Impact of Probiotic (UltraFlora® Triplebiotic) on Weight Evolution on People After Discontinuation of GLP-1 Treatment.

NCT ID: NCT07209046

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2026-07-31

Brief Summary

This is a randomized, double-blind, double arm study involving 128 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 UltraFlora® Triplebiotic at a fixed dose of 2 capsule per day, administered orally once daily with food. During the 12-week treatment period, participants will be asked to complete questions and track their weight changes.

Conditions

Adults; GLP-1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

UltraFlora® Triplebiotic

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 (UltraFlora® Triplebiotic, 2 capsules/day) are taken daily with breakfast.

Group Type: ACTIVE_COMPARATOR

UltraFlora® Triplebiotic

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 probiotic ( UltraFlora® Triplebiotics, 2 capsules/day) are taken daily with a glass of water.

Orally administration of 2 capsules/day of placebo

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 placebo (2 capsules/day) are taken daily with breakfast.

Group Type: PLACEBO_COMPARATOR

Placebo

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 placebo (2 capsule/day) are taken daily with a glass of water.

Interventions

UltraFlora® Triplebiotic

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 probiotic ( UltraFlora® Triplebiotics, 2 capsules/day) are taken daily with a glass of water.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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 placebo (2 capsule/day) are taken daily with a glass of water.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Providing written informed consent

2. Males and females of at least 18 years old

3. Body mass index (BMI) between 25 and 30 (including 25 and 30) (Weight: 25 < BMI < 30)

4. Having undergone treatment with GLP-1 for more than 3 months but for less than 1 year.

5. Having stopped GLP-1 treatment for a maximum of 4 weeks

6. Being willing to maintain stable dietary habits and physical activity levels throughout the trial period

7. 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. Being on GLP-1 treatment

2. Having had any type of bariatric surgery, or planned bariatric surgery during the period of trial participation.

3. 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.

4. Suffering from any uncontrolled endocrine disorder.

5. Having consumed any probiotic supplements in the 3 months prior to enrollment.

6. Having used any antibiotic treatment in the 3 months prior to enrollment.

7. Having a known allergy to the ingredients in the study product.

8. Being pregnant or lactating (breastfeeding) or trying to become pregnant.

9. Participating in an other clinical trial.

10. Suffering from dementia or inability to take the trial treatment in an appropriate way.

11. Taking UltraFlora® Triplebiotic 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

800-843-9660

Other Identifiers

GLO-NAM-2025-04

Identifier Type: -

Identifier Source: org_study_id