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OpenTrials
Completed

NCT Number: NCT01961661

Probiotics on Intestinal Inflammation in Cystic Fibrosis

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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Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Pediatrics University Federico II

Naples, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactobacillus rhamnosus GG

Dietary Supplement

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

Placebo

Dietary Supplement

Capsules containing maltodextrin (163 mg), gelatine capsule (75 mg), magnesium stearate (2 mg)

1 cps/die for 12 months

Primary outcomes

  1. Modification of intestinal inflammation

    Time frame: baseline and after 1 month of treatment

    Evaluation of intestinal inflammation at baseline and 1 month after treatment

  2. change in intestinal microflora composition

    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

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
First posted
Oct 11, 2013
Registry last updated
Oct 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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