ClinicalTrials.gg
Not yet recruitingNCT05998174Updated Aug 18, 2023

Faecal Microbiota Transplantation for Microscopic Colitis

An Early Phase 1 interventional study of Faecal Microbiota Transplantation in Microscopic Colitis, sponsored by Hvidovre University Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-18.

Sponsored by Hvidovre University Hospital · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 2 months ago, but the record still lists the study as not yet recruiting.
Phase
Early Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Microscopic Colitis

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03

In context

Colitis, Microscopic

23 studies on the registry are indexed under Colitis, Microscopic; 6 are open to participants now.

This study's planned enrollment of 20 is below the median of 47 across 14 interventional studies indexed under Colitis, Microscopic.

Browse Colitis, Microscopic studies →

Lead sponsor

Hvidovre University Hospital is the lead sponsor of 299 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion 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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Interventions

  • OtherFaecal Microbiota Transplantation

    treatment with capsules

06

What researchers measure

Primary outcomes

  1. Treatment effect

    Proportion of participants in remission

    Time frame: 3 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05998174
Responsible party
Sigen Wildt (Consultant, MD, ph.d, Hvidovre University Hospital) — Principal investigator
First posted
Aug 18, 2023
Start date
Sep 2023 (estimated)
Primary completion
Sep 2024 (estimated)
Completion
Mar 2025 (estimated)
Last update
Aug 18, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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