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Trial record 22 of 98 for:    Lactobacillus | maltodextrin

Probiotics on Intestinal Inflammation in Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT01961661
Recruitment Status : Completed
First Posted : October 11, 2013
Last Update Posted : October 14, 2013
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 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.

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 : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Probiotics on Intestinal Inflammation and Microflora in Cystic Fibrosis: a Pilot Study
Study Start Date : September 2009
Actual Primary Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: probiotic
Lactobacillus rhamnosus GG 5x10^9 colony forming units (CFU)per day
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 capsule/die for 1 month

Other Name: LGG

Placebo Comparator: placebo
maltodextrins
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. 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



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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:

  • 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.

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): NCT01961661


Locations
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Italy
Department of Pediatrics University Federico II
Naples, 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: NCT01961661     History of Changes
Other Study ID Numbers: CF pilot
First Posted: October 11, 2013    Key Record Dates
Last Update Posted: October 14, 2013
Last Verified: October 2013
Keywords provided by Alfredo Guarino, Federico II University:
intestinal inflammation
intestinal microflora
children
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Inflammation
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases