Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07130396

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. IBS- SSS

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

    To assess impact of PhytoMulti® multivitamin and UltraFlora® Balance Probiotic on abdominal symptoms using the IBS severity scoring system (IBS-SSS)

Study contacts

Contact information is provided by the study sponsor or research team.

Irfan Qureshi, MD

CONTACT

[email protected]

+1 800-843-9660

Sponsors and collaborators

Lead sponsor

Metagenics, Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.