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

NCT ID: NCT07130396

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2026-04-30

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.

Conditions

GLP-1; Adults

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

PhytoMulti® Multivitamin and UltraFlora® Balance Probiotic arm

Group Type: ACTIVE_COMPARATOR

Multivitamin and a Probiotic

Intervention Type: DIETARY_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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Metagenics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mieke Van Den Driessche, PhD

Role: STUDY_DIRECTOR

Metagenics, Inc.

Irfan Qureshi, MD

Role: PRINCIPAL_INVESTIGATOR

Metagenics, Inc.

Central Contacts

Irfan Qureshi, MD

Role: CONTACT

trials@metagenics.com

+1 800-843-9660

Other Identifiers

GLO-NAM-2025-02

Identifier Type: -

Identifier Source: org_study_id