RBR‐5byrsc.

Trial name or title	Effect of supplementation with a synbiotic on markers of the inflammatory response in children and adolescents with cystic fibrosis.
Methods	Trial design: RCT. Trial grouping: parallel group. Randomisation method: not specified.
Participants	Inclusion criteria CF group Children and adolescents from age zero up to 15 years. Diagnosis of CF based on the sweat test (sweat chloride 60 mmol/L). Clinically stable at least 30 days prior to data collection. Controls without CF Children and adolescents from age zero up to 15 years. No CF. Clinically stable at least 30 days prior to data collection. Exclusion criteria With fever, trauma, inflammatory diseases (asthma, inflammatory bowel disease, rheumatic disease), psychiatric, degenerative, cardiovascular, diabetes, glucose intolerance, renal failure, primary or secondary immunodeficiency. Using antibiotics at baseline. Using hormones, non‐hormonal anti‐inflammatory drugs, immunosuppressants and antihistamines, up to 30 days prior to data collection. Experiencing a pulmonary exacerbation. Target sample size Probiotic group: n = 25. Placebo group: n = 25.
Interventions	Probiotic Preparation: 6 g synbiotic (fructo‐oligosaccharides, L paracasei, L rhamnosus, L acidophilus and B lactis) (dose and preparation not specified) Dose (probiotic): 6 g. Frequency of administration: daily. Duration: 90 days. Placebo Preparation: maltodextrin 6 g (preparation not specified). Dose (probiotic): 0. Frequency of administration: daily. Duration: 90 days.
Outcomes	Primary outcome measures Inflammatory markers measured by flow cytometry: IL‐1beta, IL‐8, IL‐10, IL‐17A, TGF‐beta, TNF‐alpha, INF‐gamma. Intestinal microbiota (FISH). Faecal calprotectin. Secondary outcome measures Pulmonary function data ‐ FEV1 % predicted, FVC. Anthropometric biochemistry (BMI/age, weight/age, height/age). Body composition (fat area of the arm, arm muscle area,% body fat). Functional indicator of nutritional status (handshaking force). Shwachman‐Kulczycki score. Biochemical Indicators (total leukocytes, neutrophils, lymphocytes, monocytes). Time points for measurements: baseline, 90 days. Length of follow‐up: 13 weeks.
Starting date	03 October 2014.
Contact information	Emilia Addison Machado Moreira Universidade Federal de Santa Catarina Campus Universitário, Trindade 88.040‐97 Florianópolis Brazil Phone: +55(48) 3721 9784 Email: emilia.moreira@ufsc.br
Notes

B: bifidobacterium
 BMI: body mass index
 CF: cystic fibrosis
 FEV₁: forced expiratory volume in 1 second
 FISH: fluorescence in situ hybridisation
 FVC: forced vital capacity
 HRQoL: health‐related quality of life
 IV: intravenous
 L: lactobacillus
 RCT: randomised controlled trial
 S: streptococcus