Appetite Regulation in Children With Failure to Thrive

July 24, 2017 updated by: Lena Kirchner Brahe

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children with failure to thrive

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Cancer
  • Inflammatory bowel disease
  • Celiac disease
  • Immunodeficiency
  • Other somatic disease that can explain the growth failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Appetite-regulating hormones (ghrelin, PYY, leptin) measured by fasting blood samples
Time Frame: At subject enrollment
At subject enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
Microbiota composition measured by fecal samples
Time Frame: At subject enrollment
At subject enrollment
Metabolome measured by urine samples
Time Frame: At subject enrollment
At subject enrollment
Metabolic markers (insulin, glucose) measured by fasting blood samples
Time Frame: At subject enrollment
At subject enrollment
Body weight measured in kilograms
Time Frame: At subject enrollment
At subject enrollment
Height measured in centimeters
Time Frame: At subject enrollment
At subject enrollment
Head circumference measured in centimeters
Time Frame: At subject enrollment
At subject enrollment
Waist circumference measured in centimeters
Time Frame: At subject enrollment
At subject enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lena Kirchner Brahe

Collaborators

Hvidovre University Hospital
Technical University of Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

December 21, 2015

First Submitted That Met QC Criteria

January 4, 2016

First Posted (Estimate)

January 6, 2016

Study Record Updates

Last Update Posted (Actual)

July 25, 2017

Last Update Submitted That Met QC Criteria

July 24, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M229

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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