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

Not Applicable

Not yet recruiting

• Conditions: GLP-1; Adults

• Registration Number: NCT07130396
• Lead Sponsor: Metagenics, Inc.

Brief Summary

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 Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-12
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-19
• Last Update Posted: 2025-08-19
• Study Start: 2025-11-01
• Primary Completion: 2026-03-31
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
IBS- SSS	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)