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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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26 October 2015 |
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Main ID: |
NCT02575040 |
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Date of registration:
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06/10/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of Fecal Microbiota Transplantation for Inflammatory Bowel Disease
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Scientific title:
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Efficacy of Fecal Microbiota Transplantation for Refractory Inflammatory Bowel Disease |
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Date of first enrolment:
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May 2015 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02575040 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Turkey
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Contacts
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Name:
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Hakan Demirci, M.D. |
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Address:
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Telephone:
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00905325140028 |
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Email:
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hakandemircigata@yahoo.com |
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Affiliation:
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Name:
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Hakan Demirci, M.D. |
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Address:
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Telephone:
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00905325140028 |
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Email:
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hakandemircigata@yahoo.com |
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Affiliation:
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Name:
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Ahmet Uygun, Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gulhane Military Medical Academy, Department of Gastroenterology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Signed informed consent
- Inflammatory bowel disease diagnosed at least 6 months ago
- Failure of either one immunomodulator of at least 3 months duration, or TNF inhibitor
full induction treatment, or corticosteroids, or intolerance to either of these
drugs.
- Currently active disease, partial Mayo score =4 for ulcerative colitis, or CDAI =200
for CD.
- negative HIV , Human T-cell leukemia virus I/II, negative stool culture, Negative C
diff toxin, negative Cytomegalovirus
Exclusion Criteria:
- No informed consent
- Non active inflammatory bowel disease.
- Active infection in either the donor or the recipient,
- Response to biological agents
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Constipation (Excl Faecal Impaction)
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Crohn Disease
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Intervention(s)
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Biological: Fecal microbiota transplantation
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Primary Outcome(s)
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Patients with worsened disease
[Time Frame: one year]
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Adverse events
[Time Frame: one year]
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Secondary ID(s)
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GMMA-Fecal Tx-1
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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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