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NCT00938028 Clinical Trial

Metabolome and Microbiomic in Fecal Samples

Infant Clinical Trial

— MicroMet  

Official title:
Fecal Samples for Metabolomic and Microbiomic Studies: Effects of Preparation and Storage

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00938028
Other study ID # 2009p-000636
Secondary ID
Status Completed
Phase N/A
First received July 9, 2009
Last updated July 17, 2009
Start date April 2009
Est. completion date May 2009

Study information
Verified date July 2009
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 4
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Months to 20 Months
Eligibility Inclusion Criteria:

- healthy

- age 12-20 months

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States MassGeneral for Children Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Microbiome and metabolome yield one month No
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