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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02647580
Other study ID # M229
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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