Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-02-21 @ 10:11 PM
Study NCT ID:
NCT02655250
Status:
COMPLETED
Last Update Posted:
2020-10-27
First Post:
2015-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neonatal Microbiome Validity Study
Sponsor:
State University of New York at Buffalo
Organization:
Study Overview
Official Title:
The Neonatal Microbiome Study: Validity of Biologic Sample Collection Methods
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: