NCT02655250

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 14, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 27, 2020

Status Verified

October 1, 2020

Enrollment Period

10 months

First QC Date

June 19, 2015

Last Update Submit

October 23, 2020

Conditions

Gut Microbiome

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Interventions

MicrobiomeOTHER

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A convenience sample of men/women willing to provide a stool sample and/or breast milk sample.

You may qualify if:

  • Lactating women (for breast milk sample)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State University of New York at Buffalo, Farber Hall

Buffalo, New York, 14214, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool and breast milk samples will be collected. Bacterial DNA will be isolated and stored. Human DNA will not be retained in these samples.

MeSH Terms

Interventions

Microbiota

Intervention Hierarchy (Ancestors)

Microbiological PhenomenaBiotaBiodiversityEcosystemEnvironmentEcological and Environmental PhenomenaBiological PhenomenaEnvironment and Public Health

Study Officials

  • Amy E Millen, PhD

    State University of New York at Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 19, 2015

First Posted

January 14, 2016

Study Start

October 1, 2015

Primary Completion

August 1, 2016

Study Completion

December 1, 2017

Last Updated

October 27, 2020

Record last verified: 2020-10

Locations

US(1)