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Completed

NCT Number: NCT01737983

Effect of Lactobacillus Reuteri in Cystic Fibrosis

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.

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Key information

Age range

6 year–42 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Roma, 00161, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactobacillus reuteri

Dietary Supplement

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

Other names: (LR) ATCC55730

Placebo

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

Primary outcomes

  1. Efficacy

    Time frame: 6 months of observation

    Evaluate number of episodes of pulmonary exacerbations that were diagnosed by increase in pulmonary symptoms and airway secretions requiring oral or intravenous antibiotics.

  2. Efficacy

    Time frame: 6 months of observation

    Evaluate number of hospital admissions required for pulmonary exacerbations in the two groups.

  3. efficacy

    Time frame: 6 months of observation

    Evaluate number of gastrointestinal and upper respiratory tract infections.

  4. efficacy

    Time frame: 6 months of observation

    Evaluate duration of hospital admissions required for pulmonary exacerbations in the two groups.

Secondary outcomes

  1. efficacy

    Time frame: 6 months of observation

    Evaluate change in qualitative sputum bacteria;

  2. efficacy

    Time frame: 6 months of observation

    Evaluate change in fecal calprotectin concentration.

  3. efficacy

    Time frame: 6 months of observation

    Evaluate interleukin 8 levels in plasma and induced sputum.

  4. efficacy

    Time frame: 6 months of observation

    Evaluate change in quantitative sputum bacteria;

  5. efficacy

    Time frame: 6 months of observation

    Evaluate tumor necrosis factor α levels in plasma and induced sputum.

Sponsors and collaborators

Lead sponsor

Azienda Policlinico Umberto I

Other

Registry information

Official study title

Lactobacillus Reuteri Reduces Pulmonary Exacerbations and Upper Respiratory Tract Infections in CF Patients With Mild-to-moderate Lung Disease. LR Administration Might Have a Beneficial Effect on the Disease Course of Cystic Fibrosis.

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 30, 2012
Registry last updated
Nov 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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