Inflammatory Bowel DiseasePhase 2SFMT-IBDNCT02335281
Standardized Fecal Microbiota Transplantation for Inflammatory Bowel Disease
A Phase 2 study testing FMT and Mesalazine in people with Inflammatory Bowel Disease and Ulcerative Colitis, run by Yanling Wei at 1 site in China.
Trial summary
There are many limitations in the current treatments of Inflammatory bowel disease (IBD). Now the investigators realized that the intestinal microecological is closely associated with the development of IBD. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Inflammatory Bowel Disease, Ulcerative Colitis, Crohn's Disease
- What is being tested?
- FMT and Mesalazine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Dec 2017
- Phase
- Phase 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Severe IBD define as HBI score ≥ 9.
- Moderate IBD define as 7<HBI <9
- Montreal classification: Age > 14 years old, Location L1-3, Behavior B1-3.
Who cannot join
- Diarrhea activity scores < 3
- Severely active disease with perianal diseases
- Severely active disease with indication of surgery.
- Diagnosis as IBD first time or first year.
- No history of using 5-ASA, biological (antibody), immunomodulatory therapy, corticosteroid therapy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, Research Institute of Surgery, Da ping Hospital, The Third Military Medical University
Chongqing, Chongqing Municipality, 400042
Dongfeng Chen, doctor, 86-13883032812, chendf1981@126.com
Yanling Wei, doctor, 86-15310354666, lingzi016@126.com
About this study
Official title: Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation for Severe Inflammatory Bowel Disease
There are many limitations in the current treatments of Inflammatory bowel disease (IBD). Now the investigators realized that the intestinal microecological is closely associated with the development of IBD. So the standardized fecal microbiota transplantation is considered to be simple but effective emerging therapies for the treatment of IBD. In this project the investigators intend to carry out a single-center, randomized, single-blind clinical intervention study. The investigators will recruit 40 patients with IBD (20 cases of Ulcerative Colitis and 20 cases of Crohn's disease) in China. The patients will be randomly divided into 2 groups, one group will be given treatment of standardized fecal microbiota transplantation, the other will be simply treated with mesalazine, followed up for at least 1 year. The investigators propose to determine the efficiency, durability and safety of Standardized Fecal Microbiota Transplantation for IBD treatment.
Read the detailed description
In this projects the investigators aim to re-establish a gut balance of intestinal microecological through Standardized Fecal Microbiota Transplantation for IBD (UC and CD). We will establish a standardized isolation, store, and transportion steps of fecal bacteria from donated fresh stool in the laboratory. Then the bacteria will be transplanted to mid-gut by nose-jejunum nutrition tube. Patients in this study will be assigned to receive standardized FMT only once or traditional medicine of mesalazine and would be followed up for at least 1 year. The clinical symptoms, sign, blood tests, abdominal CT, endoscopy and questionnaire will be used to assess the efficiency, durability and safety of Standardized FMT at the start and end of the projects.
- Being tested
- FMT, Mesalazine
- Keywords
- Standardized Fecal Microbiota Transplantation, Inflammatory Bowel Disease, Ulcerative Colitis, Crohn's Disease
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMTProcedure or surgery
Standardized FMT once
MesalazineDrug
Also called Mesalamine
2g Po perday
| Study group | Role | What they receive |
|---|---|---|
| Standardized FMT | Experimental | The group include 20 patients. They will receive standardized FMT. The FMT was given to mid-gut by nose-jejunum nutrition tube. It was given only once. Receives: Procedure: FMT |
| Mesalazine | Active comparator | This group include 20 patients . The patients will receive traditional medicine of mesalazine treatment. Receives: Drug: Mesalazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission (defined as HBI score ≦ 4)
Clinical remission defined as HBI score ≦ 4. The endpoint of follow-up is the time of clinical recurrence
Measured: up to one year
Secondary outcomes (1)
Hospitalization days
Hospitalization days from administration to discharge when at clinical remission.
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanling Wei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanling Wei, Third Military Medical University
- Investigators
- Dongfeng Chen, doctor, Study director, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335281
- Sponsor's protocol ID
- TMMU-DP-GI-FMT-001
- Acronym
- SFMT-IBD
- Status last verified
- Jan 2015
- First submitted
- 7 Jan 2015
- Last updated
- 9 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation for Severe Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT02335281
- Acronym / sponsor ID
- SFMT-IBD / TMMU-DP-GI-FMT-001
- Keywords
- Standardized Fecal Microbiota Transplantation, Inflammatory Bowel Disease, Ulcerative Colitis, Crohn's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yanling WeiUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 9 Jan 2015 (estimated)
- 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.
There are many limitations in the current treatments of Inflammatory bowel disease (IBD). Now the investigators realized that the intestinal microecological is closely associated with the development of IBD. So the standardized fecal microbiota transplantation is considered to be simple but effective emerging therapies for the treatment of IBD. In this project the investigators intend to carry out a single-center, randomized, single-blind clinical intervention study. The investigators will recruit 40 patients with IBD (20 cases of Ulcerative Colitis and 20 cases of Crohn's disease) in China. The patients will be randomly divided into 2 groups, one group will be given treatment of standardized fecal microbiota transplantation, the other will be simply treated with mesalazine, followed up for at least 1 year. The investigators propose to determine the efficiency, durability and safety of Standardized Fecal Microbiota Transplantation for IBD treatment.
Detailed description
In this projects the investigators aim to re-establish a gut balance of intestinal microecological through Standardized Fecal Microbiota Transplantation for IBD (UC and CD). We will establish a standardized isolation, store, and transportion steps of fecal bacteria from donated fresh stool in the laboratory. Then the bacteria will be transplanted to mid-gut by nose-jejunum nutrition tube. Patients in this study will be assigned to receive standardized FMT only once or traditional medicine of mesalazine and would be followed up for at least 1 year. The clinical symptoms, sign, blood tests, abdominal CT, endoscopy and questionnaire will be used to assess the efficiency, durability and safety of Standardized FMT at the start and end of the projects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized FMT | Experimental | Procedure: FMTThe group include 20 patients. They will receive standardized FMT. The FMT was given to mid-gut by nose-jejunum nutrition tube. It was given only once. |
| Mesalazine | Active comparator | Drug: MesalazineThis group include 20 patients . The patients will receive traditional medicine of mesalazine treatment. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Severe IBD define as HBI score ≥ 9.
- Moderate IBD define as 7<HBI <9
- Montreal classification: Age > 14 years old, Location L1-3, Behavior B1-3.
Key exclusion criteria (5 listed)
- Diarrhea activity scores < 3
- Severely active disease with perianal diseases
- Severely active disease with indication of surgery.
- Diagnosis as IBD first time or first year.
- No history of using 5-ASA, biological (antibody), immunomodulatory therapy, corticosteroid therapy
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 |
|---|---|---|
| FMTStandardized FMT once | Procedure or surgery | Standardized FMT |
| MesalazineAlso: Mesalamine2g Po perday | Drug | Mesalazine |
Primary outcome
Clinical remission (defined as HBI score ≦ 4)
Time frame: up to one year
Clinical remission defined as HBI score ≦ 4. The endpoint of follow-up is the time of clinical recurrence
1 secondary outcome
Hospitalization days
Time frame: up to one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2015.
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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.
Dongfeng Chen, doctor study director
Third Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FMT and Mesalazine in people with Inflammatory Bowel Disease and Ulcerative Colitis, run by Yanling Wei 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 3 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 9 Jan 2015. 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.
What does this phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dongfeng Chen, doctor (86-13883032812, chedf1981@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission (defined as HBI score ≦ 4) (time frame: up to one year). 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 9 Jan 2015.