Effect of Lactobacillus Reuteri in Cystic Fibrosis

NCT ID: NCT01737983

Last Updated: 2012-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-07-31

Brief Summary

The purpose of this study is to evaluate in patients with cystic fibrosis the effect of Lactobacillus Reuteri (LR) on the rate of respiratory exacerbations and of the infections of both upper respiratory and gastrointestinal tracts.

Detailed Description

The hallmarks of cystic fibrosis (CF) are recurrent severe and destructive pulmonary inflammation and infection, beginning in early childhood and leading to morbidity and mortality due to respiratory failure. During the disease, most children become colonized with Pseudomonas aeruginosa (PA) and undergo progressive impairment of respiratory function. Therefore, patients colonized with Pseudomonas are at increased risk for pulmonary infections and persistent inflammation and have a decrease in survival rate. In an attempt to reduce the rate and severity of pulmonary exacerbations, children with CF are put on heavy load of antibiotics.

Intestinal inflammation is another typical finding in CF patients and gut bacterial overgrowth may be present.

Probiotics are live bacteria administered orally, successfully used in children with acute gastroenteritis, as well as in preventing and treating atopic diseases in children. In addition, probiotics have been used as adjuvant therapy in patients with pouchitis and inflammatory bowel diseases. Interestingly, probiotic supplementation is able to reduce the incidence of fever, child care absences, antibiotic prescription and to prevent nosocomial gastrointestinal and respiratory infections. The effect of probiotics may be through improvement of intestinal barrier function and modulation of immune response. The latter mechanism could well explain the clinical effects of probiotics observed in extraintestinal diseases.

Conditions

CYSTIC FIBROSIS

Keywords

cystic fibrosis; probiotics; Lactobacillus reuteri

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lactobacillus reuteri (LR) ATCC55730

The tested probiotic, Lactobacillus reuteri, was administered in 5 drops per day (10\^10 colony-forming units) for 6 months

Group Type: EXPERIMENTAL

Lactobacillus reuteri

Intervention Type: DIETARY_SUPPLEMENT

Lactobacillus reuteri was administered in 5 drops per day (10\^10 colony-forming units) for 6 months.

placebo

The placebo was packed in identical bottles, had the same color, weight, smell, and taste of the probiotic formulation for 6 months During the test period, patients were not allowed to consume any other product that contained probiotics or prebiotics

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

The placebo was packed in identical bottles, had the same color, weight, smell, and taste of the probiotic formulation, was administered in 5 drops per day

Interventions

Lactobacillus reuteri

Lactobacillus reuteri was administered in 5 drops per day (10\^10 colony-forming units) for 6 months.

Intervention Type: DIETARY_SUPPLEMENT

placebo

The placebo was packed in identical bottles, had the same color, weight, smell, and taste of the probiotic formulation, was administered in 5 drops per day

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

(LR) ATCC55730

Eligibility Criteria

Inclusion Criteria

• Forced expiratory volume in the 1st second (FEV1) > 70%.
• No inhaled or systemic steroids.
• No anti-inflammatory drugs, antileukotrienes and mast cell membrane stabilizers.
• No serious organ involvement.

Exclusion Criteria

• History of pulmonary exacerbation or upper respiratory infection in the previous two months.
• Changes in medications in the past two months.
• History of hemoptysis in the past two months.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Policlinico Umberto I

OTHER

Sponsor Role: lead

Responsible Party

Giovanni Di Nardo

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dipartimento di pediatria e neuropsichiatria Policlinico Umberto l "Università di Roma la Sapienza"

Roma, , Italy

Countries

Italy

References

Di Nardo G, Oliva S, Menichella A, Pistelli R, De Biase RV, Patriarchi F, Cucchiara S, Stronati L. Lactobacillus reuteri ATCC55730 in cystic fibrosis. J Pediatr Gastroenterol Nutr. 2014 Jan;58(1):81-6. doi: 10.1097/MPG.0000000000000187.

Reference Type: DERIVED

PMID: 24121143 (View on PubMed)

Other Identifiers

lactobacillus reuteri in fc

Identifier Type: -

Identifier Source: org_study_id