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

N/ANot Yet RecruitingNCT07130396

Metagenics, Inc.100 enrolled

Overview

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

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

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

100

Conditions

GLP-1 Adults

Interventions

Multivitamin and a ProbioticDIETARY_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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Central Contacts

Irfan Qureshi, MD

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.