ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01201434
Recruitment Status : Terminated (Severe allergic reaction in one patient)
First Posted : September 14, 2010
Last Update Posted : July 22, 2014
Sponsor:
Information provided by (Responsible Party):
Batia Weiss, Sheba Medical Center

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Dietary Supplement: Bio-25 probiotic Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : October 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Probiotics, Treatment, Food Additive Dietary Supplement: Bio-25 probiotic
2 tablets per day for 6 months
Other Name: Bio-25 by Supherb



Primary Outcome Measures :
  1. The effect of probiotics on the rate of pulmonary infections compared to placebo [ Time Frame: October 2012 ]
    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 :
  1. The effect of probiotics on sputum bacteria compared to placebo [ Time Frame: October 2012 ]
  2. The effect of probiotics on sputum inflammatory markers [ Time Frame: October 2012 ]
  3. The effect of probiotics on gastrointestinal inflammation [ Time Frame: October 2012 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   5 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 14, 2010    Key Record Dates
Last Update Posted: July 22, 2014
Last Verified: July 2014

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

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