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

Primary Purpose

Cystic Fibrosis

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bio-25 probiotic
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cystic Fibrosis focused on measuring cystic fibrosis, probiotics, pulmonary, infections

Eligibility Criteria

5 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Probiotics, Treatment, Food Additive

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    The effect of probiotics on sputum bacteria compared to placebo
    The effect of probiotics on sputum inflammatory markers
    The effect of probiotics on gastrointestinal inflammation

    Full Information

    First Posted
    August 31, 2010
    Last Updated
    July 21, 2014
    Sponsor
    Sheba Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01201434
    Brief Title
    Effect of Probiotics on Sputum Inflammation and Pulmonary Infections in Patients With Cystic Fibrosis
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Terminated
    Why Stopped
    Severe allergic reaction in one patient
    Study Start Date
    October 2010 (undefined)
    Primary Completion Date
    December 2013 (Actual)
    Study Completion Date
    December 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sheba Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cystic Fibrosis
    Keywords
    cystic fibrosis, probiotics, pulmonary, infections

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Probiotics, Treatment, Food Additive
    Arm Type
    Experimental
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Bio-25 probiotic
    Other Intervention Name(s)
    Bio-25 by Supherb
    Intervention Description
    2 tablets per day for 6 months
    Primary Outcome Measure Information:
    Title
    The effect of probiotics on the rate of pulmonary infections compared to placebo
    Description
    The rate of pulmonary exacerbations requiring IV or PO antibiotic treatment during the study period in the treatment and placebo groups will be assessed.
    Time Frame
    October 2012
    Secondary Outcome Measure Information:
    Title
    The effect of probiotics on sputum bacteria compared to placebo
    Time Frame
    October 2012
    Title
    The effect of probiotics on sputum inflammatory markers
    Time Frame
    October 2012
    Title
    The effect of probiotics on gastrointestinal inflammation
    Time Frame
    October 2012

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Batia Weiss, MD
    Organizational Affiliation
    Pediatric Gastroenterology Unit, Edmond and Lily Safra Children's Hospital, Sheba Medical Center
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ori Efrati, MD
    Organizational Affiliation
    Pediatric Pulmonology Unit, Edmond and Lily safra Children's Hospital, Sheba Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20503277
    Citation
    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.
    Results Reference
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    Effect of Probiotics on Sputum Inflammation and Pulmonary Infections in Patients With Cystic Fibrosis

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