Faecal Microbiota Transplantation for Microscopic Colitis

Early Phase 1

Not yet recruiting

• Conditions: Microscopic Colitis

• Registration Number: NCT05998174
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

A pilot study investigating if orally administrated faecal microbiota transplantation capsules have the potential to treat active microscopic colitis.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-09
• Study First Submitted QC: 2023-08-09
• Last Update Submitted: 2023-08-09
• Study First Posted: 2023-08-18
• Last Update Posted: 2023-08-18
• Study Start: 2023-09
• Primary Completion: 2024-09
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Diagnosis of microscopic colitis
• Date of diagnosis/histological confirmation < 12 months
• Active disease according to Hjortswang's criteria

Exclusion Criteria

• Diagnosed with ulcerative colitis or Crohn's disease
• Diagnosed with celiac disease
• Active gastrointestinal infection
• Previous bowel resection of bowel (except appendectomy)
• Previous cholecystectomy
• Treatment with systemic steroid within 4 weeks, including budesonide
• Antibiotics 3 months prior
• Severe immunodeficiency,
• Pregnancy, planned pregnancy and breastfeeding
• Treatment with constipants such as psyllium, loperamide, bile binders, opium drops or codeine up to 2 weeks before inclusion and during participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Treatment effect	3 weeks	Proportion of participants in remission