Effect of Probiotics on Sputum Inflammation and Pulmonary Infections in Patients With Cystic Fibrosis

NCT01201434 | Terminated

• 1 other identifier: SHEBA-10-7702-BW-CTIL
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients with Cystic Fibrosis have multiple pulmonary infections and repeated antibiotic treatment. These factors taken together with high sputum viscosity and slow motility of the gastrointestinal tract-may change the pathogenicity and consistency of the intestinal pathogens. Part of the pulmonary infections in CF patients are due to intestinal pathogens. A pilot study performed by the researchers using probiotics in CF patients showed a decrease in the rate of pulmonary infections. Therefore,we planned a double-blind placebo-controlled trial to examine the effect of probiotics on pulmonary infections, sputum bacteria and sputum inflammatory markers in CF patients.

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis; probiotics; pulmonary; infections

Outcome Measures

Primary Outcomes (1)

• The effect of probiotics on the rate of pulmonary infections compared to placebo

  The rate of pulmonary exacerbations requiring IV or PO antibiotic treatment during the study period in the treatment and placebo groups will be assessed.

  October 2012

Secondary Outcomes (3)

• The effect of probiotics on sputum bacteria compared to placebo

  October 2012

• The effect of probiotics on sputum inflammatory markers

  October 2012

• The effect of probiotics on gastrointestinal inflammation

  October 2012

Study Arms (1)

Probiotics, Treatment, Food Additive

EXPERIMENTAL

Dietary Supplement: Bio-25 probiotic

Interventions

Bio-25 probiotic DIETARY_SUPPLEMENT

2 tablets per day for 6 months

Also known as: Bio-25 by Supherb

Probiotics, Treatment, Food Additive

Eligibility Criteria

• Age: 5 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• cystic fibrosis mild to moderate
• at least 3 pulmonary exacerbations requiring antibiotics per year
• Pseudomonas aeruginosa in the sputum
• able to produce sputum

You may not qualify if:

• severe pulmonary disease
• less than 3 pulmonary exacerbations per year
• unable to produce sputum

Sponsors & Collaborators

• Sheba Medical Center: lead

Related Publications (1)

• Weiss B, Bujanover Y, Yahav Y, Vilozni D, Fireman E, Efrati O. Probiotic supplementation affects pulmonary exacerbations in patients with cystic fibrosis: a pilot study. Pediatr Pulmonol. 2010 Jun;45(6):536-40. doi: 10.1002/ppul.21138.

  PMID: 20503277 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis; Infections

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 Officials

• Batia Weiss, MD

  Pediatric Gastroenterology Unit, Edmond and Lily Safra Children's Hospital, Sheba Medical Center

  PRINCIPAL INVESTIGATOR

• Ori Efrati, MD

  Pediatric Pulmonology Unit, Edmond and Lily safra Children's Hospital, Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pediatric Gastroenterology Unit, Edmond and Lily Safra Children's Hospital

Study Record Dates

• First Submitted: August 31, 2010
• First Posted: September 14, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 22, 2014

Record last verified: 2014-07