Clinical trial NCT05540678: The FibreGum Study - Changing the Course of Obesity in Children
Official title: The FibreGum Study - Changing the Course of Obesity in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nutritional and Metabolic Diseases
Child Obesity
Adolescent Obesity
Keywords: Obesity
Chewing gum
Galactooligosaccharides
GOS (Galactooligosaccharides)
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: DCB Research AG
First posted: 2022-09-15
Enrollment: 105
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Reduction in the Body Mass Index (BMI) Z-score
timeFrame: 6 months
Secondary outcomes:
measure: Fasting blood glucose change
timeFrame: 6 months
measure: Fasting insulin change
timeFrame: 6 months
measure: HOmeostatic Model Assessment of Insulin Resistance (HOMA-IR) index change
timeFrame: 6 months
measure: Hemoglobin A1c (HbA1c) change
timeFrame: 6 months
measure: Lipid-profiles change
timeFrame: 6 months
measure: Systolic and diastolic blood pressures changes
timeFrame: 6 months
measure: Differential blood count change
timeFrame: 6 months
measure: Calprotectin and lipocalin-2 change in stool
timeFrame: 6 months
measure: Oral health
timeFrame: 6 months
measure: Intestinal health
timeFrame: 6 months
measure: Descriptive analysis of treatment adherence using data from an adherence-tracking app
timeFrame: 6 months
measure: Alanine Aminotransferase (ALAT) change
timeFrame: 6 months
measure: Calcifediol (25OH-Vitamin D3) change
timeFrame: 6 months
measure: Thyroid-Stimulating Hormone (TSH) change
timeFrame: 6 months
measure: Ferritin change
timeFrame: 6 months
measure: Proteinuria
timeFrame: 6 months
Other outcomes:
Locations:
city: Berne
country: Switzerland
facility: Kinderklinik Bern
city: St. Gallen
country: Switzerland
facility: Ostschweizer Kinderspital
Study officials:
affiliation: Department of Biomedical Research, Children Clinic Berne, Inselspital, Bern University Hospital University of Bern
name: Maria Luisa Balmer, Prof. med.
role: STUDY_DIRECTOR
References: