Neonatal Microbiome Validity Study

Gut Microbiome Clinical Trial

Official title:

The Neonatal Microbiome Study: Validity of Biologic Sample Collection Methods

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02655250
• Other study ID #: 758632-1
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Gut Microbiome

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