Neonatal Microbiome Validity Study
- Conditions
- Gut Microbiome
- Registration Number
- NCT02655250
- Lead Sponsor
- State University of New York at Buffalo
- Brief Summary
This is a validation study to compare proposed field collection methods with a gold standard collection technique for microbiome analysis of stool and breast milk samples.
- Detailed Description
In order to conduct a future study of the gut microbiome in a population living in a rural, low income setting, this validation study will be conducted to verify the validity of our proposed field collection methods for stool and breast milk samples. We will compare the microbial diversity and abundance in the biologic samples using various proposed field collection methods to an immediately frozen sample. The proposed field collection methods are feasible for use in a community-based study in a low income setting with limited access to cold storage.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
- Lactating women (for breast milk sample)
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in intestinal microbiome between gold standard and proposed field protocol Baseline Comparison of microbiome from snap-frozen sample (gold standard) to proposed field collection methods to determine which field method best correlates with the snap-frozen sample.
Difference in breast milk microbiome between gold standard and proposed field protocol Baseline Comparison of microbiome from snap-frozen sample to proposed field collection methods to determine which field method best correlates with the snap-frozen sample.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
State University of New York at Buffalo, Farber Hall
🇺🇸Buffalo, New York, United States
State University of New York at Buffalo, Farber Hall🇺🇸Buffalo, New York, United States