NCT00938028

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 13, 2009

Completed
Last Updated

July 21, 2009

Status Verified

July 1, 2009

Enrollment Period

1 month

First QC Date

July 9, 2009

Last Update Submit

July 17, 2009

Conditions

Infant

Keywords

microbiomemetabolomestoolfecal sampleshandlingtoddler

Outcome Measures

Primary Outcomes (1)

  • Microbiome and metabolome yield

    one month

Study Arms (1)

Microbiome, Metabolome, Stool, Toddler

healthy infant stool samples

Eligibility Criteria

Age12 Months - 20 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Healthy toddlers in a day care center

You may qualify if:

  • healthy
  • age 12-20 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MassGeneral for Children

Boston, Massachusetts, 02114, United States

Location

Biospecimen

Retention: NONE RETAINED

Stool samples

Study Officials

  • Harland Winter, MD

    MGH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 9, 2009

First Posted

July 13, 2009

Study Start

April 1, 2009

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

July 21, 2009

Record last verified: 2009-07

Locations

US(1)