Inflammatory Bowel DiseasesNCT03399188
Fecal Microbiota Transplantation and Analysis of Fecal Microbiome in IBD Patients
A study testing Fecal microbiome transplantation in people with Inflammatory Bowel Diseases, run by Yonsei University at 1 site in South Korea.
Trial summary
Fecal microbiome of donor and recipient will be analyzed before and after fecal microbiota transplantation in IBD patients. Read more about this study
- Who is it for?
- Ages 7 to 80 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Fecal microbiome transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Nov 2017to 31 Dec 2023
- 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 7 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 7 years old to 80 years old at start of trial
- Inflammatory bowel disease such as ulcerative colitis, Crohn's disease, and Behcet's colitis
- Patients who do not respond to the conventional treatments or who do not wish/not able to use one.
- Patients who agree to participate in the trial after thorough explanation
- Evidence of active disease
Who cannot join
- Patients whose CRP<8, calprotectin<200, and mucosal healing endoscopically (who are in stable state)
- Patients whose symptom is due to other disease than IBD
- Patients with immunosuppressive disease
- Patients who are clinically unstable such as massive hemorrhage or perforation
- Patients with toxic megacolon, paralytic ileus, or symptomatic intestinal obstruction
- Absolute neutrophil count (ANC) <1.5 *10^9/L (1500/mm3)
- Pregnant or under breast feeding
- Patients enrolled in other clinical trials
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance hospital
Seoul, 03722
Hong Koh, 82-2-2227-2050, khong@yuhs.ac
About this study
Fecal microbiome of donor and recipient will be analyzed before and after fecal microbiota transplantation in IBD patients.
Read the detailed description
Fecal microbiota transplantation will be performed to the IBD patients, and microbial analysis will be done for donor and recipient feces. Fecal microbiota transplantation will be done twice via colonoscopy, with one month of duration. During the early stage of Fecal microbiota transplantation, recipient feces will be analyzed for the intestinal microbiota frequently.
Clinical outcome will be assessed 1month, 2month, 6month, and 1 year after the transplantation.
Relevance of intestinal microbial change and clinical outcome after transplantation and factors associated with successful clinical outcome will be investigated.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Fecal microbiome transplantation
- Keywords
- Inflammatory Bowel Diseases, Fecal microbiota transplantation, microbiome
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiome transplantationProcedure or surgery
Fecal microbiota transplantation will be performed through colonoscopy to the IBD patients. Donor feces will be extensively screened for other diseases. Colonoscopy will be done at FMT center of Severance Children's Hospital twice with a month of duration. Recipients will be admitted the day before colonoscopy, and they will be discharged after a day of observation.
| Study group | Role | What they receive |
|---|---|---|
| FMT group | Experimental | Group who received fecal microbiome transplantation Receives: Procedure: Fecal microbiome transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission
For Ulcerative Colitis patients Patients 18 years old and under: Pediatric ulcerative colitis activity index (PUCAI) less than 10.
It ranges from 0 to 85, with a higher score indicating greater severity of disease Patients over 18 years old: Partial Mayo score same or less than 1 It ranges from 0 to 9, with a higher score indicating greater severity of disease For Crohn's Disease patients Patients 18 years old and under: Pediatric Crohn's disease activity index (PCDAI) less than 10 It ranges from 0 to 100, with a higher score indicating greater severity of disease Patients over 18 years old: Crohn's disease activity index (CDAI) less than 150 It ranges from 0 to over 600, with a higher score indicating greater severity of disease
Measured: 6months after the Second FMT
Secondary outcomes (4)
Microbiome analysis by using relative abundance at phylum and genus level, beta diversity
- Microbial changes (increase of microbial diversity and improvement of firmicutes/bacteriodes ratio) in an early stage after FMT by using Relative abundance at phylum and genus level
- Microbial stability after FMT for one week (change in beta diversity)
Measured: Before, day 0~28 of 1st FMT, day 0~28, 60, 90, 180 of 2nd FMT
Clinical response using disease activity index
Measured: 6 months after the Second FMT
Endoscopic healing
Measured: 4 weeks after the First FMT
Adverse events
Any adverse events thought to be related to FMT will be measured throughout the follow-up period after FMT.
Measured: 6 months after the Second FMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start15 Nov 2017
- Primary completion30 Nov 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Inflammatory bowel disease patients in active stage.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399188
- Sponsor's protocol ID
- 4-2017-0223
- Status last verified
- Jan 2019
- First submitted
- 18 Dec 2017
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation and Analysis of Fecal Microbiome in IBD Patients
- ClinicalTrials.gov ID
- NCT03399188
- Acronym / sponsor ID
- 4-2017-0223
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Inflammatory Bowel Diseases, Fecal microbiota transplantation, microbiome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 16 Jan 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.
Fecal microbiome of donor and recipient will be analyzed before and after fecal microbiota transplantation in IBD patients.
Detailed description
Fecal microbiota transplantation will be performed to the IBD patients, and microbial analysis will be done for donor and recipient feces. Fecal microbiota transplantation will be done twice via colonoscopy, with one month of duration. During the early stage of Fecal microbiota transplantation, recipient feces will be analyzed for the intestinal microbiota frequently.
Clinical outcome will be assessed 1month, 2month, 6month, and 1 year after the transplantation.
Relevance of intestinal microbial change and clinical outcome after transplantation and factors associated with successful clinical outcome will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Inflammatory bowel disease patients in active stage.
| Arm | Type | Receives |
|---|---|---|
| FMT group | Experimental | Procedure: Fecal microbiome transplantationGroup who received fecal microbiome transplantation |
Who may qualify
- Ages
- 7 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 7 years old to 80 years old at start of trial
- Inflammatory bowel disease such as ulcerative colitis, Crohn's disease, and Behcet's colitis
- Patients who do not respond to the conventional treatments or who do not wish/not able to use one.
- Patients who agree to participate in the trial after thorough explanation
- Evidence of active disease
Key exclusion criteria (8 listed)
- Patients whose CRP<8, calprotectin<200, and mucosal healing endoscopically (who are in stable state)
- Patients whose symptom is due to other disease than IBD
- Patients with immunosuppressive disease
- Patients who are clinically unstable such as massive hemorrhage or perforation
- Patients with toxic megacolon, paralytic ileus, or symptomatic intestinal obstruction
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 microbiome transplantationFecal microbiota transplantation will be performed through colonoscopy to the IBD patients. Donor feces will be extensively screened for other diseases. Colonoscopy will be done at FMT center of Severance Children's Hospital twice with a month of duration. Recipients will be admitted the day before colonoscopy, and they will be discharged after a day of observation. | Procedure or surgery | FMT group |
Primary outcome
Clinical remission
Time frame: 6months after the Second FMT
For Ulcerative Colitis patients Patients 18 years old and under: Pediatric ulcerative colitis activity index (PUCAI) less than 10. It ranges from 0 to 85, with a higher score indicating greater severity of disease Patients over 18 years old: Partial Mayo score same or less than 1 It ranges from 0 to 9, with a higher score indicating greater severity of disease For Crohn's Disease patients Patients 18 years old and under: Pediatric Crohn's disease activity index (PCDAI) less than 10 It ranges from 0 to 100, with a higher score indicating greater severity of disease Patients over 18 years old: Crohn's disease activity index (CDAI) less than 150 It ranges from 0 to over 600, with a higher score indicating greater severity of disease
4 secondary outcomes
Microbiome analysis by using relative abundance at phylum and genus level, beta diversity
Time frame: Before, day 0~28 of 1st FMT, day 0~28, 60, 90, 180 of 2nd FMT
Clinical response using disease activity index
Time frame: 6 months after the Second FMT
Endoscopic healing
Time frame: 4 weeks after the First FMT
Adverse events
Time frame: 6 months after the Second FMT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal microbiome transplantation in people with Inflammatory Bowel Diseases, run by Yonsei University at 1 site in South Korea.
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 5 inclusion and 8 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 16 Jan 2019. 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 South Korea. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission (time frame: 6months after the Second FMT). 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 16 Jan 2019.