The FibreGum Study - Changing the Course of Obesity in Children
NCT ID: NCT05540678
Last Updated: 2025-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
105 participants
INTERVENTIONAL
2022-11-30
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Chewing gum containing maltitol powder
Placebo
To chew every day during a period of 6 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.
Investigational
chewing gums containing fibers
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-treatment control
No study chewing gum
No interventions assigned to this group
Interventions
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FibreGum
To chew every day during a period of 6 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.
Placebo
To chew every day during a period of 6 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
10 Years
16 Years
ALL
No
Sponsors
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DCB Research AG
OTHER
Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Maria Luisa Balmer, Prof. med.
Role: STUDY_DIRECTOR
Department of Biomedical Research, Children Clinic Berne, Inselspital, Bern University Hospital University of Bern
Locations
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Kinderklinik Bern
Bern, , Switzerland
Ostschweizer Kinderspital
Sankt Gallen, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FibreGum
Identifier Type: -
Identifier Source: org_study_id
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