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

NCT07209046 | Not Yet Recruiting

• 1 other identifier: GLO-NAM-2025-04
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a randomized, double-blind, double arm study involving 128 participants who will undergo a total participation period of 12 weeks.

Conditions

Adults; GLP-1

Outcome Measures

Primary Outcomes (1)

• weight measurement

  Evaluate the impact of UltraFlora Triplebiotic (containing Bifidobacterium Lactis B420 and pasteurized Akkermansia Muciniphila) on weight regain over 3 months after discontinuation of GLP-1.

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

Secondary Outcomes (3)

• IBS-SSS (Irritable Bowel Syndrome - Severity Scoring System) questionnaire

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

• SVS (Subjective Vitality Scale) questionnaire

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

• TFEQ-R18 (Three-Factor Eating Questionnaire - Revised 18 items) Questionnaire

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

Other Outcomes (3)

• Assessment of appetite (e.g., number of meals) and food cravings (e.g., snacking or food preferences) in seven questions.

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

• Side effects experienced when taking the test product or placebo throughout the study (product tolerance)

  The proportion of participants at day 14 (T1), day 30 (T2), day 60 (T3), day 90 (T4),

• patient satisfaction with product use and recommendation

  The proportion of participants that at day 90 (T4):

Study Arms (2)

UltraFlora® Triplebiotic

ACTIVE COMPARATOR

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.

Dietary Supplement: UltraFlora® Triplebiotic

Orally administration of 2 capsules/day of placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

UltraFlora® Triplebiotic 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.

UltraFlora® Triplebiotic

Placebo 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.

Orally administration of 2 capsules/day of placebo

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
• Body mass index (BMI) between 25 and 30 (including 25 and 30) (Weight: 25 \< BMI \< 30)
• Having undergone treatment with GLP-1 for more than 3 months but for less than 1 year.
• Having stopped GLP-1 treatment for a maximum of 4 weeks
• 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:

• Being on GLP-1 treatment
• 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 consumed any probiotic supplements in the 3 months prior to enrollment.
• Having used any antibiotic treatment in the 3 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 an other clinical trial.
• Suffering from dementia or inability to take the trial treatment in an appropriate way.
• Taking UltraFlora® Triplebiotic or any similar product from competitors prior to trial participation

Sponsors & Collaborators

• Metagenics, Inc.: lead

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

800-843-9660; trials@metagenics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: October 6, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share