Appetite Regulation in Children With Failure to Thrive

Failure to Thrive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02647580
• Other study ID #: M229
• Status: Completed
• Phase: N/A
• First received: December 21, 2015
• Last updated: July 24, 2017
• Start date: December 2015
• Est. completion date: June 2017

Study information

• Verified date: July 2017
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Failure to Thrive

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (3)

Lead Sponsor	Collaborator
Lena Kirchner Brahe	Hvidovre University Hospital, Technical University of Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Appetite-regulating hormones (ghrelin, PYY, leptin) measured by fasting blood samples		At subject enrollment
Secondary	Microbiota composition measured by fecal samples		At subject enrollment
Secondary	Metabolome measured by urine samples		At subject enrollment
Secondary	Metabolic markers (insulin, glucose) measured by fasting blood samples		At subject enrollment
Secondary	Body weight measured in kilograms		At subject enrollment
Secondary	Height measured in centimeters		At subject enrollment
Secondary	Head circumference measured in centimeters		At subject enrollment
Secondary	Waist circumference measured in centimeters		At subject enrollment