The FibreGum Study - Changing the Course of Obesity in Children

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Sep 12, 2022

Keywords

ClinConnect Summary

The FibreGum Study is a research trial aimed at helping children who are struggling with obesity. The main goal is to see how chewing a special gum that contains fibers can affect their body weight, metabolism (how their body uses energy), and the balance of healthy bacteria in their mouths and intestines. This study is currently looking for participants aged between 1 and 18 who are considered obese based on specific growth charts. To join, children need to have been recently referred to a weight management clinic and should be willing to use a monitoring app on a smartphone.

Participants in the study will chew the fiber gum and provide information through the app to help researchers understand its effects. However, there are some criteria that might prevent a child from participating, such as recent use of antibiotics, certain medical conditions, or being involved in other weight management treatments. This trial is an important step in finding new tools to combat obesity in children, and it could lead to helpful insights for families facing these challenges.

Gender

ALL

Eligibility criteria

• 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