NCT05998174

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Sep 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

August 9, 2023

Last Update Submit

August 9, 2023

Conditions

Microscopic Colitis

Outcome Measures

Primary Outcomes (1)

  • Treatment effect

    Proportion of participants in remission

    3 weeks

Interventions

Faecal Microbiota TransplantationOTHER

treatment with capsules

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colitis, Microscopic

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: pilot trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, MD, ph.d

Study Record Dates

First Submitted

August 9, 2023

First Posted

August 18, 2023

Study Start

September 1, 2023

Primary Completion

September 1, 2024

Study Completion

March 1, 2025

Last Updated

August 18, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share