Faecal Microbiota Transplantation for Microscopic Colitis

NCT ID: NCT05998174

Last Updated: 2023-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2025-03-31

Brief Summary

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

Conditions

Microscopic Colitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Faecal Microbiota Transplantation

treatment with capsules

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sigen Wildt

Consultant, MD, ph.d

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

FMT for MC

Identifier Type: -

Identifier Source: org_study_id