Appetite Regulation in Children With Failure to Thrive

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02647580

Enrollment

Registered

2016-01-06

Start date

2015-12-31

Completion date

2017-06-30

Last updated

2017-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Failure to Thrive

Keywords

Growth, Children, Appetite-regulating hormones, Gut Microbiota

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

12 Months to 36 Months

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Denmark

Outcome results