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

ConditionsGLP-1 Adults

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorMetagenics, Inc.

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: PhytoMulti® Multivitamin and UltraFlora® Balance Probiotic armActive comparator 1 intervention

Trial 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)

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Metagenics, Inc.

Lead sponsor

Source ClinicalTrials.gov

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