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Completed

NCT Number: NCT02647580

Appetite Regulation 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.

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Key information

Conditions

Failure to Thrive Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 month–36 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Appetite-regulating hormones (ghrelin, PYY, leptin) measured by fasting blood samples

    Time frame: At subject enrollment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Lena Kirchner Brahe

Other

Collaborators

  • Hvidovre University Hospital
  • Technical University of Denmark

Registry information

Official study title

Appetite-regulating Hormones, the Gut Microbiome and the Metabolome in Children With Failure to Thrive

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 6, 2016
Registry last updated
Jul 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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