Menu
Not yet recruiting NCT07209046

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

No phase Interventional Adults GLP-1

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: UltraFlora® Triplebiotic, Placebo.
Who it may be relevant to
Registry conditions: Adults, GLP-1. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Double-blind, Double-arm Study Conducted Directly With Consumers Via an App "Baritastic App", Evaluating the Efficacy of a Supplement Containing Bifidobacterium Lactis B420 and Pasteurized Akkermansia Muciniphila (UltraFlora® Triplebiotic) for 3 Months in Adults After Discontinuation of GLP-1 Treatment.

Overview

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.

Interventions

  • Dietary supplement 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.
  • 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.

Primary outcome measures

  • weight measurement [Time frame: From enrollment to the end of treatment at 12 weeks (90 days)]
Secondary outcome measures (3)
  • IBS-SSS (Irritable Bowel Syndrome - Severity Scoring System) questionnaire [Time frame: From enrollment to the end of treatment at 12 weeks (90 days)]
  • SVS (Subjective Vitality Scale) questionnaire [Time frame: From enrollment to the end of treatment at 12 weeks (90 days)]
  • TFEQ-R18 (Three-Factor Eating Questionnaire - Revised 18 items) Questionnaire [Time frame: From enrollment to the end of treatment at 12 weeks (90 days)]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07209046 · GLO-NAM-2025-04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗