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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Adults; GLP-1
• Intervention / Treatment: Dietary supplement: Multivitamin and a Probiotic

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Irfan Qureshi, MD; Phone Number: +1 800-843-9660; Email: trials@metagenics.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Active Comparator: PhytoMulti® Multivitamin and UltraFlora® Balance Probiotic arm

Dietary supplement: Multivitamin 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IBS- SSS	To assess impact of PhytoMulti® multivitamin and UltraFlora® Balance Probiotic on abdominal symptoms using the IBS severity scoring system (IBS-SSS)	From enrollment to the end of treatment at 12 weeks (90 days)

Collaborators and Investigators

• Sponsor: Metagenics, Inc.
• Investigators: Study Director: Mieke Van Den Driessche, PhD, Metagenics, Inc.; Principal Investigator: Irfan Qureshi, MD, Metagenics, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: August 12, 2025
• First Submitted That Met QC Criteria: August 12, 2025
• First Posted (Actual): August 19, 2025

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: GLO-NAM-2025-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No