Phase
Condition
Obesity
Diabetes Prevention
Metabolic Disorders
Treatment
Placebo
FibreGum
Clinical Study ID
Ages 10-16 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Informed Consent according to International Conference on Harmonisation of TechnicalRequirements for Registration of Pharmaceuticals for Human Use/Good ClinicalPractice (ICH/GCP) regulations prior to any study specific procedures
Obesity as determined by a BMI ≥97th percentile using the Swiss paediatric, age- andsex-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 legalrepresentatives' smartphone
Exclusion
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 arelevant 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 ofglucocorticoids) over the last 7 days
Known eating disorder (medically diagnosed)
Participation in another investigation with an investigational drug within the 30days 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 languageproblems, psychological disorders, etc. of the participant and/or legalrepresentative
Study Design
Connect with a study center
Kinderklinik Bern
Berne, 3010
SwitzerlandActive - Recruiting
Ostschweizer Kinderspital
St. Gallen, 9000
SwitzerlandActive - Recruiting
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