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

NCT00977158 — Withdrawn, Tufts Medical Center

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Registry	NCT00977158
Status	Withdrawn - No problems with planned study- insufficient funding for this study to proceed.
Study type	Observational
Sponsor	Tufts Medical Center (Other)
Conditions	Cystic Fibrosis
Interventions	Throat Swab (Procedure)
Dates	start 2011-05-01, first posted 2009-09-15, last updated 2015-03-18
Locations	2 sites in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Throat Swab		Procedure: Throat Swab	Infants who have been diagnosed with cystic fibrosis

Throat Swab (Procedure): 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 outcomes

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 [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 [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 [6-8 weeks of age, 3 months, 6 months, 9 months, and 12 months of age]

+Eligibility

Sex: All, ages: 1 Day to 3 Months

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

+Locations (2)

Facility	City	Country	Status
Floating Hospital for Children at Tufts Medical Center	Boston, Massachusetts	United States
Children's Hospital Boston	Boston, Massachusetts	United States

+Investigators

Patricia L Hibberd, MD, PhD, Principal investigator, Tufts Medical Center