Microscopic ColitisEarly Phase 1NCT05998174
Faecal Microbiota Transplantation for Microscopic Colitis
A Early Phase 1 study testing Faecal Microbiota Transplantation in people with Microscopic Colitis, run by Hvidovre University Hospital.
Trial summary
A pilot study investigating if orally administrated faecal microbiota transplantation capsules have the potential to treat active microscopic colitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microscopic Colitis
- What is being tested?
- Faecal Microbiota Transplantation
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Mar 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of microscopic colitis
- Date of diagnosis/histological confirmation < 12 months
- Active disease according to Hjortswang's criteria
Who cannot join
- 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
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- 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
About this study
A pilot study investigating if orally administrated faecal microbiota transplantation capsules have the potential to treat active microscopic colitis.
- Conditions
- Microscopic Colitis
- Being tested
- Faecal Microbiota Transplantation
- Medical subject headings
- Colitis, Microscopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faecal Microbiota TransplantationOther
treatment with capsules
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment effect
Proportion of participants in remission
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study startSep 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microscopic ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- pilot trial
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sigen Wildt, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998174
- Sponsor's protocol ID
- FMT for MC
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faecal Microbiota Transplantation for Microscopic Colitis
- ClinicalTrials.gov ID
- NCT05998174
- Acronym / sponsor ID
- FMT for MC
- Conditions
- Microscopic Colitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pilot study investigating if orally administrated faecal microbiota transplantation capsules have the potential to treat active microscopic colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- pilot trial
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of microscopic colitis
- Date of diagnosis/histological confirmation < 12 months
- Active disease according to Hjortswang's criteria
Key exclusion criteria (10 listed)
- Diagnosed with ulcerative colitis or Crohn's disease
- Diagnosed with celiac disease
- Active gastrointestinal infection
- Previous bowel resection of bowel (except appendectomy)
- Previous cholecystectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Faecal Microbiota Transplantationtreatment with capsules | Other | – |
Primary outcome
Treatment effect
Time frame: 3 weeks
Proportion of participants in remission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Faecal Microbiota Transplantation in people with Microscopic Colitis, run by Hvidovre University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment effect (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.