The FaibaGo Study - Long-Term Weight Reduction Via Low-Threshold Intervention

Launched by UNIVERSITY OF BERN · Jun 16, 2025

Keywords

ClinConnect Summary

This clinical study, called the FaibaGo Study, is looking at whether chewing a special gum containing ingredients called galactooligosaccharides (GOS) can help adults who are overweight lose weight and improve their metabolism. The study will also explore how this gum affects the bacteria in the mouth and gut, which are important for overall health. The goal is to see if this simple approach can support long-term weight loss and better body function.

Adults aged 25 or older who have a Body Mass Index (BMI) over 25, meaning they are considered overweight, and who have at least one metabolic risk factor—such as slightly high blood sugar, liver enzymes, cholesterol, or triglycerides—may be eligible to join. Participants will need to be able to chew gum regularly and collect stool samples for the study, and they should have access to a smartphone or computer to follow the study steps. People with certain health conditions or recent treatments, like recent antibiotic use, diabetes requiring insulin, or recent weight loss surgeries, will not be able to take part. If you join, you can expect to chew the special gum over a period of time while researchers monitor your weight, metabolism, and the helpful bacteria in your body to understand the effects. This study is not yet open for enrollment but aims to find a simple, non-invasive way to support weight management.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Informed Consent (IC) according to ICH/GCP regulations prior to any study-specific procedures
• • Adults aged ≥ 25 years
• • Overweight as determined by a Body Mass Index \> 25 kg/m2
• * Metabolic risk factor: at least one of the following criteria:
• • i. HbA1c ≥ 5.7% ii. Elevated liver enzymes (ALAT, ASAT, Gamma-Glutamyltransferase (gGT) at least one above normal range of the assay used in the respective laboratory) iii. LDL-cholesterol \> 3.0 mmol/l iv. Triglycerides \> 1.7 mmol/l
• • Ability and willingness to follow the study protocol (e.g., cognitive capacity for compliance, gum chewing, faecal sample collection)
• • Access and willing to use an electronic device (e.g., mobile phone, computer or tablet)
• Exclusion Criteria:
• • Systemic antibiotic use within the last 2 months
• • History of bariatric surgery
• • Initiation or dose adjustment of pharmaceutical treatment for dyslipidemia or hyperglycemia within the last 3 months or during the study (e.g., metformin, statins, SGLT2 inhibitors)
• • Use of prebiotic or probiotic supplementation (duration \>1 month) within the last 6 weeks (at PI's discretion, based on medication summary of TP)
• • Medical weight management treatments within the last year (e.g., Glucagon-Like Peptide-1 (GLP-1) agonists)
• • Daily use of proton pump inhibitors (e.g., pantoprazole, omeprazole) during time of study
• • Professionally supervised intensive (\>6 months of ongoing supervision) weight management treatments (e.g., structured nutrition counselling) within the last year (at the PI's discretion)
• • Diagnosis of Type 1 or Type 2 diabetes requiring insulin therapy
• • Regular alcohol consumption exceeding two (women) or three (men) standard units (10 g of pure alcohol) per day
• • Consumption of more than one nicotine product (e.g., (e-)cigarette, gum) per month
• • Regular drug abuse (once per week over the past 4 months)
• • Any stage of known pregnancy or lactation period (self-reported)
• • Active cancer or recent cancer treatment (within the last 4 months)
• • Chronic, active inflammatory diseases (e.g., inflammatory bowel disease, rheumatoid arthritis)
• • Severe gastrointestinal disorders (e.g., celiac disease, short bowel syndrome, gastroparesis)
• • Known eating disorder (medically diagnosed)
• • Participation in another investigation with an investigational drug within the 30 days preceding randomisation
• • Dependency from the Sponsor-Investigator