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Not yet recruitingNCT07130396Updated Aug 19, 2025

Impact of Multivitamin (PhytoMulti®) and a Probiotic (UltraFlora® Balance Probiotic) on Gut Health of People Taking GLP-1 Medication

An interventional study of Multivitamin and a Probiotic in GLP-1 and Adults, sponsored by Metagenics, Inc.. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-19.

Sponsored by Metagenics, Inc. · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • GLP-1
  • Adults
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Providing written informed consent
  2. Males and females of at least 18 years old
  3. Minimum 4 weeks on GLP-1 (f.e Ozempic®, Wegovy®, Mounjaro®, etc.) and maximum 1 year on GLP-1
  4. Body Mass Index (BMI) ≥ 25 AND ≤ 30
  5. Being willing to maintain stable dietary habits and physical activity levels throughout the trial period
  6. 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

Exclusion Criteria:

  1. Having had any type of bariatric surgery, or planned bariatric surgery during the period of trial participation.
  2. 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.
  3. Suffering from any uncontrolled endocrine disorder
  4. Having used any antibiotic treatment in the 2 months prior to enrollment.
  5. Having a known allergy to the ingredients in the study product.
  6. Being pregnant or lactating (breastfeeding) or trying to become pregnant.
  7. Participating in another clinical trial.
  8. Suffering from dementia or inability to take the trial treatment in an appropriate way.
  9. Taking PhytoMulti® Multivitamin and/or UltraFlora® Probiotic or any similar product from competitors prior to trial participation
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    PhytoMulti® Multivitamin and UltraFlora® Balance Probiotic arm

    Dietary Supplement: Multivitamin and a Probiotic

Interventions

  • Dietary supplementMultivitamin and a Probiotic

    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

05

What researchers measure

Primary outcomes

  1. IBS- SSS

    To assess impact of PhytoMulti® multivitamin and UltraFlora® Balance Probiotic on abdominal symptoms using the IBS severity scoring system (IBS-SSS)

    Time frame: From enrollment to the end of treatment at 12 weeks (90 days)

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07130396
Lead sponsor
Metagenics, Inc.
Responsible party
Sponsor
First posted
Aug 19, 2025
Start date
Nov 1, 2025 (estimated)
Primary completion
Mar 31, 2026 (estimated)
Completion
Apr 30, 2026 (estimated)
Last update
Aug 19, 2025

Study contacts

Irfan Qureshi, MD
Contact
trials@metagenics.com
+1 800-843-9660
Mieke Van Den Driessche, PhD
study director · Metagenics, Inc.
Irfan Qureshi, MD
principal investigator · Metagenics, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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