Loading clinical trials...

The FibreGum Study - Changing the Course of Obesity in Children | Clinical Trials | Clareo Health

TERMINATEDNA

The FibreGum Study - Changing the Course of Obesity in Children

NCT05540678•Insel Gruppe AG, University Hospital Bern

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

Age

10 - 16 years

Sex

ALL

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
+2 more criteria

Locations (2)

Kinderklinik Bern

Bern, Switzerland

Ostschweizer Kinderspital

Sankt Gallen, Switzerland

Key Dates

Start Date

November 30, 2022

Primary Completion Date

January 23, 2026

Completion Date

January 23, 2026

Last Updated

February 18, 2026

Enrollment

ACTUAL participants

Conditions

Nutritional and Metabolic DiseasesChild ObesityAdolescent Obesity

Interventions

FibreGum

DIETARY_SUPPLEMENT

Placebo

DIETARY_SUPPLEMENT

Family COMIDA (Consumo de Opciones Más Ideales De Alimentos) (Eating More Ideal Food Options)

NCT07144800

ObesityChild Obesity+1 more

View study

RECRUITINGNA

Self-Weighing for Adolescents Seeking Obesity Treatment

NCT04837586

Adolescent Obesity

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

The FibreGum Study - Changing the Course of Obesity in Children

Inclusion Criteria

Exclusion Criteria

Family COMIDA (Consumo de Opciones Más Ideales De Alimentos) (Eating More Ideal Food Options)

Self-Weighing for Adolescents Seeking Obesity Treatment

Postprandial Glucose Levels, Gut Microbiota and Supplementation With Functional Foods in Adults

Dietary Modulation of Gut Microbiota in Overweight/Obese Adolescents and COVID-19 Infection

Attrition in Pediatric Obesity Management

Improving Sleep, Decision-Making, and Eating in Adolescents with Obesity