balance the gut microbiome and ease IBS symptoms. This study aims to see if patients can extend their diet, particularly foods that are high in FODMAPs (certain types of carbohydrates that some people have trouble digesting), without feeling worse.

To participate in this trial, individuals must be adults aged 18 to 75 who speak Finnish and have been diagnosed with IBS based on specific criteria. Participants should currently be following a low FODMAP diet to manage their symptoms. However, those with certain health issues or who have recently taken antibiotics are not eligible. If you join the study, you can expect to undergo the FMT procedure and be monitored for any changes in your symptoms and dietary habits. This research is important because it could help improve treatment options for those struggling with IBS and food intolerances.

Gender

ALL

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

About Helsinki University Central Hospital

Helsinki University Central Hospital (HUCH) is a leading academic medical institution in Finland, dedicated to advancing healthcare through innovative research and clinical excellence. As a pivotal sponsor of clinical trials, HUCH integrates cutting-edge medical practices with rigorous scientific inquiry, fostering collaborations between researchers, healthcare professionals, and patients. The hospital is committed to enhancing patient outcomes and contributing to the global body of medical knowledge by conducting high-quality, ethically sound clinical studies across a diverse range of therapeutic areas. With a strong emphasis on education and training, HUCH plays a vital role in shaping the next generation of healthcare leaders and researchers.

Locations

Helsinki, Helsinki And Uusimaa, Finland

Patients applied

0 patients applied

Trial Officials

Perttu Arkkila, Professor

Principal Investigator

Head physician

Perttu Lahtinen, Md.

Study Chair

Head physician

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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