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

This study has been terminated.
(Severe allergic reaction in one patient)
Sponsor:
Information provided by (Responsible Party):
Batia Weiss, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01201434
First received: August 31, 2010
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Cystic Fibrosis
Dietary Supplement: Bio-25 probiotic

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Probiotics on Sputum Bacteria, Sputum Inflammation, and Pulmonary Infections in Patients With Cystic Fibrosis: A Double-blind Placebo-controlled Trial

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • The effect of probiotics on the rate of pulmonary infections compared to placebo [ Time Frame: October 2012 ] [ Designated as safety issue: No ]
    The rate of pulmonary exacerbations requiring IV or PO antibiotic treatment during the study period in the treatment and placebo groups will be assessed.


Secondary Outcome Measures:
  • The effect of probiotics on sputum bacteria compared to placebo [ Time Frame: October 2012 ] [ Designated as safety issue: No ]
  • The effect of probiotics on sputum inflammatory markers [ Time Frame: October 2012 ] [ Designated as safety issue: No ]
  • The effect of probiotics on gastrointestinal inflammation [ Time Frame: October 2012 ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: October 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotics, Treatment, Food Additive Dietary Supplement: Bio-25 probiotic
2 tablets per day for 6 months
Other Name: Bio-25 by Supherb

Detailed Description:

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. The study will be a cross-over study of probiotic and placebo arms.

  Eligibility

Ages Eligible for Study:   5 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • severe pulmonary disease
  • less than 3 pulmonary exacerbations per year
  • unable to produce sputum
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01201434

Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: 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
  More Information

Publications:
Responsible Party: Batia Weiss, Director, Pediatric Gastroenterology Unit, Edmond and Lily Safra Children's Hospital, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01201434     History of Changes
Other Study ID Numbers: SHEBA-10-7702-BW-CTIL
Study First Received: August 31, 2010
Last Updated: July 21, 2014
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
cystic fibrosis
probiotics
pulmonary
infections

Additional relevant MeSH terms:
Infection
Inflammation
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on October 01, 2014