Neonatal Microbiome Validity Study

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.

Completed

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Key information

Conditions

Gut Microbiome

Sex eligibility

All sexes

Study type

Observational

Primary location

State University of New York at Buffalo, Farber Hall

Buffalo, New York, 14214, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Lactating women (for breast milk sample)

Exclusion criteria

None

Treatment and study plan

Microbiome

Other

Primary outcomes

Difference in intestinal microbiome between gold standard and proposed field protocol

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study title

The Neonatal Microbiome Study: Validity of Biologic Sample Collection Methods

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2017
First posted: Jan 14, 2016
Registry last updated: Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed