Nutritional and Metabolic DiseasesFibreGumNCT05540678
The FibreGum Study - Changing the Course of Obesity in Children
A study testing FibreGum in people with Nutritional and Metabolic Diseases and Child Obesity, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Nutritional and Metabolic Diseases, Child Obesity, Adolescent Obesity
- What is being tested?
- FibreGum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 30 Nov 2022to 23 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Kinderklinik Bern
Bern, 3010
Ostschweizer Kinderspital
Sankt Gallen, 9000
About this study
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.
- Being tested
- FibreGum, Placebo
- Keywords
- Obesity, Chewing gum, Galactooligosaccharides, GOS (Galactooligosaccharides)
- Medical subject headings
- Nutritional and Metabolic Diseases, Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibreGumDietary supplement
To chew every day during a period of 6 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.
PlaceboDietary supplement
To chew every day during a period of 6 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Chewing gum containing maltitol powder Receives: Dietary Supplement: Placebo |
| Investigational | Experimental | chewing gums containing fibers Receives: Dietary Supplement: FibreGum |
| No-treatment control | No intervention | No study chewing gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the Body Mass Index (BMI) Z-score
Difference in the BMI Z-scores measured at study start and study completion
Measured: 6 months
Secondary outcomes (16)
Fasting blood glucose change
Differences in fasting blood glucose (mg/dL or mmol/L) between study completion and study start.
Measured: 6 months
Fasting insulin change
Differences in fasting insulin (mIU/mL) between study completion and study start.
Measured: 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.
Measured: 6 months
Hemoglobin A1c (HbA1c) change
Differences in HbA1c (mmol/mol) between study completion and study start.
Measured: 6 months
Lipid-profiles change
Differences in lipid-profiles (Cholesterol, Triglyceride, HDL, LDL in mg/dL) between study completion and study start.
Measured: 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.
Measured: 6 months
Differential blood count change
Differences differential blood count (Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils in %) between study completion and study start.
Measured: 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)
Measured: 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.
Measured: 6 months
Intestinal health
Changes in intestinal microbiota-composition as assessed by metagenome sequencing from stool samples
Measured: 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.
Measured: 6 months
Alanine Aminotransferase (ALAT) change
Differences in ALAT between study completion and study start.
Measured: 6 months
Calcifediol (25OH-Vitamin D3) change
Differences in Calcifediol between study completion and study start.
Measured: 6 months
Thyroid-Stimulating Hormone (TSH) change
Differences in TSH between study completion and study start.
Measured: 6 months
Ferritin change
Differences in ferritin between study completion and study start.
Measured: 6 months
Proteinuria
Differences in proteinuria between study completion and study start.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start30 Nov 2022
- Primary completion23 Jan 2026
- Study completion23 Jan 2026
Why it stopped: Based on the Intention To Treat interim analysis results and the slow recruitment rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional and Metabolic DiseasesStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- DCB Research AG
- Responsible party
- Sponsor
- Investigators
- Maria Luisa Balmer, Prof. med., Study director, Department of Biomedical Research, Children Clinic Berne, Inselspital, Bern University Hospital University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540678
- Sponsor's protocol ID
- FibreGum
- Acronym
- FibreGum
- Status last verified
- Feb 2026
- First submitted
- 5 Sep 2022
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The FibreGum Study - Changing the Course of Obesity in Children
- ClinicalTrials.gov ID
- NCT05540678
- Acronym / sponsor ID
- FibreGum / FibreGum
- Keywords
- Obesity, Chewing gum, Galactooligosaccharides, GOS (Galactooligosaccharides)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on the Intention To Treat interim analysis results and the slow recruitment rate.
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- DCB Research AG
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 23 Jan 2026 (actual)
- Study completion
- 23 Jan 2026 (actual)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboChewing gum containing maltitol powder |
| Investigational | Experimental | Dietary Supplement: FibreGumchewing gums containing fibers |
| No-treatment control | No intervention | –No study chewing gum |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FibreGumTo chew every day during a period of 6 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each. | Dietary supplement | Investigational |
| PlaceboTo chew every day during a period of 6 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each. | Dietary supplement | Placebo |
Primary outcome
Reduction in the Body Mass Index (BMI) Z-score
Time frame: 6 months
Difference in the BMI Z-scores measured at study start and study completion
16 secondary outcomes
Fasting blood glucose change
Time frame: 6 months
Fasting insulin change
Time frame: 6 months
HOmeostatic Model Assessment of Insulin Resistance (HOMA-IR) index change
Time frame: 6 months
Hemoglobin A1c (HbA1c) change
Time frame: 6 months
Lipid-profiles change
Time frame: 6 months
Systolic and diastolic blood pressures changes
Time frame: 6 months
Differential blood count change
Time frame: 6 months
Calprotectin and lipocalin-2 change in stool
Time frame: 6 months
Oral health
Time frame: 6 months
Intestinal health
Time frame: 6 months
Descriptive analysis of treatment adherence using data from an adherence-tracking app
Time frame: 6 months
Alanine Aminotransferase (ALAT) change
Time frame: 6 months
Calcifediol (25OH-Vitamin D3) change
Time frame: 6 months
Thyroid-Stimulating Hormone (TSH) change
Time frame: 6 months
Ferritin change
Time frame: 6 months
Proteinuria
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Based on the Intention To Treat interim analysis results and the slow recruitment rate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Luisa Balmer, Prof. med. study director
Department of Biomedical Research, Children Clinic Berne, Inselspital, Bern University Hospital University of Bern
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FibreGum in people with Nutritional and Metabolic Diseases and Child Obesity, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Based on the Intention To Treat interim analysis results and the slow recruitment rate.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the Body Mass Index (BMI) Z-score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.