Probiotics on Intestinal Inflammation in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01961661
• Other study ID #: CF pilot
• Status: Completed
• Phase: Phase 3
• First received: October 9, 2013
• Last updated: October 11, 2013
• Start date: September 2009

Study information

• Verified date: October 2013
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency- AIFA
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Inflammation

Intervention

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

Locations

Country	Name	City	State
Italy	Department of Pediatrics University Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. Epub 2007 Mar 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modification of intestinal inflammation	Evaluation of intestinal inflammation at baseline and 1 month after treatment	baseline and after 1 month of treatment	No
Primary	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	No