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Metabolome and Microbiomic in Fecal Samples (MicroMet)

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ClinicalTrials.gov Identifier: NCT00938028
Recruitment Status : Completed
First Posted : July 13, 2009
Last Update Posted : July 21, 2009
Sponsor:
Information provided by:

Study Description
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.

Condition or disease
Infant

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.


Study Design

Study Type : Observational
Actual Enrollment : 4 participants
Time Perspective: Prospective
Official Title: Fecal Samples for Metabolomic and Microbiomic Studies: Effects of Preparation and Storage
Study Start Date : April 2009
Primary Completion Date : May 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Microbiome, Metabolome, Stool, Toddler
healthy infant stool samples


Outcome Measures

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

Biospecimen Retention:   None Retained
Stool samples

Eligibility Criteria

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 Posted: July 13, 2009    Key Record Dates
Last Update Posted: July 21, 2009
Last Verified: July 2009

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