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Neonatal Microbiome Validity Study

The Neonatal Microbiome Study: Validity of Biologic Sample Collection Methods

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02655250
Enrollment
5
Registered
2016-01-14
Start date
2015-10-31
Completion date
2017-12-31
Last updated
2020-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gut Microbiome

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.

Interventions

OTHERMicrobiome

Sponsors

State University of New York at Buffalo
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Lactating women (for breast milk sample)

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Difference in intestinal microbiome between gold standard and proposed field protocolBaselineComparison 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 protocolBaselineComparison of microbiome from snap-frozen sample to proposed field collection methods to determine which field method best correlates with the snap-frozen sample.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026