Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Appetite Regulation in Children With Failure to Thrive

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02647580
Recruitment Status : Completed
First Posted : January 6, 2016
Last Update Posted : July 25, 2017
Sponsor:
Collaborators:
Hvidovre University Hospital
Technical University of Denmark
Information provided by (Responsible Party):
Lena Kirchner Brahe, University of Copenhagen

Brief 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.

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.


Condition or disease
Failure to Thrive

Layout table for study information
Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Appetite-regulating Hormones, the Gut Microbiome and the Metabolome in Children With Failure to Thrive
Actual Study Start Date : December 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones




Primary Outcome Measures :
  1. Appetite-regulating hormones (ghrelin, PYY, leptin) measured by fasting blood samples [ Time Frame: At subject enrollment ]

Secondary Outcome Measures :
  1. Microbiota composition measured by fecal samples [ Time Frame: At subject enrollment ]
  2. Metabolome measured by urine samples [ Time Frame: At subject enrollment ]
  3. Metabolic markers (insulin, glucose) measured by fasting blood samples [ Time Frame: At subject enrollment ]
  4. Body weight measured in kilograms [ Time Frame: At subject enrollment ]
  5. Height measured in centimeters [ Time Frame: At subject enrollment ]
  6. Head circumference measured in centimeters [ Time Frame: At subject enrollment ]
  7. Waist circumference measured in centimeters [ Time Frame: At subject enrollment ]

Biospecimen Retention:   Samples With DNA
Plasma, serum, feces, urine


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with failure to thrive
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02647580


Locations
Layout table for location information
Denmark
Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Lena Kirchner Brahe
Hvidovre University Hospital
Technical University of Denmark

Layout table for additonal information
Responsible Party: Lena Kirchner Brahe, Assistant professor, PhD, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02647580     History of Changes
Other Study ID Numbers: M229
First Posted: January 6, 2016    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017

Keywords provided by Lena Kirchner Brahe, University of Copenhagen:
Growth
Children
Appetite-regulating hormones
Gut Microbiota

Additional relevant MeSH terms:
Layout table for MeSH terms
Failure to Thrive
Signs and Symptoms