Faecal Microbiota Transplantation for Microscopic Colitis

NCT05998174 — Early Phase 1, Unknown, 20 participants, Hvidovre University Hospital

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT05998174
Status	Unknown
Phase	Early Phase 1
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	20 (Estimated)
Sponsor	Hvidovre University Hospital (Other)
Conditions	Microscopic Colitis
Interventions	Faecal Microbiota Transplantation (Other)
Dates	start 2023-09-01 (estimated), primary completion 2024-09-01 (estimated), completion 2025-03-01 (estimated), first posted 2023-08-18, last updated 2023-08-18

-Summary

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

Expand all sections · Collapse all

+Arms and interventions

Faecal Microbiota Transplantation (Other): treatment with capsules

+Outcome measures

Primary outcomes

Treatment effect [3 weeks]: Proportion of participants in remission

+Eligibility

Sex: All, ages: 18 Years to any

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