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

This study has been withdrawn prior to enrollment.
(No problems with planned study- insufficient funding for this study to proceed.)
Sponsor:
Information provided by:
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT00977158
First received: September 14, 2009
Last updated: May 16, 2011
Last verified: May 2011
  Purpose

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 Intervention
Cystic Fibrosis
Procedure: Throat Swab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Microbiota of the Respiratory Flora in Children With Cystic Fibrosis During the First Year of Life

Resource links provided by NLM:


Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: May 2011
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
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
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: NCT00977158

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

No publications provided

Responsible Party: Patricia L. Hibberd, MD, PhD, Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00977158     History of Changes
Other Study ID Numbers: 8851
Study First Received: September 14, 2009
Last Updated: May 16, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 16, 2014