The FibreGum Study - Changing the Course of Obesity in Children (FibreGum)

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.

Study Overview

• Status: Terminated
• Conditions: Adolescent Obesity; Child Obesity; Nutritional and Metabolic Diseases
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: FibreGum

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Kinderklinik Bern
  • Sankt Gallen, Switzerland, 9000
    • Ostschweizer Kinderspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Chewing gum containing maltitol powder	Dietary supplement: Placebo; To chew every day during a period of 6 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.
Experimental: Investigational; chewing gums containing fibers	Dietary supplement: FibreGum; To chew every day during a period of 6 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.
No Intervention: No-treatment control; No study chewing gum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in the Body Mass Index (BMI) Z-score	Difference in the BMI Z-scores measured at study start and study completion	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting blood glucose change	Differences in fasting blood glucose (mg/dL or mmol/L) between study completion and study start.	6 months
Fasting insulin change	Differences in fasting insulin (mIU/mL) between study completion and study start.	6 months
HOmeostatic Model Assessment of Insulin Resistance (HOMA-IR) index change	Differences in Homeostatic Model Assessment of Insulin Resistance Index (min:0 - max:10) between study completion and study start. Lower scores mean better outcome.	6 months
Hemoglobin A1c (HbA1c) change	Differences in HbA1c (mmol/mol) between study completion and study start.	6 months
Lipid-profiles change	Differences in lipid-profiles (Cholesterol, Triglyceride, HDL, LDL in mg/dL) between study completion and study start.	6 months
Systolic and diastolic blood pressures changes	Differences in both systolic blood pressure and diastolic blood pressure (mm Hg) between study completion and study start.	6 months
Differential blood count change	Differences differential blood count (Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils in %) between study completion and study start.	6 months
Calprotectin and lipocalin-2 change in stool	Differences in calprotectin and lipocalin-2 (µg/g) in stool between study completion and study start as determined by Enzyme-Linked Immunosorbent Assay (ELISA)	6 months
Oral health	Changes in oral microbiota as assessed by 16S ribosomal ribonucleic acid (rRNA) gene sequencing from oral washes. Remark: The "S" in 16S is a sedimentation coefficient, that is, an index reflecting the downward velocity of the macromolecule in the centrifugal field.	6 months
Intestinal health	Changes in intestinal microbiota-composition as assessed by metagenome sequencing from stool samples	6 months
Descriptive analysis of treatment adherence using data from an adherence-tracking app	The assessment of adherence to chewing-gum will be assessed as percentage (%) of chewing-gums chewed.	6 months
Alanine Aminotransferase (ALAT) change	Differences in ALAT between study completion and study start.	6 months
Calcifediol (25OH-Vitamin D3) change	Differences in Calcifediol between study completion and study start.	6 months
Thyroid-Stimulating Hormone (TSH) change	Differences in TSH between study completion and study start.	6 months
Ferritin change	Differences in ferritin between study completion and study start.	6 months
Proteinuria	Differences in proteinuria between study completion and study start.	6 months

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Collaborators: DCB Research AG
• Investigators: Study Director: Maria Luisa Balmer, Prof. med., Department of Biomedical Research, Children Clinic Berne, Inselspital, Bern University Hospital University of Bern

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2022
• Primary Completion (Actual): January 23, 2026
• Study Completion (Actual): January 23, 2026

Study Registration Dates

• First Submitted: September 5, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; Chewing gum; Galactooligosaccharides; GOS (Galactooligosaccharides)
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Obesity; Pediatric Obesity; Nutritional and Metabolic Diseases
• Other Study ID Numbers: FibreGum

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No