Fecal Microbiota TransplantationFMT-IBDNCT04436874
Fecal Microbiota Transplantation in the Treatment of Inflammatory Bowel Disease
A study testing endoscopy in people with Fecal Microbiota Transplantation, run by First Affiliated Hospital of Kunming Medical University at 1 site in China.
Trial summary
Fecal microbiota transplantation (FMT), defined as infusion of feces from healthy donors to affected subjects, is a method to restore a balanced gut microbiota and has attracted great interest in recent years due to its efficacy and ease of use. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Fecal Microbiota Transplantation
- What is being tested?
- endoscopy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2019to 23 Dec 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-75 years inclusive (no limit on gender)
- Confirmed diagnosis of ulcerative colitis for > 3 months, according to established clinical,endoscopic and histologic criteria
- Currently active mild-moderate ulcerative colitis, as measured by a Mayo score of 4-10, in which endoscopy sub-score ≥ 1 and physician's global assessment sub-score ≤ 2
- Written informed consent obtained.
Who cannot join
- Subjects who are unable to give consent or who have conditions rendering them incapable to answer questionnaires or provide samples.
- Females who are pregnant or actively trying to fall pregnant
- Subjects unwilling to practice an effective method of contraception throughout the study period
- Subjects defined as in remission by the investigator
- Evidence or history of toxic megacolon
- Isolated proctitis < 5 cm
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- A diagnosis of Crohn's Disease or indeterminate colitis
- Subjects with perianal disease (e.g. fistulae, pre-existing fissures)
- Significant gastrointestinal surgery e.g. colon resection, colectomy :Minor gastrointestinal surgery will be reviewed on a case by case basis by the investigator;Regarding appendicectomy, only exclude patients who had appendicectomy < 3 months ago)
- Subjects taking antimicrobials (antibiotics, antifungals, antivirals) for any reason, including antibiotics for ulcerative colitis, in the preceding 4 weeks
- Subjects who are steroid dependent and requiring > 20mg prednisone or > 9mg budesonide daily at the time of enrolment
- Subjects who have recently taken or are actively taking or expected to require prohibited medication/s during the study period including follow-up. These include:Rectal therapy including corticosteroid, 5-aminosalicylate within 2 weeks before first FMT;Treatment with biologic agents e.g. infliximab, adalimumab, vedolizumab, within 12 weeks before first FMT;Treatment with other major immunosuppressant agents including calcineurin inhibitors, anti-neoplastic agents, lymphocyte depleting biological agents within 12 weeks before first FMT;Probiotic therapy within 4 weeks before first FMT;Experimental / trial drug protocol involvement within 12 weeks before first FMT;Anti-mycobacterial (TB or MAC) therapy within 4 weeks before first FMT
- Allowed concomitant medications:
- The following drugs are allowed as long as the dose is stable preceding first FMT for the noted time:
- oral 5-aminosalicylates (stable dose for 4 weeks)
- thiopurines and methotrexate (on medication for ≥ 90 days and dose stable for 4 weeks)
- oral prednisolone (dose ≤ 20mg daily and stable for 2 weeks) During the study, subjects should remained on the same dose of oral 5-aminosalicylate, thiopurine, and methotrexate. For oral prednisolone, dose must be tapered at a rate up to 2.5mg per week so that subjects would be steroid-free by week 8.
- Prohibited medications:
- The following drugs for are prohibited for the noted time:
- Rectal therapies including corticosteroid, 5-aminosalicylate (for 2 weeks before first FMT and during study period)
- Antibiotics, antibiotics, antifungals, antivirals, probiotic or prebiotic preparations (for 4 weeks before first FMT and during study period)
- Rectal therapies including corticosteroid, 5-aminosalicylate (for 2 weeks before first FMT and during study period)
- Biological therapies or calcineurin inhibitors (for 12 weeks before first FMT and during study period)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fecal Microbiota Transplantation in the Treatment of Inflammatory Bowel Disease: the Role of Selection of the Dai Ethnic Group as Donor Source in Terms of Treatment Efficacy and Pathogenic Mechanisms
Fecal microbiota transplantation (FMT), defined as infusion of feces from healthy donors to affected subjects, is a method to restore a balanced gut microbiota and has attracted great interest in recent years due to its efficacy and ease of use.
Read the detailed description
FMT is now recommended as the most effective therapy for CDI not responding to standard therapies1.Recent studies have suggested that dysbiosis is associated with a variety of disorders, and that FMT could be a useful treatment. Randomized controlled trial has been conducted in a number of disorders including ulcerative colitis (UC). Our study is aims to Fecal microbiota transplantation in the treatment of Inflammatory Bowel Disease, the role of selection of the Dai ethnic group as donor source in terms of treatment efficacy and pathogenic mechanisms.
- Conditions
- Fecal Microbiota Transplantation
- Being tested
- endoscopy
- Keywords
- Ulcerative Colitis, Crohn's disease
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopyDevice
transplant infusion of feces from healthy donors into affected subjects
| Study group | Role | What they receive |
|---|---|---|
| Han ethnic-UC | Experimental | Ulcerative colitis subjects will be treated with bacterial solution from Han ethnic by endoscopy Receives: Device: endoscopy |
| Han ethnic-CD | Experimental | Crohn's disease subjects will be treated with bacterial solution from Han ethnic by endoscopy Receives: Device: endoscopy |
| Dai ethnic-UC | Experimental | Ulcerative colitis subjects will be treated with bacterial solution from Dai ethnic by endoscopy Receives: Device: endoscopy |
| Dai ethnic-CD | Experimental | Crohn's disease subjects will be treated with bacterial solution from Dai ethnic by endoscopy Receives: Device: endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
steroid-free clinical remission and endoscopic remission
The primary outcome is a composite of steroid-free clinical remission together with endoscopic remission or response at week 6, defined as defined as a total Mayo score of ≤2 points with no individual sub-score >1 point, and at least a 1 point reduction from baseline in the endoscopy sub-score
Measured: 3 years
Secondary outcomes (10)
Steroid-free clinical remission
defined as combined Mayo sub-scores of 1 or less for rectal bleeding plus stool frequency
Measured: 3 years
Steroid-free clinical response
defined as either a decrease of 3 points or more on the Mayo score, a 50% or greater reduction from baseline in combined rectal bleeding plus stool frequency Mayo sub-scores, or both
Measured: 3 years
Steroid-free endoscopic response
defined as a Mayo endoscopy sub-score of 1 or less, with a reduction of at least 1 point from baseline
Measured: 3 years
microbiological change
Changes in microbial composition (including bacteriome, virome and fungome), function and metabolite
Measured: 3 years
Change in microbiome of stool
Change in microbiome of stool (including bacteriome, virome and fungome)
Measured: 3 years
Difference in microbiome compared between subjects in different treatment arm
Difference in microbiome (including bacteriome, virome and fungome) compared between subjects in different treatment arm
Measured: 3 years
Proportion of microbiome
Proportion of microbiome (including bacteriome, virome and fungome) derived from recipient, donor or both in subjects who received FMT
Measured: 3 years
Difference in microbiome compared between subjects who have weight loss and those do not have weight loss
Difference in microbiome (including bacteriome, virome and fungome) compared between subjects who have weight loss and those do not have weight loss
Measured: 3 years
Microbial factors that are associated with percentage of body weight loss
Microbial factors (including bacteriome, virome and fungome) that are associated with percentage of body weight loss
Measured: 3 years
Trans-kingdom correlation of microbial engraftment after FMT between bacteriome, virome and fungome
Trans-kingdom correlation of microbial engraftment after FMT between bacteriome, virome and fungome
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start23 Sep 2019
- Primary completion23 Dec 2021 (estimated)
- Study completion23 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal Microbiota TransplantationStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Kunming Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Principal investigator, Yinglei Miao, First Affiliated Hospital of Kunming Medical University
- Investigators
- Y L Miao, doctor, Study director, First Affiliated Hospital of Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436874
- Sponsor's protocol ID
- FMT-IBD-190923
- Acronym
- FMT-IBD
- Status last verified
- Jun 2020
- First submitted
- 2 Jun 2020
- Last updated
- 19 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation in the Treatment of Inflammatory Bowel Disease: the Role of Selection of the Dai Ethnic Group as Donor Source in Terms of Treatment Efficacy and Pathogenic Mechanisms
- ClinicalTrials.gov ID
- NCT04436874
- Acronym / sponsor ID
- FMT-IBD / FMT-IBD-190923
- Conditions
- Fecal Microbiota Transplantation
- Keywords
- Ulcerative Colitis, Crohn's disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Kunming Medical UniversityUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 23 Dec 2021 (estimated)
- Study completion
- 23 Dec 2022 (estimated)
- First posted
- 18 Jun 2020 (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 microbiota transplantation (FMT), defined as infusion of feces from healthy donors to affected subjects, is a method to restore a balanced gut microbiota and has attracted great interest in recent years due to its efficacy and ease of use.
Detailed description
FMT is now recommended as the most effective therapy for CDI not responding to standard therapies1.Recent studies have suggested that dysbiosis is associated with a variety of disorders, and that FMT could be a useful treatment. Randomized controlled trial has been conducted in a number of disorders including ulcerative colitis (UC). Our study is aims to Fecal microbiota transplantation in the treatment of Inflammatory Bowel Disease, the role of selection of the Dai ethnic group as donor source in terms of treatment efficacy and pathogenic mechanisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Han ethnic-UC | Experimental | Device: endoscopyUlcerative colitis subjects will be treated with bacterial solution from Han ethnic by endoscopy |
| Han ethnic-CD | Experimental | Device: endoscopyCrohn's disease subjects will be treated with bacterial solution from Han ethnic by endoscopy |
| Dai ethnic-UC | Experimental | Device: endoscopyUlcerative colitis subjects will be treated with bacterial solution from Dai ethnic by endoscopy |
| Dai ethnic-CD | Experimental | Device: endoscopyCrohn's disease subjects will be treated with bacterial solution from Dai ethnic by endoscopy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-75 years inclusive (no limit on gender)
- Confirmed diagnosis of ulcerative colitis for > 3 months, according to established clinical,endoscopic and histologic criteria
- Currently active mild-moderate ulcerative colitis, as measured by a Mayo score of 4-10, in which endoscopy sub-score ≥ 1 and physician's global assessment sub-score ≤ 2
- Written informed consent obtained.
Key exclusion criteria (23 listed)
- Subjects who are unable to give consent or who have conditions rendering them incapable to answer questionnaires or provide samples.
- Females who are pregnant or actively trying to fall pregnant
- Subjects unwilling to practice an effective method of contraception throughout the study period
- Subjects defined as in remission by the investigator
- Evidence or history of toxic megacolon
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 |
|---|---|---|
| endoscopytransplant infusion of feces from healthy donors into affected subjects | Device | Dai ethnic-CD, Dai ethnic-UC, Han ethnic-CD, Han ethnic-UC |
Primary outcome
steroid-free clinical remission and endoscopic remission
Time frame: 3 years
The primary outcome is a composite of steroid-free clinical remission together with endoscopic remission or response at week 6, defined as defined as a total Mayo score of ≤2 points with no individual sub-score >1 point, and at least a 1 point reduction from baseline in the endoscopy sub-score
10 secondary outcomes
Steroid-free clinical remission
Time frame: 3 years
Steroid-free clinical response
Time frame: 3 years
Steroid-free endoscopic response
Time frame: 3 years
microbiological change
Time frame: 3 years
Change in microbiome of stool
Time frame: 3 years
Difference in microbiome compared between subjects in different treatment arm
Time frame: 3 years
Proportion of microbiome
Time frame: 3 years
Difference in microbiome compared between subjects who have weight loss and those do not have weight loss
Time frame: 3 years
Microbial factors that are associated with percentage of body weight loss
Time frame: 3 years
Trans-kingdom correlation of microbial engraftment after FMT between bacteriome, virome and fungome
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
- 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.
Y L Miao, doctor study director
First Affiliated Hospital of Kunming Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopy in people with Fecal Microbiota Transplantation, run by First Affiliated Hospital of Kunming Medical University at 1 site in China.
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 4 inclusion and 23 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 19 Jun 2020. 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 China. 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?
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?
steroid-free clinical remission and endoscopic remission (time frame: 3 years). 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 19 Jun 2020.