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

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ClinicalTrials.gov Identifier: NCT00977158
Recruitment Status : Withdrawn (No problems with planned study- insufficient funding for this study to proceed.)
First Posted : September 15, 2009
Last Update Posted : March 18, 2015
Sponsor:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Cystic Fibrosis Procedure: Throat Swab

Study Design

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Microbiota of the Respiratory Flora in Children With Cystic Fibrosis During the First Year of Life
Study Start Date : May 2011

Resource links provided by the National Library of Medicine

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

Groups and Cohorts

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.


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infants with cystic fibrosis
Criteria

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
Contacts and Locations

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): NCT00977158


Locations
United States, Massachusetts
Floating Hospital for Children at Tufts Medical Center
Boston, Massachusetts, United States, 02111
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Tufts Medical Center
Investigators
Principal Investigator: Patricia L Hibberd, MD, PhD Tufts Medical Center
More Information

Responsible Party: Patricia L. Hibberd, MD, PhD, Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00977158     History of Changes
Other Study ID Numbers: 8851
First Posted: September 15, 2009    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015

Keywords provided by Tufts Medical Center:
Cystic Fibrosis
Microbiota
upper respiratory tract
16S rRNA sequence analysis
Staphylococcus aureus
Pseudomonas aeruginosa
Burkholderia cepacia
Haemophilus influenzae
Streptococcus pneumoniae

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