Cystic fibrosis
Conditions
Interventions
Cystic fibrosis Experimental group: 25 patients will undergo daily supplementation with 6 grams of synbiotic (fructooligosaccharides, Lactobacillus paracasei, Lactobacillus rhamnosus, Lactobacillus ac
Dietary supplement
SP6.051.227
Sponsors
Universidade Federal de Santa Catarina
Universidade Federal de Santa Catarina
Eligibility
Age
0 Years to 15 Years
Inclusion criteria
Inclusion criteria: Cystic fibrosis group: Children and adolescents up to and including age zero and less than or equal to 15 years; to present a diagnosis of HR based on the sweat test (sweat chloride 60 mmol / L); clinically at least 30 days prior to data collection. For controls without cystic fibrosis: children and adolescents aged 0 years and 15 years without cystic fibrosis; clinically stable at least 30 days prior to data collection
Exclusion criteria
Exclusion criteria: Subjects with fever, trauma, inflammatory diseases (asthma, inflammatory bowel disease, rheumatic disease), psychiatric, degenerative, cardiovascular, diabetes, glucose intolerance, renal failure, primary or secondary immunodeficiency Subjects undergoing antibiotic use at baseline, hormones, non-hormonal anti-inflammatory drugs, immunosuppressants and antihistamines, up to 30 days prior to data collection and subjects in pulmonary exacerbation
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| A decrease or at least a stabilization of nutritional status is expected, reflected by pulmonary function data, anthropometric biochemistry, body composition and the functional marker of nutritional status. The markers to be evaluated are: Shwachman-Kulczycki score (S-K score); Pulmonary function (forced expiratory volume in the first second, forced vital capacity); Biochemical Indicators (Total Leukocytes, Neutrophils, Lymphocytes, Monocytes); Anthropometric indicators (BMI / Age, Weight / age, Height / Age); Indicators body composition (fat area of the arm, arm muscle area,% body fat); Functional indicator of nutritional status (Handshaking force). A variation of at least 5% in pre- and post-intervention measurements will be required to verify the difference. | — |
Primary
| Measure | Time frame |
|---|---|
| An improvement in inflammatory markers is expected in the symbiotic supplemented group compared to placebo. Inflammatory markers dosed by flow cytometry are: IL-1beta, IL-8, IL-10, IL-17A, TGF-beta, TNF-alpha, INF-gamma. A variation of at least 5% in pre- and post-intervention measurements will be required to verify the difference. ;Intestinal inflammation will be assessed by fecal calprotectin and a variation of at least 5% in pre and post-intervention measurements will be required to verify the difference.;Analysis of the intestinal microbiota will be performed by fluorescence in situ hybridization (FISH) and the variation of at least 5% in the pre- and post-intervention measurements will be required to verify the difference. | — |
Countries
Brazil
Contacts
Public ContactEmilia Machado Moreira
Universidade Federal de Santa Catarina
Outcome results
None listed