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Metabolome and Microbiomic in Fecal Samples (MicroMet)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00938028
First Posted: July 13, 2009
Last Update Posted: July 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Massachusetts General Hospital
  Purpose
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.

Condition
Infant

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Fecal Samples for Metabolomic and Microbiomic Studies: Effects of Preparation and Storage

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Microbiome and metabolome yield [ Time Frame: one month ]

Biospecimen Retention:   None Retained
Stool samples

Enrollment: 4
Study Start Date: April 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Microbiome, Metabolome, Stool, Toddler
healthy infant stool samples

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 20 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy toddlers in a day care center
Criteria

Inclusion Criteria:

  • healthy
  • age 12-20 months
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00938028


Locations
United States, Massachusetts
MassGeneral for Children
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Harland Winter, MD MGH
  More Information

Responsible Party: Harland Winter, MD, MassGeneral Hospital for Children
ClinicalTrials.gov Identifier: NCT00938028     History of Changes
Other Study ID Numbers: 2009p-000636
First Submitted: July 9, 2009
First Posted: July 13, 2009
Last Update Posted: July 21, 2009
Last Verified: July 2009

Keywords provided by Massachusetts General Hospital:
microbiome
metabolome
stool
fecal samples
handling
toddler