Appetite Regulation in Children With Failure to Thrive

Completed

• Conditions: Failure to Thrive

• Registration Number: NCT02647580
• Lead Sponsor: Lena Kirchner Brahe

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-21
• Study First Submitted QC: 2016-01-04
• Study First Posted: 2016-01-06
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-24
• Last Update Posted: 2017-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark