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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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16 December 2017 |
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Main ID: |
NCT02909244 |
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Date of registration:
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05/09/2016 |
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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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Study of Gut Microbiota in Primary Immune Deficiency, Possibly Associated With Inflammatory Bowel Disease
DIPobiota |
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Scientific title:
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Study of Gut Microbiota in Primary Immune Deficiencies, Possibly Associated With Inflammatory Bowel Disease (Chronic Granulomatous Disease, XIAP Gene Deficiency, or TTC7A Gene Deficiency) |
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Date of first enrolment:
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February 2015 |
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Target sample size:
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51 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02909244 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Sylvain Latour |
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Address:
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Telephone:
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Email:
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Affiliation:
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Imagine Institute |
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Name:
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Alain Fischer |
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Address:
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Telephone:
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Email:
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Affiliation:
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Imagine Institute |
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Name:
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Harry Sokol |
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Address:
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Telephone:
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Email:
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Affiliation:
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Saint-Antoine Hospital |
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Name:
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Olivier Join-Lambert |
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Address:
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Telephone:
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Email:
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Affiliation:
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Necker - Enfants malades Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria (Patients with one of the 3 specific PID mentioned above):
- Presenting a Primary Immune Deficiency (CGD, XIAP ou TTC7A deficiency) with or without
inflammatory digestive disease
Inclusion Criteria (Control patients without one of the 3 specific PID mentioned above):
- No antibiotic treatment in the month preceding the inclusion
Exclusion Criteria (all patients):
- Patients having a received a gene therapy or a Hematopoietic stem cell transplantation
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Primary Immune Deficiencies
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Intervention(s)
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Biological: Biological sampling
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Primary Outcome(s)
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Number of factors associated with the onset of an inflammatory colitis in patients with three Primary Immuno-Deficiencies, identified in the study population
[Time Frame: 3 years and 8 months]
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Secondary ID(s)
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IMIS2014-02
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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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