Ulcerative ColitisPhase 1/2NCT03711006
The Effect of Fecal Microbiota Transplantation in Ulcerative Colitis
A Phase 1/2 study testing Fecal Microbiota Transplantation Capsules in people with Ulcerative Colitis, run by Alice Højer Christensen at 1 site in Denmark.
Trial summary
7 patients with active Ulcerative Colitis are treated with 25 multi-donor FMT Capsules daily for 50 days. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Fecal Microbiota Transplantation Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2017to 30 Nov 2017
- Phase
- Phase 1/2
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with Ulcerative Colitis (UC)
- SCCAI between 4 and 10 at inclusion
- On a stable dose of 5-aminosalicylic acid (5-ASA) or without current treatment.
- Previous treatment with glucocorticoids, thiopurines and/or biological treatment was accepted.
- Fecal Calprotectin > 250 mg/kg
- Colonoscopy performed within the last 3 years
- Capable of writing and speaking Danish
- Attending regular follow-ups by a specialist in gastroenterology.
Who cannot join
- Biological treatment within the last four weeks
- Treatment with antibiotics within 48 hours before intervention
- Alcohol use above current Danish guidelines (14 units/week for men and 7 units/week for women)
- Pregnancy or planned pregnancy
- Active cancer disease
- Medical treatment of mental disorder
- Other chronic gastroenterological disorder besides UC, Irritable Bowel Syndrome (IBS) or Reflux-disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Fecal Microbiota Transplantation in Ulcerative Colitis - A Case Study
7 patients with active Ulcerative Colitis are treated with 25 multi-donor FMT Capsules daily for 50 days.
Read the detailed description
7 patients with active Ulcerative Colitis are treated with 25 multi-donor FMT Capsules daily for 50 days All patients are followed with regular follow up after 2,4,8,12,16, 20 and 24 weeks.
- Conditions
- Ulcerative Colitis
- Being tested
- Fecal Microbiota Transplantation Capsules
- Keywords
- Fecal Microbiota Transplantation
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota Transplantation CapsulesOther
Also called FMT Capsules
25 daily multi-donor FMT Capsules for 50 days
| Study group | Role | What they receive |
|---|---|---|
| FMT treated patients | Experimental | Seven patients with active Ulcerative Colitis treated with 25 multi-donor FMT Capsules daily. Receives: Other: Fecal Microbiota Transplantation Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient colitis symptoms as assessed using the Simple Colitis Clinical Activity Index (SCCAI)
Simple Colitis Clinical Activity Index (SCCAI)
Measured: Baseline, 2,8,16 and 24 weeks
Secondary outcomes (5)
Fecal microbiota biodiversity in patients with Ulcerative Colitis and difference to donors fecal microbiota diversity
Alpha diversity (Shannon-index)
Measured: Baseline
Fecal microbiota biodiversity in fecal donors
Alpha diversity (Shannon-index)
Measured: At donor inclusion
Changes in fecal microbiota biodiversity in patients with Ulcerative Colitis in comparison with value at baseline
Alpha diversity (Shannon-index)
Measured: 8, 16 and 24 weeks
Changes in Fecal Calprotectin in the active treatment period and follow-up period
Fecal Calprotectin
Measured: Baseline, 8,16 and 24 weeks
Changes in patient reported quality of life: IBDQ
Inflammatory Bowel Disease Questionnaire (IBDQ)
Measured: Baseline, 8, 16 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start1 Feb 2017
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The trial is an open-label pilot study treating 7 patients with Ulcerative Colitis with 25 daily multi-donor FMT Capsules for 50 days with 6 months follow up including the treatment period
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alice Højer Christensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alice Højer Christensen, Aleris-Hamlet Hospitaler København
- Investigators
- Alice H Christensen, MD, PhD, Principal investigator, Aleris-Hamlet Hospitals Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711006
- Sponsor's protocol ID
- 16049117
- Status last verified
- Oct 2018
- First submitted
- 10 Oct 2018
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are available upon request
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fecal Microbiota Transplantation in Ulcerative Colitis - A Case Study
- ClinicalTrials.gov ID
- NCT03711006
- Acronym / sponsor ID
- 16049117
- Conditions
- Ulcerative Colitis
- Keywords
- Fecal Microbiota Transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Alice Højer ChristensenUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 18 Oct 2018 (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.
7 patients with active Ulcerative Colitis are treated with 25 multi-donor FMT Capsules daily for 50 days.
Detailed description
7 patients with active Ulcerative Colitis are treated with 25 multi-donor FMT Capsules daily for 50 days All patients are followed with regular follow up after 2,4,8,12,16, 20 and 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The trial is an open-label pilot study treating 7 patients with Ulcerative Colitis with 25 daily multi-donor FMT Capsules for 50 days with 6 months follow up including the treatment period
| Arm | Type | Receives |
|---|---|---|
| FMT treated patients | Experimental | Other: Fecal Microbiota Transplantation CapsulesSeven patients with active Ulcerative Colitis treated with 25 multi-donor FMT Capsules daily. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Diagnosed with Ulcerative Colitis (UC)
- SCCAI between 4 and 10 at inclusion
- On a stable dose of 5-aminosalicylic acid (5-ASA) or without current treatment.
- Previous treatment with glucocorticoids, thiopurines and/or biological treatment was accepted.
- Fecal Calprotectin > 250 mg/kg
Key exclusion criteria (7 listed)
- Biological treatment within the last four weeks
- Treatment with antibiotics within 48 hours before intervention
- Alcohol use above current Danish guidelines (14 units/week for men and 7 units/week for women)
- Pregnancy or planned pregnancy
- Active cancer disease
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 |
|---|---|---|
| Fecal Microbiota Transplantation CapsulesAlso: FMT Capsules25 daily multi-donor FMT Capsules for 50 days | Other | FMT treated patients |
Primary outcome
Change in patient colitis symptoms as assessed using the Simple Colitis Clinical Activity Index (SCCAI)
Time frame: Baseline, 2,8,16 and 24 weeks
Simple Colitis Clinical Activity Index (SCCAI)
5 secondary outcomes
Fecal microbiota biodiversity in patients with Ulcerative Colitis and difference to donors fecal microbiota diversity
Time frame: Baseline
Fecal microbiota biodiversity in fecal donors
Time frame: At donor inclusion
Changes in fecal microbiota biodiversity in patients with Ulcerative Colitis in comparison with value at baseline
Time frame: 8, 16 and 24 weeks
Changes in Fecal Calprotectin in the active treatment period and follow-up period
Time frame: Baseline, 8,16 and 24 weeks
Changes in patient reported quality of life: IBDQ
Time frame: Baseline, 8, 16 and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
- Individual participant dataSharing planned: No. Data are available upon request
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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.
Alice H Christensen, MD, PhD principal investigator
Aleris-Hamlet Hospitals Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fecal Microbiota Transplantation Capsules in people with Ulcerative Colitis, run by Alice Højer Christensen at 1 site in Denmark.
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 8 inclusion and 7 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: finished, as of the sponsor's last update on 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in patient colitis symptoms as assessed using the Simple Colitis Clinical Activity Index (SCCAI) (time frame: Baseline, 2,8,16 and 24 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 Oct 2018.