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

NCT07130396 | Not Yet Recruiting

• 1 other identifier: GLO-NAM-2025-02
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-arm, open-label clinical trial involving 100 participants who will undergo a total participation period of 12 weeks.

Conditions

GLP-1; Adults

Outcome Measures

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)

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

Study Arms (1)

PhytoMulti® Multivitamin and UltraFlora® Balance Probiotic arm

ACTIVE COMPARATOR

Dietary Supplement: Multivitamin and a Probiotic

Interventions

Multivitamin and a Probiotic 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

PhytoMulti® Multivitamin and UltraFlora® Balance Probiotic arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Metagenics, Inc.: lead

MeSH Terms

Interventions

Geritol

Study Officials

• Mieke Van Den Driessche, PhD

  Metagenics, Inc.

  STUDY DIRECTOR

• Irfan Qureshi, MD

  Metagenics, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irfan Qureshi, MD

CONTACT

+1 800-843-9660; trials@metagenics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 19, 2025
• Study Start: November 1, 2025
• Primary Completion: March 31, 2026
• Study Completion: April 30, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share