Appetite Regulation in Children With Failure to Thrive | NCT02647580

Studies
Appetite Regulation in Children With Failure to Thrive

NCT02647580

Sponsor

Lena Kirchner Brahe

Status

Completed

Last Update Posted

Jul 25, 2017Actual

Enrollment

45Actual

Phase

Not provided

Conditions

Failure to Thrive

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015Actual

Primary Completion Date

Jun 2017Actual

Completion Date

Jun 2017Actual

First Submitted Date

Dec 21, 2015

First Submission Date that Met QC Criteria

Jan 4, 2016

First Posted Date

Jan 6, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2017

Last Update Posted Date

Jul 25, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lena Kirchner Brahe, Assistant professor, PhD, University of CopenhagenSponsor-Investigator

Lead Sponsor

Lena Kirchner BraheOTHER

Collaborators

Name	Class
Hvidovre University Hospital	OTHER
Technical University of Denmark	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

45Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Appetite-regulating hormones (ghrelin, PYY, leptin) measured by fasting blood samples		At subject enrollment

Secondary Outcomes

Measure	Description	Time Frame
Microbiota composition measured by fecal samples		At subject enrollment
Metabolome measured by urine samples		At subject enrollment
Metabolic markers (insulin, glucose) measured by fasting blood samples

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Months

Maximum Age

36 Months

Standard Ages

Child

Study Population

Children with failure to thrive

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hvidovre University Hospital		Hvidovre		2650	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D005183	Failure to Thrive

Ancestor Terms

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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