An interventional study of UltraFlora® Triplebiotic and Placebo in Adults and GLP-1, sponsored by Metagenics, Inc.. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-06.
Sponsored by Metagenics, Inc. · Not applicable, Interventional, and Supportive care
This is a randomized, double-blind, double arm study involving 128 participants who will undergo a total participation period of 12 weeks.
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.
Metagenics, Inc. is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
Time frame: From enrollment to the end of treatment at 12 weeks (90 days)
IBS-SSS (Irritable Bowel Syndrome - Severity Scoring System) questionnaire
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.
Time frame: From enrollment to the end of treatment at 12 weeks (90 days)
SVS (Subjective Vitality Scale) questionnaire
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).
Time frame: From enrollment to the end of treatment at 12 weeks (90 days)
TFEQ-R18 (Three-Factor Eating Questionnaire - Revised 18 items) Questionnaire
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.
Time frame: From enrollment to the end of treatment at 12 weeks (90 days)
Assessment of appetite (e.g., number of meals) and food cravings (e.g., snacking or food preferences) in seven questions.
How hungry were you today? How full do you feel right now? How many meals ? Did you think about your next meal when you finished your meal? How many craving did you have today? How strong is your desire to eat? How much food do you think you could eat right now?
Time frame: 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)
Expressed any of the following symptoms: headache(s), rash(es), cough, changes in appetite, or other.
Time frame: The proportion of participants at day 14 (T1), day 30 (T2), day 60 (T3), day 90 (T4),
patient satisfaction with product use and recommendation
Evaluate the impact of UltraFlora Triplebiotic containing Bifidobacterium Lactis B420 and pasteurized Akkermansia Muciniphila after 90 days. Is satisfied with the intervention ? Would recommend the product ? Would purchase the product ?
Time frame: The proportion of participants that at day 90 (T4):
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2025; primary completion for Jun 2026, 7 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Metagenics, Inc.