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Probiotics on Intestinal Inflammation in Cystic Fibrosis

NCT ID: NCT01961661

Last Updated: 2013-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cystic Fibrosis

Keywords

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intestinal inflammation intestinal microflora children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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probiotic

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

Group Type EXPERIMENTAL

Lactobacillus rhamnosus GG

Intervention Type 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

placebo

maltodextrins

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

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

1 cps/die for 12 months

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

placebo

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

1 cps/die for 12 months

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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LGG

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Alfredo Guarino

Full professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Pediatrics University Federico II

Naples, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 17360077 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15379842 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24586292 (View on PubMed)

Other Identifiers

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CF pilot

Identifier Type: -

Identifier Source: org_study_id