Appetite Regulation in Children With Failure to Thrive

NCT ID: NCT02647580

Last Updated: 2017-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-06-30

Brief Summary

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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

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Conditions

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Failure to Thrive

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role collaborator

Technical University of Denmark

OTHER

Sponsor Role collaborator

Lena Kirchner Brahe

OTHER

Sponsor Role lead

Responsible Party

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Lena Kirchner Brahe

Assistant professor, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Hvidovre University Hospital

Hvidovre, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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M229

Identifier Type: -

Identifier Source: org_study_id

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