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 range
10 Years – 16 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.