Faecal Microbiota Transplantation for Microscopic Colitis NCT05998174

Updated 05/14/2024

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number	NCT05998174
Other study ID #	FMT for MC
Secondary ID
Status	Not yet recruiting
Phase	Early Phase 1
First received
Last updated
Start date	September 2023
Est. completion date	March 2025

Study information
Verified date	August 2023
Source	Hvidovre University Hospital
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status	Not yet recruiting
Enrollment	20
Est. completion date	March 2025
Est. primary completion date	September 2024
Accepts healthy volunteers	No
Gender	All
Age group	18 Years and older
Eligibility	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

Related Conditions & MeSH terms

Intervention

Other:
• Faecal Microbiota Transplantation
treatment with capsules

Locations
Country	Name	City	State
n/a

Sponsors *(1)*
Lead Sponsor	Collaborator
Hvidovre University Hospital

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Treatment effect	Proportion of participants in remission	3 weeks

See also
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