Microbiota of the Respiratory Flora in Children With Cystic Fibrosis During the First Year of Life

March 17, 2015 updated by: Tufts Medical Center
The goal of this study is characterize the changes in bacterial diversity of the upper respiratory tracts of infants with cystic fibrosis (CF). Another goal is to determine when CF patients become colonized with pathogenic bacteria that are responsible for the lethal lung damage in children with CF. Ten subjects will be recruited into the study. Throat swabs will be collected at 6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age in order to chart any changes in the bacterial populations of the respiratory tract. Clinical data will also be collected to evaluate the possible influence of external factors on changes in the microbial communities. This study will provide preliminary data on whether probiotics can eradicate the colonization of the respiratory tract by pathogenic bacteria.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital Boston
      • Boston, Massachusetts, United States, 02111
        • Floating Hospital for Children at Tufts Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 3 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Infants with cystic fibrosis

Description

Inclusion Criteria:

  • Male and female subjects, newborn to age 3 months
  • Have a diagnosis of cystic fibrosis (Diagnosis of CF will be based on either a positive sweat chloride of >60 mEq/L or the identification of two detectable mutations associated with CF
  • Parent/guardian plans to have follow-up care for approximately one year at designated CF clinic
  • Parent/guardian provides informed consent to participate in the study

Exclusion Criteria:

  • Contraindications for obtaining oropharyngeal swabs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Throat Swab
Infants who have been diagnosed with cystic fibrosis
Procedure: Throat Swab
Swabs will be moistened in sterile 0.9% sodium chloride solution and rotated in the throat and processed for bacterial cultures and for bacterial DNA extraction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To characterize the microbial ecology and changes in bacterial diversity of the oropharynx in a cohort of children with CF during the first year of life using 16S rRNA sequence analysis
Time Frame: 6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age
6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age
To describe the clinical variables that may be associated with changes in microbial ecology in children with cystic fibrosis over the first year of life
Time Frame: 6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age
6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age
To explore changes in the microbial ecology of the oropharynx in conjunction with Staphylococcus aureus colonization in children with CF
Time Frame: 6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age
6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Study Registration Dates

First Submitted

September 14, 2009

First Submitted That Met QC Criteria

September 14, 2009

First Posted (Estimate)

September 15, 2009

Study Record Updates

Last Update Posted (Estimate)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8851

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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