Ulcerative ColitisFMT-CUNCT03561532
Fecal Transplantation in Ulcerative Colitis
A study testing Fecal microbiota transplantation (FMT) in people with Ulcerative Colitis, run by Joint Authority for Päijät-Häme Social and Health Care at 2 sites in Finland.
Trial summary
Adult individuals with ulcerative colitis in remission are given a single fecal microbiota transplantation (FMT) in colonoscopy. A half of the patients will receive autologous FMT as a placebo and a half will receive an FMT from a healthy donor. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Fecal microbiota transplantation (FMT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesFinland
- Study dates
- 1 Oct 2016to 31 May 2020
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • • Diagnosis of CU based on clinical, endoscopic, and histological findings.
- Remission assessed by Mayo score (0 to 1) and F-Calpro (<100 ug/g).
- Availability of consecutive fecal samples during one year after the diagnosis of CU.
- Availability of blood sample to study the IBD associated genetic background
- Compliance to attend ileocolonoscopy and FMT within 3-6 months after the diagnosis of CU and at 52 week
- 18-75 years
Who cannot join
- Unable to provide informed consent
- Need for any antibiotic therapy within 3 months
- Use of corticosteroids, immunosuppressive or biological medication at the baseline
- Use of any probiotics
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Helsinki University Hospital
Helsinki
Päijät-Häme Central Hospital
Lahti
About this study
Official title: FECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF ULCERATIVE COLITIS
Adult individuals with ulcerative colitis in remission are given a single fecal microbiota transplantation (FMT) in colonoscopy. A half of the patients will receive autologous FMT as a placebo and a half will receive an FMT from a healthy donor.
Read the detailed description
80 adult patients with ulcerative colitis (UC) will be recruited. They are randomized to receive either an autologous FMT as a placebo or FMT from a healthy donor (frozen and thawed).
The patients are followed up with fecal samples to detect microbial changes. The follow up lasts 1 year after the FMT and a follow up colonoscopy will be done 52 weeks after the FMT.
- Conditions
- Ulcerative Colitis
- Being tested
- Fecal microbiota transplantation (FMT), Placebo
- 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 (FMT)Other
FMT administered into the cecum of the patient in colonoscopy.
PlaceboOther
Autologous FMT (fecal suspension made of patients own feces) administered into the cecum of the patient in colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| FMT | Active comparator | 50% of the participants will receive fecal suspension of a healthy donor administered in colonoscopy into the cecum Receives: Other: Fecal microbiota transplantation (FMT) |
| Placebo | Placebo comparator | 50% of the participants will receive fecal suspension made of their own feces administered in colonoscopy into the cecum. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of remission of ulcerative colitis
Endoscopic remission and Mayo-score < 2
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start1 Oct 2016
- Primary completion31 May 2020 (estimated)
- Study completion31 May 2020 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized in two groups to receive in colonoscopy either a fecal suspension made of their own feces or a fecal suspension of a healthy donor.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joint Authority for Päijät-Häme Social and Health Care
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, University of Helsinki
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561532
- Sponsor's protocol ID
- HUS / 1652/2016
- Acronym
- FMT-CU
- Status last verified
- Aug 2019
- First submitted
- 6 Jun 2018
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF ULCERATIVE COLITIS
- ClinicalTrials.gov ID
- NCT03561532
- Acronym / sponsor ID
- FMT-CU / HUS / 1652/2016
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Joint Authority for Päijät-Häme Social and Health CareUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, University of Helsinki
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 19 Jun 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.
Adult individuals with ulcerative colitis in remission are given a single fecal microbiota transplantation (FMT) in colonoscopy. A half of the patients will receive autologous FMT as a placebo and a half will receive an FMT from a healthy donor.
Detailed description
80 adult patients with ulcerative colitis (UC) will be recruited. They are randomized to receive either an autologous FMT as a placebo or FMT from a healthy donor (frozen and thawed).
The patients are followed up with fecal samples to detect microbial changes. The follow up lasts 1 year after the FMT and a follow up colonoscopy will be done 52 weeks after the FMT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized in two groups to receive in colonoscopy either a fecal suspension made of their own feces or a fecal suspension of a healthy donor.
| Arm | Type | Receives |
|---|---|---|
| FMT | Active comparator | Other: Fecal microbiota transplantation (FMT)50% of the participants will receive fecal suspension of a healthy donor administered in colonoscopy into the cecum |
| Placebo | Placebo comparator | Other: Placebo50% of the participants will receive fecal suspension made of their own feces administered in colonoscopy into the cecum. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • • Diagnosis of CU based on clinical, endoscopic, and histological findings.
Key exclusion criteria (5 listed)
- Unable to provide informed consent
- Need for any antibiotic therapy within 3 months
- Use of corticosteroids, immunosuppressive or biological medication at the baseline
- Use of any probiotics
- Pregnancy
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 (FMT)FMT administered into the cecum of the patient in colonoscopy. | Other | FMT |
| PlaceboAutologous FMT (fecal suspension made of patients own feces) administered into the cecum of the patient in colonoscopy. | Other | Placebo |
Primary outcome
Maintenance of remission of ulcerative colitis
Time frame: 52 weeks
Endoscopic remission and Mayo-score < 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal microbiota transplantation (FMT) in people with Ulcerative Colitis, run by Joint Authority for Päijät-Häme Social and Health Care at 2 sites in Finland.
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 6 inclusion and 5 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 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Maintenance of remission of ulcerative colitis (time frame: 52 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 15 Aug 2019.