Appetite-regulating Hormones, the Gut Microbiome and the Metabolome in Children With Failure to Thrive
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Appetite-regulating hormones (ghrelin, PYY, leptin) measured by fasting blood samples
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 12 Months to 36 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Inflammatory bowel disease
- •Celiac disease
- •Immunodeficiency
- •Other somatic disease that can explain the growth failure
Outcomes
Primary Outcomes
Appetite-regulating hormones (ghrelin, PYY, leptin) measured by fasting blood samples
Time Frame: At subject enrollment
Secondary Outcomes
- 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)
Investigators
Lena Kirchner Brahe
Assistant professor, PhD
University of Copenhagen