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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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19 February 2015 |
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Main ID: |
NCT01201434 |
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Date of registration:
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31/08/2010 |
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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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Effect of Probiotics on Sputum Inflammation and Pulmonary Infections in Patients With Cystic Fibrosis
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Scientific title:
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The Effect of Probiotics on Sputum Bacteria, Sputum Inflammation, and Pulmonary Infections in Patients With Cystic Fibrosis: A Double-blind Placebo-controlled Trial |
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Date of first enrolment:
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October 2010 |
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Target sample size:
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12 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT01201434 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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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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Batia Weiss, 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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Pediatric Gastroenterology Unit, Edmond and Lily Safra Children's Hospital, Sheba Medical Center |
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Name:
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Ori Efrati, 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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Pediatric Pulmonology Unit, Edmond and Lily safra Children's Hospital, Sheba Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- cystic fibrosis mild to moderate
- at least 3 pulmonary exacerbations requiring antibiotics per year
- Pseudomonas aeruginosa in the sputum
- able to produce sputum
Exclusion Criteria:
- severe pulmonary disease
- less than 3 pulmonary exacerbations per year
- unable to produce sputum
Age minimum:
5 Years
Age maximum:
40 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Dietary Supplement: Bio-25 probiotic
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Primary Outcome(s)
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The effect of probiotics on the rate of pulmonary infections compared to placebo
[Time Frame: October 2012]
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Secondary Outcome(s)
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The effect of probiotics on sputum inflammatory markers
[Time Frame: October 2012]
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The effect of probiotics on gastrointestinal inflammation
[Time Frame: October 2012]
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The effect of probiotics on sputum bacteria compared to placebo
[Time Frame: October 2012]
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Secondary ID(s)
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SHEBA-10-7702-BW-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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