Gut Microbiome Clinical Trial
Official title:
The Neonatal Microbiome Study: Validity of Biologic Sample Collection Methods
NCT number | NCT02655250 |
Other study ID # | 758632-1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2015 |
Est. completion date | December 2017 |
Verified date | October 2020 |
Source | State University of New York at Buffalo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 5 |
Est. completion date | December 2017 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Lactating women (for breast milk sample) Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
United States | State University of New York at Buffalo, Farber Hall | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
State University of New York at Buffalo |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in intestinal microbiome between gold standard and proposed field protocol | 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. | Baseline | |
Primary | Difference in breast milk microbiome between gold standard and proposed field protocol | Comparison of microbiome from snap-frozen sample to proposed field collection methods to determine which field method best correlates with the snap-frozen sample. | Baseline |
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