The FibreGum Study - Changing the Course of Obesity in Children

Last updated: January 23, 2025
Sponsor: Insel Gruppe AG, University Hospital Bern
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Diabetes Prevention

Metabolic Disorders

Treatment

Placebo

FibreGum

Clinical Study ID

NCT05540678
FibreGum
  • Ages 10-16
  • All Genders

Study 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.

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

Total Participants: 105
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
November 30, 2022
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Kinderklinik Bern

    Berne, 3010
    Switzerland

    Active - Recruiting

  • Ostschweizer Kinderspital

    St. Gallen, 9000
    Switzerland

    Active - Recruiting

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