The FibreGum Study - Changing the Course of Obesity in Children (NCT05540678) | Clinical Trial Compass
TerminatedNot Applicable
The FibreGum Study - Changing the Course of Obesity in Children
Stopped: Based on the Intention To Treat interim analysis results and the slow recruitment rate.
Switzerland93 participantsStarted 2022-11-30
Plain-language summary
The aim of this study is thus to assess the effect of a chewing gum containing fibres on body weight, metabolism and the oral and intestinal microbiomes in a population of obese children.
Who can participate
Age range10 Years – 16 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Informed Consent according to International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (ICH/GCP) regulations prior to any study specific procedures
* Obesity as determined by a BMI ≥97th percentile using the Swiss paediatric, age- and sex-matched growth charts
* Newly referred within the last month to a tertiary weight management clinic
* Participant willing to use the study specific monitoring app on his/her own or legal representatives' smartphone
Exclusion Criteria:
* Antibiotic administration in the last 6 months
* Pre- or probiotic treatment in the last 6 weeks
* Any professionally supervised treatment for weight management within the last year
* Consumption of more than one nicotine product per month (e.g. cigarette, gum)
* Adolescent females: any stages of known pregnancy or lactation period
* Congenital disorder affecting the cardiovascular, hepatic or respiratory system in a relevant way (as per PI's or specialist's evaluation)
* Malignant disease on treatment or previous tumour affecting the appetite system (e.g., suprasellar, hypothalamic tumours)
* Systemic antibiotic or anti-inflammatory medication (e.g. systemic intake of glucocorticoids) over the last 7 days
* Known eating disorder (medically diagnosed)
* Participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation
* Dependency from…