Probiotics on Intestinal Inflammation in Cystic Fibrosis

NCT01961661 | Completed Phase 3

• 1 other identifier: CF pilot
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

intestinal inflammation; intestinal microflora; children

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

probiotic

EXPERIMENTAL

Lactobacillus rhamnosus GG 5x10\^9 colony forming units (CFU)per day

Dietary Supplement: Lactobacillus rhamnosus GG

placebo

PLACEBO COMPARATOR

maltodextrins

Dietary Supplement: placebo

Interventions

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

Also known as: LGG

probiotic

placebo DIETARY_SUPPLEMENT

Capsules containing maltodextrin (163 mg), gelatine capsule (75 mg), magnesium stearate (2 mg) 1 cps/die for 12 months

placebo

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Department of Pediatrics University Federico II

Naples, Italy

Location

Related Publications (3)

• Bruzzese E, Raia V, Spagnuolo MI, Volpicelli M, De Marco G, Maiuri L, Guarino A. Effect of Lactobacillus GG supplementation on pulmonary exacerbations in patients with cystic fibrosis: a pilot study. Clin Nutr. 2007 Jun;26(3):322-8. doi: 10.1016/j.clnu.2007.01.004. Epub 2007 Mar 13.

  PMID: 17360077 BACKGROUND

• Bruzzese E, Raia V, Gaudiello G, Polito G, Buccigrossi V, Formicola V, Guarino A. Intestinal inflammation is a frequent feature of cystic fibrosis and is reduced by probiotic administration. Aliment Pharmacol Ther. 2004 Oct 1;20(7):813-9. doi: 10.1111/j.1365-2036.2004.02174.x.

  PMID: 15379842 BACKGROUND

• Bruzzese E, Callegari ML, Raia V, Viscovo S, Scotto R, Ferrari S, Morelli L, Buccigrossi V, Lo Vecchio A, Ruberto E, Guarino A. Disrupted intestinal microbiota and intestinal inflammation in children with cystic fibrosis and its restoration with Lactobacillus GG: a randomised clinical trial. PLoS One. 2014 Feb 19;9(2):e87796. doi: 10.1371/journal.pone.0087796. eCollection 2014.

  PMID: 24586292 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor of Pediatrics

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: October 11, 2013
• Study Start: September 1, 2009
• Primary Completion: December 1, 2009
• Last Updated: October 14, 2013

Record last verified: 2013-10

Locations

IT (1)