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No problems with planned study- insufficient funding for this study to proceed.
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Throat Swab | Infants who have been diagnosed with cystic fibrosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Infants with cystic fibrosis
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| Name | Affiliation | Role |
|---|---|---|
| Patricia L Hibberd, MD, PhD | Tufts Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Floating Hospital for Children at Tufts Medical Center | Boston | Massachusetts | 02111 | United States | ||
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D013203 | Staphylococcal Infections |
| D011552 | Pseudomonas Infections |
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Children's Hospital Boston |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D016871 | Pasteurellaceae Infections |