GLP-1NCT07130396
Impact of Multivitamin (PhytoMulti®) and a Probiotic (UltraFlora® Balance Probiotic) on Gut Health of People Taking GLP-1 Medication
A study testing Multivitamin and a Probiotic in people with GLP-1 and Adults, run by Metagenics, Inc..
Trial summary
This is a single-arm, open-label clinical trial involving 100 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?
- Multivitamin and a Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to 30 Apr 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
- Minimum 4 weeks on GLP-1 (f.e Ozempic®, Wegovy®, Mounjaro®, etc.) and maximum 1 year on GLP-1
- Body Mass Index (BMI) ≥ 25 AND ≤ 30
- 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
- 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 used any antibiotic treatment in the 2 months prior to enrollment.
- Having a known allergy to the ingredients in the study product.
- Being pregnant or lactating (breastfeeding) or trying to become pregnant.
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- Participating in another clinical trial.
- Suffering from dementia or inability to take the trial treatment in an appropriate way.
- Taking PhytoMulti® Multivitamin and/or UltraFlora® Probiotic 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 Single Arm Trial to Evaluate the Effect of PhytoMulti® Multivitamin and UltraFlora® Balance Probiotic on Bowel Symptoms in Individuals Using GLP-1 Receptor Agonists, Assessed by the IBS Symptom Severity Score (IBS-SSS)
This is a single-arm, open-label clinical trial involving 100 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 PhytoMulti® Multivitamin at a fixed dose of 2 tablets per day and UltraFlora® Balance Probiotic at a fixed dose of 1 capsule per day, both administered orally once daily with food. During the 12-week treatment period, participants will be asked to complete questions at fixed timepoints.
- Being tested
- Multivitamin and a Probiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multivitamin and a ProbioticDietary 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 the study products (PhytoMulti® Multivitamin, 2 tablets/day and UltraFlora® Balance Probiotic, 1 capsule/day) are taken daily with breakfast
| Study group | Role | What they receive |
|---|---|---|
| PhytoMulti® Multivitamin and UltraFlora® Balance Probiotic arm | Active comparator | Not described Receives: Dietary Supplement: Multivitamin and a Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS- SSS
To assess impact of PhytoMulti® multivitamin and UltraFlora® Balance Probiotic on abdominal symptoms using the IBS severity scoring system (IBS-SSS)
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 posted19 Aug 2025
- Study start1 Nov 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GLP-1Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT07130396
- Sponsor's protocol ID
- GLO-NAM-2025-02
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 19 Aug 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 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Trial to Evaluate the Effect of PhytoMulti® Multivitamin and UltraFlora® Balance Probiotic on Bowel Symptoms in Individuals Using GLP-1 Receptor Agonists, Assessed by the IBS Symptom Severity Score (IBS-SSS)
- ClinicalTrials.gov ID
- NCT07130396
- Acronym / sponsor ID
- GLO-NAM-2025-02
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Metagenics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 19 Aug 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 single-arm, open-label clinical trial involving 100 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 PhytoMulti® Multivitamin at a fixed dose of 2 tablets per day and UltraFlora® Balance Probiotic at a fixed dose of 1 capsule per day, both administered orally once daily with food. During the 12-week treatment period, participants will be asked to complete questions at fixed timepoints.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PhytoMulti® Multivitamin and UltraFlora® Balance Probiotic arm | Active comparator | Dietary Supplement: Multivitamin and a Probiotic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Providing written informed consent
- Males and females of at least 18 years old
- Minimum 4 weeks on GLP-1 (f.e Ozempic®, Wegovy®, Mounjaro®, etc.) and maximum 1 year on GLP-1
- Body Mass Index (BMI) ≥ 25 AND ≤ 30
- Being willing to maintain stable dietary habits and physical activity levels throughout the trial period
Key exclusion criteria (9 listed)
- 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 used any antibiotic treatment in the 2 months prior to enrollment.
- Having a known allergy to the ingredients in the study product.
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 |
|---|---|---|
| Multivitamin and a ProbioticThe 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 (PhytoMulti® Multivitamin, 2 tablets/day and UltraFlora® Balance Probiotic, 1 capsule/day) are taken daily with breakfast | Dietary supplement | PhytoMulti® Multivitamin and UltraFlora® Balance Probiotic arm |
Primary outcome
IBS- SSS
Time frame: From enrollment to the end of treatment at 12 weeks (90 days)
To assess impact of PhytoMulti® multivitamin and UltraFlora® Balance Probiotic on abdominal symptoms using the IBS severity scoring system (IBS-SSS)
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 19 Aug 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 Multivitamin and a Probiotic in people with GLP-1 and Adults, 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 6 inclusion and 9 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 19 Aug 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. 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 (+1 800-843-9660, trials@metagenics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBS- SSS (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 19 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.