Neonatal Microbiome Validity Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Gut Microbiome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Microbiome

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Lactating women (for breast milk sample)

Exclusion Criteria

* None

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Amy E. Millen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amy E Millen, PhD

Role: PRINCIPAL_INVESTIGATOR

State University of New York at Buffalo

Locations

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State University of New York at Buffalo, Farber Hall

Buffalo, New York, United States

Site Status

Countries

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United States

Other Identifiers

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758632-1

Identifier Type: -

Identifier Source: org_study_id