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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: |
NCT01961661 |
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Date of registration:
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09/10/2013 |
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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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Probiotics on Intestinal Inflammation in Cystic Fibrosis
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Scientific title:
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Effect of Probiotics on Intestinal Inflammation and Microflora in Cystic Fibrosis: a Pilot Study |
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Date of first enrolment:
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September 2009 |
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Target sample size:
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22 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01961661 |
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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), Primary Purpose: Prevention
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Phase:
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Phase 3
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Countries of recruitment
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Italy
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of CF documented by sweat chloride test over 60 mmol/L and confirmed by
genotype analysis with the presence of F508del/F508del or F508del/other;
- Boys and girls between 2 and 16 years of age;
- Clinical stability at enrolment, defined as no clinical evidence of acute
exacerbation, no modifications in the therapeutic regimen and no hospitalization in
the last 2 weeks;
- Pancreatic insufficiency;
- Basal Forced expiratory volume 1 second (FEV1) above 50% of predicted value.
Exclusion Criteria
- Colonization of respiratory tract with Burkholderia cepacia spp.;
- Steroid therapy within one month before enrolment;
- Pregnancy and fertile women taking oral contraceptives;
- Parenteral or oral antibiotics therapy within 2 weeks before enrolment;
- Regular assumption of probiotics;
- Regular assumption of azythromycin.
Age minimum:
2 Years
Age maximum:
18 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: placebo
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Dietary Supplement: Lactobacillus rhamnosus GG
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Primary Outcome(s)
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change in intestinal microflora composition
[Time Frame: baseline and 1 month after treatment]
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Modification of intestinal inflammation
[Time Frame: baseline and after 1 month of treatment]
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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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