Probiotics on Intestinal Inflammation in Cystic Fibrosis

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Probiotics on Intestinal Inflammation and Microflora in Cystic Fibrosis: a Pilot Study

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Dietary Supplement: Lactobacillus rhamnosus GG
* Dietary Supplement: placebo


Participation Criteria
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Eligibility 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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: probiotic<br>Lactobacillus rhamnosus GG 5x10^9 colony forming units (CFU)per day | Dietary Supplement: Lactobacillus rhamnosus GG<br>* 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<br>* Other names: LGG;|
| Placebo Comparator: placebo<br>maltodextrins | Dietary Supplement: placebo<br>* Capsules containing maltodextrin (163 mg), gelatine capsule (75 mg), magnesium stearate (2 mg) 1 cps/die for 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modification of intestinal inflammation | Evaluation of intestinal inflammation at baseline and 1 month after treatment | baseline and after 1 month of treatment | 
| change in intestinal microflora composition | Modification of Fluorescent in Situ Hybridization profile of intestinal microflora at baseline and 1 month of treatment | baseline and 1 month after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intestinal inflammation, intestinal microflora, children