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Trial record 23 of 97 for:    Lactobacillus | maltodextrin

Probiotics in Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT01956916
Recruitment Status : Completed
First Posted : October 8, 2013
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):
Alfredo Guarino, Federico II University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Dietary Supplement: Lactobacillus rhamnosus GG Dietary Supplement: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effects of LGG Administration in Children With Cystic Fibrosis: A Randomized Controlled Trial
Study Start Date : October 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: Probiotics
Capsules containing lyophilized 6x10^9 Colony Forming Units (CFU)/die of Lactobacillus rhamnosus GG (LGG)
Dietary Supplement: Lactobacillus rhamnosus GG

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 Name: LGG

Placebo Comparator: Placebo
Capsules containing maltodextrin
Dietary Supplement: placebo

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

1 cps/die for 12 months





Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Boys and girls between 2 and 16 years of age
  3. 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
  4. Pancreatic insufficiency
  5. Basal Forced Expiratory Volume 1 second above 50% of predicted value

Exclusion Criteria:

  1. Colonization of respiratory tract with Burkholderia cepacia spp.
  2. Steroid therapy within one month before enrolment
  3. Pregnancy and fertile women taking oral contraceptives
  4. Parenteral or oral antibiotics therapy within 2 weeks before enrolment
  5. Regular assumption of probiotics
  6. Regular assumption of azythromycin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956916


Locations
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Italy
- Department of Paediatric Medicine, CF Center, "A. Meyer" Children's Hospital
Florence, Italy
Dipartimento di Pediatria - Università Di Messina
Messina, Italy
Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
Milano, Italy
Università degli studi di Napoli "Federico II"
Napoli, Italy
Ospedale "Bambino Gesù" - Roma
Rome, Italy
Sponsors and Collaborators
Federico II University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alfredo Guarino, Full Professor Of Pediatrics, Federico II University
ClinicalTrials.gov Identifier: NCT01956916     History of Changes
Other Study ID Numbers: CF001
2009-011289-27 ( EudraCT Number )
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015
Keywords provided by Alfredo Guarino, Federico II University:
Pulmonary exacerbation
Inflammation
Intestinal microbiota
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases