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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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17 October 2016 |
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Main ID: |
NCT02021084 |
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Date of registration:
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29/10/2013 |
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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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The Effect of Probiotics on Response to Therapy and on Adverse Effect in Patients Treated With Colchicine for Familial Mediterranean Fever.
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Scientific title:
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Date of first enrolment:
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December 2013 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02021084 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Contacts
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Name:
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Butbul Yonatan, M.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rambam medical center, Mayers childrens hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinical diagnosis of FMF
- Age 5-18 years
- Colchicine therapy
- Gastrointestinal adverse effect or recurrent FMF attacks on colchicine
Exclusion Criteria:
• Severe immune deficiency
Age minimum:
5 Years
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Familial Mediterranean Fever (FMF )
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Intervention(s)
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Dietary Supplement: probiotic
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Dietary Supplement: Placebo
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Primary Outcome(s)
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The number of gastrointestinal adverse effect related to colchicine therapy after adding probiotics to colchicine therapy.
[Time Frame: 6 months after enrollment assumed to be at 12/2014]
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Secondary Outcome(s)
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Number of FMF attacks after adding the probiotics to the colchicine therapy
[Time Frame: 6 months after enrollment assumed to be at 12/2014]
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Secondary ID(s)
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0173-13-RMB CTIL
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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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