Impact of Probiotic (UltraFlora® Triplebiotic) on Weight Evolution on People After Discontinuation of GLP-1 Treatment.
A Randomized, Double-blind, Double-arm Study Conducted Directly With Consumers Via an App "Baritastic App", Evaluating the Efficacy of a Supplement Containing Bifidobacterium Lactis B420 and Pasteurized Akkermansia Muciniphila (UltraFlora® Triplebiotic) for 3 Months in Adults After Discontinuation of GLP-1 Treatment.
Lead sponsor
Asset
GLP-1 / incretin class catch-all
Listed sites
0
Recruiting sites
-
Estimated enrollment
128
Study population
-
Eligibility highlights
•BMI 25-30
Primary endpoint
•Weight measurement
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Who can enroll
Inclusion criteria
1. Providing written informed consent
2. Males and females of at least 18 years old
3. Body mass index (BMI) between 25 and 30 (including 25 and 30) (Weight: 25 < BMI < 30)
4. Having undergone treatment with GLP-1 for more than 3 months but for less than 1 year.
5. Having stopped GLP-1 treatment for a maximum of 4 weeks
6. Being willing to maintain stable dietary habits and physical activity levels throughout the trial period
7. Being willing not to introduce any other food supplements during the trial period (supplements used in the two weeks prior to enrolling in the trial and used consistently throughout are acceptable, except for probiotics).
Exclusion criteria
1. Being on GLP-1 treatment
2. Having had any type of bariatric surgery, or planned bariatric surgery during the period of trial participation.
3. Suffering from a severe chronic disease (e.g., cancer, HIV, hepatic or renal impairment, diabetes type I), inflammatory bowel disease (IBD), Coeliac Disease, and/or being immunocompromised.
4. Suffering from any uncontrolled endocrine disorder.
5. Having consumed any probiotic supplements in the 3 months prior to enrollment.
6. Having used any antibiotic treatment in the 3 months prior to enrollment.
7. Having a known allergy to the ingredients in the study product.
8. Being pregnant or lactating (breastfeeding) or trying to become pregnant.
9. Participating in an other clinical trial.
10. Suffering from dementia or inability to take the trial treatment in an appropriate way.
11. Taking UltraFlora® Triplebiotic or any similar product from competitors prior to trial participation
Endpoints (7)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
1 endpointweight measurement
Time frame:From enrollment to the end of treatment at 12 weeks (90 days)
descriptive
Patient-reported / QoL
5 endpointsIBS-SSS (Irritable Bowel Syndrome - Severity Scoring System) questionnaire
Time frame:From enrollment to the end of treatment at 12 weeks (90 days)
descriptive
SVS (Subjective Vitality Scale) questionnaire
Time frame:From enrollment to the end of treatment at 12 weeks (90 days)
descriptive
TFEQ-R18 (Three-Factor Eating Questionnaire - Revised 18 items) Questionnaire
Time frame:From enrollment to the end of treatment at 12 weeks (90 days)
descriptive
Assessment of appetite (e.g., number of meals) and food cravings (e.g., snacking or food preferences) in seven questions.
Time frame:From enrollment to the end of treatment at 12 weeks (90 days)
event count, event
patient satisfaction with product use and recommendation
Time frame:The proportion of participants that at day 90 (T4):
descriptive
Other (unclassified)
1 endpointSide effects experienced when taking the test product or placebo throughout the study (product tolerance)
Time frame:The proportion of participants at day 14 (T1), day 30 (T2), day 60 (T3), day 90 (T4),
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.