Chewing gum to help reduce obesity in children
The FibreGum Study - Changing the Course of Obesity in Children
This study tests if a special chewing gum with fibers can help obese children lose weight and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 10 Years to 16 Years |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 2 sites (Berne and 1 other locations) |
| Trial ID | NCT05540678 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of a special chewing gum containing fibers on body weight, metabolism, and the microbiomes in obese children. Participants will be randomly assigned to receive either the FibreGum or a placebo. The study aims to determine if this intervention can lead to significant improvements in obesity-related health outcomes. Children will also use a monitoring app to track their progress throughout the study.
Who should consider this trial
Good fit: Ideal candidates are obese children with a BMI at or above the 97th percentile who have recently been referred to a weight management clinic.
Not a fit: Patients with recent antibiotic use, pre- or probiotic treatments, or those undergoing other weight management treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a novel, non-invasive method to help manage obesity in children.
How similar studies have performed: While the specific approach of using chewing gum for obesity management is novel, similar studies exploring dietary interventions for obesity have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Berne and 1 other locations
- Kinderklinik Bern — Berne, Switzerland (Recruiting)
- Ostschweizer Kinderspital — St. Gallen, Switzerland (Recruiting)
Study contacts
- Study coordinator: Marie-Aline Gérard, Dr.
- Email: marie-aline.gerard@dcberne.com
- Phone: +41782049811
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.