Faecal Microbiota Transplantation for Microscopic Colitis

Microscopic Colitis Clinical Trial

Official title:

Faecal Microbiota Transplantation for Microscopic Colitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05998174
• Other study ID #: FMT for MC
• Status: Not yet recruiting
• Phase: Early Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Colitis
• Colitis, Microscopic
• Microscopic Colitis

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