Failure to ThriveNCT02647580
Appetite Regulation in Children With Failure to Thrive
An observational study of Failure to Thrive, run by Lena Kirchner Brahe at 1 site in Denmark.
Trial summary
Failure to thrive (FTT) is an expression for inadequate growth in the early childhood and thus, a sign of undernutrition. This study will include children with FTT, and compare with existing data from children with normal and excessive growth. Read more about this study
- Who is it for?
- Ages 12 to 36 months
- Conditions the study is for
- Failure to Thrive
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2015to Jun 2017
- 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 36 months
- All sexes
- No healthy volunteers
- Child
Study population: Children with failure to thrive
Who may be able to join
- Diagnosed with failure to thrive
- Weight for height > 1.9 SD below the median by use of the WHO Child Growth Standards
- Age between 12-36 months
Who cannot join
- Cancer
- Inflammatory bowel disease
- Celiac disease
- Immunodeficiency
- Other somatic disease that can explain the growth failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Appetite-regulating Hormones, the Gut Microbiome and the Metabolome in Children With Failure to Thrive
Failure to thrive (FTT) is an expression for inadequate growth in the early childhood and thus, a sign of undernutrition. This study will include children with FTT, and compare with existing data from children with normal and excessive growth.
The overall aim of this study is to explore whether 1) children who develop FTT with no organic explanation differ from healthy normal weight and overweight children in their basal level of appetite-regulating hormones and 2) if inadequate, normal and excessive growth in children can be partly predicted by variation in their gut microbiome and metabolome.
- Conditions
- Failure to Thrive
- Keywords
- Growth, Children, Appetite-regulating hormones, Gut Microbiota
- Medical subject headings
- Failure to Thrive
What is being measured
The primary outcome is the main question the study is designed to answer.
Appetite-regulating hormones (ghrelin, PYY, leptin) measured by fasting blood samples
Measured: At subject enrollment
Secondary outcomes (7)
Microbiota composition measured by fecal samples
Measured: At subject enrollment
Metabolome measured by urine samples
Measured: At subject enrollment
Metabolic markers (insulin, glucose) measured by fasting blood samples
Measured: At subject enrollment
Body weight measured in kilograms
Measured: At subject enrollment
Height measured in centimeters
Measured: At subject enrollment
Head circumference measured in centimeters
Measured: At subject enrollment
Waist circumference measured in centimeters
Measured: At subject enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failure to ThriveStudies of the same condition, open and under way.
- 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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lena Kirchner Brahe
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital, Technical University of Denmark
- Responsible party
- Sponsor-investigator, Lena Kirchner Brahe, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647580
- Sponsor's protocol ID
- M229
- Status last verified
- Jul 2017
- First submitted
- 21 Dec 2015
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appetite-regulating Hormones, the Gut Microbiome and the Metabolome in Children With Failure to Thrive
- ClinicalTrials.gov ID
- NCT02647580
- Acronym / sponsor ID
- M229
- Conditions
- Failure to Thrive
- Keywords
- Growth, Children, Appetite-regulating hormones, Gut Microbiota
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Lena Kirchner BraheUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital, Technical University of Denmark
- Study start
- Dec 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 6 Jan 2016 (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.
Failure to thrive (FTT) is an expression for inadequate growth in the early childhood and thus, a sign of undernutrition. This study will include children with FTT, and compare with existing data from children with normal and excessive growth.
The overall aim of this study is to explore whether 1) children who develop FTT with no organic explanation differ from healthy normal weight and overweight children in their basal level of appetite-regulating hormones and 2) if inadequate, normal and excessive growth in children can be partly predicted by variation in their gut microbiome and metabolome.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with failure to thrive
Key inclusion criteria (3 listed)
- Diagnosed with failure to thrive
- Weight for height > 1.9 SD below the median by use of the WHO Child Growth Standards
- Age between 12-36 months
Key exclusion criteria (5 listed)
- Cancer
- Inflammatory bowel disease
- Celiac disease
- Immunodeficiency
- Other somatic disease that can explain the growth failure
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
Appetite-regulating hormones (ghrelin, PYY, leptin) measured by fasting blood samples
Time frame: At subject enrollment
7 secondary outcomes
Microbiota composition measured by fecal samples
Time frame: At subject enrollment
Metabolome measured by urine samples
Time frame: At subject enrollment
Metabolic markers (insulin, glucose) measured by fasting blood samples
Time frame: At subject enrollment
Body weight measured in kilograms
Time frame: At subject enrollment
Height measured in centimeters
Time frame: At subject enrollment
Head circumference measured in centimeters
Time frame: At subject enrollment
Waist circumference measured in centimeters
Time frame: At subject enrollment
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 25 Jul 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Failure to Thrive, run by Lena Kirchner Brahe at 1 site in Denmark.
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 3 inclusion and 5 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 25 Jul 2017. 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 Denmark. 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?
Appetite-regulating hormones (ghrelin, PYY, leptin) measured by fasting blood samples (time frame: At subject enrollment). 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 25 Jul 2017.