Genetic Correlates of Wasting: a Pilot Study With Childre... | NCT04848129

Studies
Genetic Correlates of Wasting: a Pilot Study With Children Attending a Tertiary Feeding Clinic

NCT04848129

Sponsor

University of Glasgow

Status

Completed

Last Update Posted

Apr 7, 2022Actual

Enrollment

25Actual

Phase

Not provided

Conditions

Undernutrition
Eating Disorders
Underweight

Interventions

Feeding clinic

Countries

United Kingdom

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

Mar 2022

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

May 1, 2021Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Apr 13, 2021

First Submission Date that Met QC Criteria

Apr 13, 2021

First Posted Date

Apr 19, 2021Actual

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

Mar 29, 2022

Last Update Posted Date

Apr 7, 2022Actual

Name	Class
University of Stirling	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

This is a pilot study of children attending the Glasgow feeding clinic (GFC) which looks after a range of children with severe feeding problems who commonly have low appetite and extreme thinness. The investigators want to find out if these children are more likely to carry genetic markers of thinness.

Detailed Description

Thinness occurs as a result of undereating, but it is not always clear why an individual child has not eaten enough, or how to get them to eat more. There is a need to understand the child characteristics that predispose to undereating and the how these operate, in order to design more effective treatment and prevention programmes. The Glasgow feeding clinic (GFC) looks after a range of children with severe feeding problems who commonly have low appetite and extreme thinness. The investigators want to find out if these children are more likely to carry genetic markers of thinness.

The investigators will invite up to 60 families to complete a standardised online questionnaire (ICFET) about their child's eating behaviour and collect a saliva sample from their child, sent by post. The investigators will identify how many genetic markers for thinness each carries and relate this to their ICFET appetite scores and existing growth measurements as well as their feeding history.

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

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Feeding clinic	Behavioral	These children have all attended a multidisciplinary feeding clinic with severe food refusal and were commonly receiving tube feeding or supplement drinks. The clinic helps children progress onto a normal oral diet		tube weaning

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Genotype risk score	This the number of risk polymorphisms present for each child ranges from 0-20. a high score suggests more thinness	Within 1-2 months of recruitment

Secondary Outcomes

Measure	Description	Time Frame
Eating behaviour score	Measure of appetite and food refusal assessed using standard questionnaire (International Complementary Feeding Evaluation Tool (ICFET) Score from 1-5, hihger score suggests greater avidity	At recruitment or up to 2 months before
Body mass index

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All participants currently attending Glasgow Feeding Clinic or assessed there within the last 2 years. NB current ethical application is restricted to children aged 1-7 years, but the investigators plan to apply to extend that to age 16 years.

Exclusion Criteria:

Sample not to be collected with 2 weeks of any symptoms or recent contact with Covid 19

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

16 Years

Standard Ages

Child

Study Population

This is a heterogeneous population, united by their difficulties in eating solid food. The majority are, or have previously been, tube fed and around half have some learning disability. Thinness is very common in this group, but we will include all children, whatever their current growth pattern.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charlotte Wright, MD	University of Glasgow	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New Lister building, Royal Infirmary		Glasgow	Scotland	G31 2ER	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The individual anonymized data would be made available on request for a collaborative genetic study

Types

Study Protocol
Informed Consent Form (ICF)

Time Frame

On request once initial write up is complete - after 2 years

Access Criteria

Available on request

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D044342	Malnutrition
D001068	Feeding and Eating Disorders
D013851	Thinness
D005247	Feeding Behavior
D000080146	Avoidant Restrictive Food Intake Disorder

Ancestor Terms

ID	Term
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms

Browse Leaves

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Browse Branches

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