Metabolome and Microbiomic in Fecal Samples | NCT00938028

Studies
Metabolome and Microbiomic in Fecal Samples

NCT00938028

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Jul 21, 2009Estimated

Enrollment

4Actual

Phase

Not provided

Conditions

Infant

Interventions

Not provided

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

Jul 2009

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

Apr 2009

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Jul 9, 2009

First Submission Date that Met QC Criteria

Jul 10, 2009

First Posted Date

Jul 13, 2009Estimated

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

Jul 17, 2009

Last Update Posted Date

Jul 21, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to evaluate the effects of storage and handling on fecal samples collected for metabolomic, proteomic and microbiomic and analysis.

Detailed Description

Background

Human fecal collection for clinical or research studies usually occurs at the residence of the subject, an environment not equipped with measures to accommodate proper preparation and storage of samples for microbiome and metabolome analysis.

Aims

To evaluate the effects of storage and handling on fecal samples collected for metabolomic, proteomic and microbiomic and analysis.

Methods

Fecal samples will be collected within several minutes of voiding from healthy infants at the time of diaper change at day-care center.

Samples will be divided into 7 tubes, and subjected to different storage temperatures, before preforming microbial analysis by DNA sequencing, and metabolome analysis by H1NMR spectroscoty.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

4Actual

Label	Type	Description	Intervention Names
Microbiome, Metabolome, Stool, Toddler		healthy infant stool samples

Measure	Description	Time Frame
Microbiome and metabolome yield		one month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy
age 12-20 months

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Months

Maximum Age

20 Months

Standard Ages

Child

Study Population

Healthy toddlers in a day care center

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Harland Winter, MD	MGH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MassGeneral for Children		Boston	Massachusetts	02114	United States