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Completed

NCT Number: NCT01956916

Probiotics 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 have 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 investigators aim 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 investigators aim is 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

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Inflammation Lung Diseases Pancreatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

- Department of Paediatric Medicine, CF Center, "A. Meyer" Children's Hospital, Florence, Italy

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A confirmed 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 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 cps/die for 12 months

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. Change in the incidence of pulmonary exacerbations from baseline to 12 months of treatment

    Time frame: every six months up to 18 months

    The incidence of pulmonary exacerbation is assessed every six months. First evaluation from baseline to 6 months of observation. Second evaluation from randomization ( placebo/LGG) to 6 months of treatment and third evaluation after 12 months of treatment

  2. Change of intestinal inflammation from baseline to 12 months of treatment

    Time frame: every six months up to 18 months

    Assessment of intestinal inflammation is performed four times. First time at enrollment, second time at the end of six months of observation. Third time after six months of treatment and fourth time after 12 months of treatment.

Secondary outcomes

  1. Change in the incidence of hospital admission from baseline to 12 months of treatment

    Time frame: every six month up to 18 months

    The incidence of hospital admission is assessed every six months. First evaluation from baseline to 6 months of observation. Second evaluation from randomization ( placebo/LGG) to 6 months of treatment and third evaluation after 12 months of treatment

  2. change in pulmonary function from baseline to 12 months of treatment (measured by Forced Expiratory Volume 1 sec (FEV1))

    Time frame: every six months up to 18 months

    Assessment of pulmonary function is performed four times. First time at enrollment, second time at the end of six months of observation. Third time after six months of treatment and fourth time after 12 months of treatment.

Other outcomes

  1. Change in the incidence of abdominal pain episodes from baseline to 12 months of treatment

    Time frame: every six months up to 18 months

    The incidence of abdominal pain episodes is assessed every six months. First evaluation from baseline to 6 months of observation. Second evaluation from randomization ( placebo/LGG) to 6 months of treatment and third evaluation after 12 months of treatment

  2. Change in systemic inflammation from baseline to 12 months of treatment

    Time frame: At baseline and after 12 months of treatment

    Assessment of intestinal microflora composition is performed 2 times. First time at randomization (placebo/LGG), second time at the end of 12 months of treatment.

  3. Change of intestinal microflora composition from baseline to 12 months of treatment

    Time frame: baseline and 12 months after treatment

    Assessment of intestinal microflora composition is performed 2 times. First time at randomization (placebo/LGG), second time at the end of 12 months of treatment.

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

Effects of LGG Administration in Children With Cystic Fibrosis: A Randomized Controlled Trial

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Oct 8, 2013
Registry last updated
Sep 23, 2015

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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