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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date October 2020
Source State University of New York at Buffalo
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Microbiome


Locations

Country Name City State
United States State University of New York at Buffalo, Farber Hall Buffalo New York

Sponsors (1)

Lead Sponsor Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

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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