InfantMicroMetNCT00938028
Metabolome and Microbiomic in Fecal Samples
An observational study of Infant, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 20 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to May 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy toddlers in a day care center
Who may be able to join
- healthy
- age 12-20 months
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
MassGeneral for Children
Boston, Massachusetts, 02114
About this study
Official title: Fecal Samples for Metabolomic and Microbiomic Studies: Effects of Preparation and Storage
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.
Read the 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.
- Conditions
- Infant
- Keywords
- microbiome, metabolome, stool, fecal samples, handling, toddler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Microbiome, Metabolome, Stool, Toddler | healthy infant stool samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome and metabolome yield
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfantStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Harland Winter, MD, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00938028
- Sponsor's protocol ID
- 2009p-000636
- Acronym
- MicroMet
- Status last verified
- Jul 2009
- First submitted
- 9 Jul 2009
- Last updated
- 21 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Samples for Metabolomic and Microbiomic Studies: Effects of Preparation and Storage
- ClinicalTrials.gov ID
- NCT00938028
- Acronym / sponsor ID
- MicroMet / 2009p-000636
- Conditions
- Infant
- Keywords
- microbiome, metabolome, stool, fecal samples, handling, toddler
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 13 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microbiome, Metabolome, Stool, Toddler | – | –healthy infant stool samples |
Who may qualify
- Ages
- 12 to 20 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy toddlers in a day care center
Key inclusion criteria (2 listed)
- healthy
- age 12-20 months
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Microbiome and metabolome yield
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harland Winter, MD principal investigator
MGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome and metabolome yield (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2009.