NCT02647580

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 25, 2017

Status Verified

July 1, 2017

Enrollment Period

1.5 years

First QC Date

December 21, 2015

Last Update Submit

July 24, 2017

Conditions

Failure to Thrive

Keywords

GrowthChildrenAppetite-regulating hormonesGut Microbiota

Outcome Measures

Primary Outcomes (1)

  • Appetite-regulating hormones (ghrelin, PYY, leptin) measured by fasting blood samples

    At subject enrollment

Secondary Outcomes (7)

  • 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

    At subject enrollment

  • Body weight measured in kilograms

    At subject enrollment

  • Height measured in centimeters

    At subject enrollment

  • +2 more secondary outcomes

Eligibility Criteria

Age12 Months - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with failure to thrive

You may qualify if:

  • 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

You may not qualify if:

  • Cancer
  • Inflammatory bowel disease
  • Celiac disease
  • Immunodeficiency
  • Other somatic disease that can explain the growth failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum, feces, urine

MeSH Terms

Conditions

Failure to Thrive

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor, PhD

Study Record Dates

First Submitted

December 21, 2015

First Posted

January 6, 2016

Study Start

December 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

July 25, 2017

Record last verified: 2017-07

Locations

DK(1)