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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04848129
Other study ID # NHSGGC290906Gen
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date December 31, 2021

Study information

Verified date March 2022
Source University of Glasgow
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 1 Year to 16 Years
Eligibility 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

Study Design


Intervention

Behavioral:
Feeding clinic
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

Locations

Country Name City State
United Kingdom New Lister building, Royal Infirmary Glasgow Scotland

Sponsors (2)

Lead Sponsor Collaborator
University of Glasgow University of Stirling

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Body mass index weight (kg)/Height (m) squared Up to two years before genetic test
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