Overview

This trial is active, not recruiting.

Condition microbiota
Treatment microbiome
Sponsor State University of New York at Buffalo
Start date September 2015
End date February 2016
Trial size 5 participants
Trial identifier NCT02655250, 758632-1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Difference in intestinal microbiome between gold standard and proposed field protocol
time frame: Baseline
Difference in breast milk microbiome between gold standard and proposed field protocol
time frame: Baseline

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Lactating women (for breast milk sample) Exclusion Criteria:

Additional Information

Official title The Neonatal Microbiome Study: Validity of Biologic Sample Collection Methods
Principal investigator Amy E Millen, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by State University of New York at Buffalo.