Clinical Trial: Appetite Regulation in Children With Failure to Thrive
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Appetite-regulating Hormones, the Gut Microbiome and the Metabolome in Children With Failure to Thrive
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 Summary:
Sponsor: Lena Kirchner Brahe
Current Primary Outcome: Appetite-regulating hormones (ghrelin, PYY, leptin) measured by fasting blood samples [ Time Frame: At subject enrollment ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Microbiota composition measured by fecal samples [ Time Frame: At subject enrollment ]
- Metabolome measured by urine samples [ Time Frame: At subject enrollment ]
- Metabolic markers (insulin, glucose) measured by fasting blood samples [ Time Frame: At subject enrollment ]
- Body weight measured in kilograms [ Time Frame: At subject enrollment ]
- Height measured in centimeters [ Time Frame: At subject enrollment ]
- Head circumference measured in centimeters [ Time Frame: At subject enrollment ]
- Waist circumference measured in centimeters [ Time Frame: At subject enrollment ]
Original Secondary Outcome: Same as current
Information By: University of Copenhagen
Dates:
Date Received: December 21, 2015
Date Started: December 2015
Date Completion: September 2017
Last Updated: October 25, 2016
Last Verified: October 2016
