Metabolome and Microbiomic in Fecal Samples (MicroMet)

This study has been completed.
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00938028
First received: July 9, 2009
Last updated: July 17, 2009
Last verified: July 2009
  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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   12 Months to 20 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Harland Winter, MD, MassGeneral Hospital for Children
ClinicalTrials.gov Identifier: NCT00938028     History of Changes
Other Study ID Numbers: 2009p-000636
Study First Received: July 9, 2009
Last Updated: July 17, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 15, 2014