The FibreGum Study - Changing the Course of Obesity in Children

The FibreGum Study - Changing the Course of Obesity in Children

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.

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 the sponsor or the clinical investigator
• Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, etc. of the participant and/or legal representative