The FibreGum Study - Changing the Course of Obesity in Children

Insel Gruppe AG, University Hospital Bern

Status: Enrolling

Conditions: Adolescent Obesity; Child Obesity; Nutritional and Metabolic Diseases

Treatments: Dietary Supplement: FibreGum; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05540678

FibreGum

Details and patient eligibility

About

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.

Enrollment: 105 estimated patients

Sex: All

Ages: 10 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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105 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Chewing gum containing maltitol powder

Treatment:

Dietary Supplement: Placebo

Investigational

Experimental group

Description:

chewing gums containing fibers

Treatment:

Dietary Supplement: FibreGum

No-treatment control

No Intervention group

Description:

No study chewing gum