Department of Pediatrics University Federico II
Naples, Italy
NCT Number: NCT01961661
Cystic fibrosis (CF) is a complex systemic disease that mainly involves the respiratory and gastrointestinal (GI) tracts. The polymicrobial community composition of respiratory and GI tracts is influenced by both genetic and environmental factors. Children with CF may harbor an abnormal intestinal microflora, because of altered Cystic fibrosis transmembrane conductance regulator (CFTR) function and heavy drug load (antibiotics, pancreatic enzymes and acid suppressors). The investigators previously demonstrated that intestinal inflammation is highly frequent in CF children, being a major feature of intestinal involvement. In addition, specific probiotics significantly improved airway and GI inflammation in a preliminary trial. The aim of the study is to characterize intestinal and respiratory microflora in CF patients and to investigate the effects of daily Lactobacillus GG (LGG) supplementation on both GI and airway microflora and the eventual relationship between probiotic assumption and clinical and inflammation markers. The aim is to study the effect of microflora modification on intestinal and extraintestinal inflammation to eventually improve the quality of life of CF patients, who often suffer from intestinal and respiratory progressive disease, through a non invasive intervention consisting in the supplementation of probiotic bacteria.
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Notify Me2 year–18 year
All sexes
Interventional
Phase 3
Naples, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Capsules containing lyophilized 6x10^9 Colony Forming Units (CFU)/die LGG, (60mg) maltodextrin (163 mg), gelatine capsule (75 mg), magnesium stearate (2 mg)
1 capsule/die for 1 month
Other names: LGG
Capsules containing maltodextrin (163 mg), gelatine capsule (75 mg), magnesium stearate (2 mg)
1 cps/die for 12 months
Time frame: baseline and after 1 month of treatment
Evaluation of intestinal inflammation at baseline and 1 month after treatment
Time frame: baseline and 1 month after treatment
Modification of Fluorescent in Situ Hybridization profile of intestinal microflora at baseline and 1 month of treatment
Federico II University
Other
Effect of Probiotics on Intestinal Inflammation and Microflora in Cystic Fibrosis: a Pilot Study
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