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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 June 2016 |
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Main ID: |
NCT02391012 |
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Date of registration:
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05/03/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Fecal Transplantation for Inflammatory Bowel Disease
FMT IBD |
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Scientific title:
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Fecal Transplantation for Inflammatory Bowel Disease |
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Date of first enrolment:
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April 2015 |
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Target sample size:
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9 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02391012 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Israel
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Contacts
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Name:
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Timna Naftali, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Meir Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Signed informed consent
2. Inflammatory bowel disease diagnosed at least 3 months ago
3. Failure of either one immunomodulator of at least 3 months duration, or TNF inhibitor
full induction treatment, or intolerance to either of these drugs.
4. Currently active disease, partial Mayo score =4 for ulcerative colitis, or CDAI =200
for CD.
5. negative HIV , HTLV I/II, negative stool culture, Negative C diff toxin, negative CMV
Exclusion Criteria:
1. No informed consent
2. Non active inflammatory bowel disease.
3. Active infection in either the donor or the recipient,
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Inflammatory Bowel Disease
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Intervention(s)
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Biological: Fecal microbial l transplantation
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Primary Outcome(s)
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Improvement of disease activity index.
[Time Frame: 4 weeks]
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Secondary Outcome(s)
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improvement of endoscopic score
[Time Frame: 4 weeks]
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Patients perspective of the treatment (do patients regard the treatment as acceptable)
[Time Frame: 6 months]
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Cost estimation of the treatment
[Time Frame: 6 months]
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side effects (presence of fever,or rise of 50% or more in the number of bowel movements)
[Time Frame: 6 months]
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Maintenance of remission/ improvement during follow up
[Time Frame: 6 months]
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Secondary ID(s)
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0198-12-MMC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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