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

Not Applicable

Not yet recruiting

• Conditions: Adults; GLP-1

• Registration Number: NCT07209046
• Lead Sponsor: Metagenics, Inc.

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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-18
• Study First Submitted QC: 2025-09-29
• Last Update Submitted: 2025-09-29
• Study First Posted: 2025-10-06
• Last Update Posted: 2025-10-06
• Study Start: 2025-11-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
weight measurement	From enrollment to the end of treatment at 12 weeks (90 days)	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.

Secondary Outcome Measures

Name	Time	Method
IBS-SSS (Irritable Bowel Syndrome - Severity Scoring System) questionnaire	From enrollment to the end of treatment at 12 weeks (90 days)	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. It is a visual analog scale ranging from 0 to 100 that allows the severity of patients' gastrointestinal symptoms to be assessed. The higher the score, the more pain the patient is experiencing.
SVS (Subjective Vitality Scale) questionnaire	From enrollment to the end of treatment at 12 weeks (90 days)	Evaluate the impact of UltraFlora Triplebiotic containing Bifidobacterium Lactis B420 and pasteurized Akkermansia Muciniphila on vitality using the Subjective Vitality Scales (SVS) questionnaire. This questionnaire assesses a state of well-being and optimal functioning in relation to independence and physical and psychological health. Scores range from 1 (very low vitality) to 7 (optimal vitality).
TFEQ-R18 (Three-Factor Eating Questionnaire - Revised 18 items) Questionnaire	From enrollment to the end of treatment at 12 weeks (90 days)	Evaluate the impact of UltraFlora Triplebiotic containing Bifidobacterium Lactis B420 and pasteurized Akkermansia Muciniphila on Hunger, Appetite and Cravings using the TFEQ-R18 Questionnaire over the course of 90 days. The TFEQ-R18 is a psychometric questionnaire that assesses eating behaviors and attitudes toward food. There are three dimensions: CR = conscious restraint, UE = uncontrolled eating, EE = emotional eating. High scores in UE or EE indicate an increased risk of overeating, weight gain, or eating disorders. A high score in CR shows a strong desire to restrict intake, but this is sometimes associated with episodes of disinhibition if the restriction fails.