AdultsNCT07209046
Impact of Probiotic (UltraFlora® Triplebiotic) on Weight Evolution on People After Discontinuation of GLP-1 Treatment.
A study testing UltraFlora® Triplebiotic in people with Adults and GLP-1, run by Metagenics, Inc..
Trial summary
This is a randomized, double-blind, double arm study involving 128 participants who will undergo a total participation period of 12 weeks. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- UltraFlora® Triplebiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Providing written informed consent
- Males and females of at least 18 years old
- Body mass index (BMI) between 25 and 30 (including 25 and 30) (Weight: 25 < BMI < 30)
- Having undergone treatment with GLP-1 for more than 3 months but for less than 1 year.
- Having stopped GLP-1 treatment for a maximum of 4 weeks
- Being willing to maintain stable dietary habits and physical activity levels throughout the trial period
- 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).
Who cannot join
- Being on GLP-1 treatment
- Having had any type of bariatric surgery, or planned bariatric surgery during the period of trial participation.
- 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.
- Suffering from any uncontrolled endocrine disorder.
- Having consumed any probiotic supplements in the 3 months prior to enrollment.
- Having used any antibiotic treatment in the 3 months prior to enrollment.
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- Having a known allergy to the ingredients in the study product.
- Being pregnant or lactating (breastfeeding) or trying to become pregnant.
- Participating in an other clinical trial.
- Suffering from dementia or inability to take the trial treatment in an appropriate way.
- Taking UltraFlora® Triplebiotic or any similar product from competitors prior to trial participation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
This is a randomized, double-blind, double arm study involving 128 participants who will undergo a total participation period of 12 weeks.
Read the detailed description
The trial begins with a screening to assess eligibility, followed by a 12-week treatment phase during which participants will receive a fixed-dose oral supplementation regimen. During this treatment period, participants will take UltraFlora® Triplebiotic at a fixed dose of 2 capsule per day, administered orally once daily with food. During the 12-week treatment period, participants will be asked to complete questions and track their weight changes.
- Being tested
- UltraFlora® Triplebiotic, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltraFlora® TriplebioticDietary supplement
The duration of trial intervention and participation for an individual participant is approximately 3 months (12 weeks). Screening, during which eligibility to participate in the trial is assessed, occurs at baseline. A fixed, orally administered, dose of probiotic ( UltraFlora® Triplebiotics, 2 capsules/day) are taken daily with a glass of water.
PlaceboDietary supplement
The duration of trial intervention and participation for an individual participant is approximately 3 months (12 weeks). Screening, during which eligibility to participate in the trial is assessed, occurs at baseline. A fixed, orally administered, dose of placebo (2 capsule/day) are taken daily with a glass of water.
| Study group | Role | What they receive |
|---|---|---|
| UltraFlora® Triplebiotic | Active comparator | The duration of trial intervention and participation for an individual participant is approximately 3 months (12 weeks). Screening, during which eligibility to participate in the trial is assessed, occurs at baseline. A fixed, orally administered, dose of the study products (UltraFlora® Triplebiotic, 2 capsules/day) are taken daily with breakfast. Receives: Dietary Supplement: UltraFlora® Triplebiotic |
| Orally administration of 2 capsules/day of placebo | Placebo comparator | The duration of trial intervention and participation for an individual participant is approximately 3 months (12 weeks). Screening, during which eligibility to participate in the trial is assessed, occurs at baseline. A fixed, orally administered, dose of the placebo (2 capsules/day) are taken daily with breakfast. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight measurement
Evaluate the impact of UltraFlora Triplebiotic (containing Bifidobacterium Lactis B420 and pasteurized Akkermansia Muciniphila) on weight regain over 3 months after discontinuation of GLP-1.
Measured: From enrollment to the end of treatment at 12 weeks (90 days)
Secondary outcomes (3)
IBS-SSS (Irritable Bowel Syndrome - Severity Scoring System) questionnaire
Evaluate the impact of UltraFlora Triplebiotic containing Bifidobacterium Lactis B420 and pasteurized Akkermansia Muciniphila on weight regain over 3 months after discontinuation of GLP-1. It is a visual analog scale ranging from 0 to 100 that allows the severity of patients' gastrointestinal symptoms to be assessed. The higher the score, the more pain the patient is experiencing.
Measured: From enrollment to the end of treatment at 12 weeks (90 days)
SVS (Subjective Vitality Scale) questionnaire
Evaluate the impact of UltraFlora Triplebiotic containing Bifidobacterium Lactis B420 and pasteurized Akkermansia Muciniphila on vitality using the Subjective Vitality Scales (SVS) questionnaire. This questionnaire assesses a state of well-being and optimal functioning in relation to independence and physical and psychological health. Scores range from 1 (very low vitality) to 7 (optimal vitality).
Measured: From enrollment to the end of treatment at 12 weeks (90 days)
TFEQ-R18 (Three-Factor Eating Questionnaire - Revised 18 items) Questionnaire
Evaluate the impact of UltraFlora Triplebiotic containing Bifidobacterium Lactis B420 and pasteurized Akkermansia Muciniphila on Hunger, Appetite and Cravings using the TFEQ-R18 Questionnaire over the course of 90 days. The TFEQ-R18 is a psychometric questionnaire that assesses eating behaviors and attitudes toward food. There are three dimensions: CR = conscious restraint, UE = uncontrolled eating, EE = emotional eating. High scores in UE or EE indicate an increased risk of overeating, weight gain, or eating disorders. A high score in CR shows a strong desire to restrict intake, but this is sometimes associated with episodes of disinhibition if the restriction fails.
Measured: From enrollment to the end of treatment at 12 weeks (90 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start1 Nov 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdultsStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Metagenics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mieke Van Den Driessche, PhD, Study director, Metagenics, Inc.Irfan Qureshi, MD, Principal investigator, Metagenics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209046
- Sponsor's protocol ID
- GLO-NAM-2025-04
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 6 Oct 2025
- 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 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07209046
- Acronym / sponsor ID
- GLO-NAM-2025-04
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Metagenics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 6 Oct 2025 (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.
This is a randomized, double-blind, double arm study involving 128 participants who will undergo a total participation period of 12 weeks.
Detailed description
The trial begins with a screening to assess eligibility, followed by a 12-week treatment phase during which participants will receive a fixed-dose oral supplementation regimen. During this treatment period, participants will take UltraFlora® Triplebiotic at a fixed dose of 2 capsule per day, administered orally once daily with food. During the 12-week treatment period, participants will be asked to complete questions and track their weight changes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UltraFlora® Triplebiotic | Active comparator | Dietary Supplement: UltraFlora® TriplebioticThe duration of trial intervention and participation for an individual participant is approximately 3 months (12 weeks). Screening, during which eligibility to participate in the trial is assessed, occurs at baseline. A fixed, orally administered, dose of the study products (UltraFlora® Triplebiotic, 2 capsules/day) are taken daily with breakfast. |
| Orally administration of 2 capsules/day of placebo | Placebo comparator | Dietary Supplement: PlaceboThe duration of trial intervention and participation for an individual participant is approximately 3 months (12 weeks). Screening, during which eligibility to participate in the trial is assessed, occurs at baseline. A fixed, orally administered, dose of the placebo (2 capsules/day) are taken daily with breakfast. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Providing written informed consent
- Males and females of at least 18 years old
- Body mass index (BMI) between 25 and 30 (including 25 and 30) (Weight: 25 < BMI < 30)
- Having undergone treatment with GLP-1 for more than 3 months but for less than 1 year.
- Having stopped GLP-1 treatment for a maximum of 4 weeks
Key exclusion criteria (11 listed)
- Being on GLP-1 treatment
- Having had any type of bariatric surgery, or planned bariatric surgery during the period of trial participation.
- 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.
- Suffering from any uncontrolled endocrine disorder.
- Having consumed any probiotic supplements in the 3 months prior to enrollment.
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 |
|---|---|---|
| UltraFlora® TriplebioticThe duration of trial intervention and participation for an individual participant is approximately 3 months (12 weeks). Screening, during which eligibility to participate in the trial is assessed, occurs at baseline. A fixed, orally administered, dose of probiotic ( UltraFlora® Triplebiotics, 2 capsules/day) are taken daily with a glass of water. | Dietary supplement | UltraFlora® Triplebiotic |
| PlaceboThe duration of trial intervention and participation for an individual participant is approximately 3 months (12 weeks). Screening, during which eligibility to participate in the trial is assessed, occurs at baseline. A fixed, orally administered, dose of placebo (2 capsule/day) are taken daily with a glass of water. | Dietary supplement | Orally administration of 2 capsules/day of placebo |
Primary outcome
weight measurement
Time frame: From enrollment to the end of treatment at 12 weeks (90 days)
Evaluate the impact of UltraFlora Triplebiotic (containing Bifidobacterium Lactis B420 and pasteurized Akkermansia Muciniphila) on weight regain over 3 months after discontinuation of GLP-1.
3 secondary outcomes
IBS-SSS (Irritable Bowel Syndrome - Severity Scoring System) questionnaire
Time frame: From enrollment to the end of treatment at 12 weeks (90 days)
SVS (Subjective Vitality Scale) questionnaire
Time frame: From enrollment to the end of treatment at 12 weeks (90 days)
TFEQ-R18 (Three-Factor Eating Questionnaire - Revised 18 items) Questionnaire
Time frame: From enrollment to the end of treatment at 12 weeks (90 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- 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.
Mieke Van Den Driessche, PhD study director
Metagenics, Inc.
Irfan Qureshi, MD principal investigator
Metagenics, Inc.
Questions about this trial
What is this clinical trial studying?
A study testing UltraFlora® Triplebiotic in people with Adults and GLP-1, run by Metagenics, Inc..
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 7 inclusion and 11 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: opening soon, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Irfan Qureshi, MD (800-843-9660, trials@metagenics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight measurement (time frame: From enrollment to the end of treatment at 12 weeks (90 days)). 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 6 Oct 2025.