Neonatal Microbiome Validity Study | NCT02655250

Studies
Neonatal Microbiome Validity Study

NCT02655250

Sponsor

State University of New York at Buffalo

Status

Completed

Last Update Posted

Oct 27, 2020Actual

Enrollment

5Actual

Phase

Not provided

Conditions

Gut Microbiome

Interventions

Microbiome

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015Actual

Primary Completion Date

Aug 2016Actual

Completion Date

Dec 2017Actual

First Submitted Date

Jun 19, 2015

First Submission Date that Met QC Criteria

Jan 11, 2016

First Posted Date

Jan 14, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2020

Last Update Posted Date

Oct 27, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amy E. Millen, Principal Investigator, State University of New York at BuffaloPrincipal Investigator

Lead Sponsor

State University of New York at BuffaloOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

5Actual

Name	Type	Description	Arm Group Labels	Other Names
Microbiome	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Lactating women (for breast milk sample)

Exclusion Criteria:

None

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amy E Millen, PhD	State University of New York at Buffalo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
State University of New York at Buffalo, Farber Hall		Buffalo	New York	14214	United States

Intervention Browse Module

MeSH Terms

ID	Term
D064307	Microbiota

Ancestor Terms

ID	Term
D008827	Microbiological Phenomena
D058448	Biota
D044822	Biodiversity
D017753	Ecosystem

Browse Leaves

Not provided

Browse Branches

Not provided