No Guts No Glory Probiotics
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity Medical Center Groningen
About this trial
The goal of this clinical trial is to learn if probiotics work to prevent or reduce metabolic side effects caused by antipsychotic medication in adults.
The main question it aims to answer is:
Do probiotics reduce weight gain, blood sugar levels, and blood fat levels in people using antipsychotics?
Researchers will compare a probiotic (Ecologic® Barrier) to a placebo (a look-alike powder without active bacteria) to see if the probiotic is effective.
Participants will:
Take either probiotics or a placebo daily for 12 weeks (3 months) Dissolve two sachets in water and drink them each morning Visit the clinic (or receive home visits) four times: at the start, after 6 weeks, and after 12 weeks, plus an initial screening visit Undergo physical measurements (e.g., weight, blood pressure), complete questionnaires, and perform a cognitive test at specific visits Provide blood samples and stool samples at the beginning and end of the study Complete two 3-day food diaries during the study
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
About to start, or having started within the last 8 weeks, antipsychotic treatment with olanzapine, quetiapine*, clozapine or risperidone for treating psychosis
Aged between 18 - 65
No exposure to these four antipsychotic medications for longer than one week continuously in the last 6 months (except starting the treatment with the current medication 8 weeks prior to the inclusion)
The participant understands the study and is able to provide written informed consent.
Disqualifiers
Critically ill patients (e.g. ICU), diagnosed comorbid eating disorders, chronic GI-disorders, disorders of the liver or pancreas, pre-existing diagnosed diabetes mellitus or metabolic syndrome
Current use of medications known to target metabolism or weight (e.g, diabetes medication and GLP-1 agonists, proton pump inhibitors and diuretics/beta blockers) or use of antibiotics or probiotics (such as Yakult, Activia, or other probiotic supplements containing ≥10⁹ CFUs) in the past 4 weeks
Pregnancy or breastfeeding
Inability to follow the intervention or other conditions that according to the investigator might interfere with the evaluation of the study objectives as judged by the treating physician
Trial design
Design model
Single group
Treatments tested in this trial
Probiotic Formula
Dietary supplementAfter informed consent, participants will be randomized 1:1 to either: * Intervention group: Ecologic® Barrier * Control group: Placebo powder (identical in appearance, taste, and packaging but without active bacterial strains) Ecologic® Barrier * Dosage form: Powder formulation containing a multi-strain probiotic mixture * Dosage: Standard manufacturer-recommended dose per sachet * Frequency: Twice daily (morning and evening) * Route of administration: Oral, dissolved in water or another non-carbonated beverage * Duration: 12 weeks (3 months) * Distinguishing characteristics: * Contains a defined combination of probiotic strains specifically formulated to support gut ba- rrier integrity * Delivered as a powder sachet to ensure stability of live bacterial cultures * Designed to modulate gut-brain axis pathways relevant to antipsychotic-associated metabolic effects
Placebo
Dietary supplement* Dosage form: Powder identical in appearance, texture, and packaging to the active product * Dosage: One sachet per administration * Frequency: Twice daily * Route of administration: Oral * Duration: 12 weeks * Distinguishing characteristics: * Contains no active probiotic strains * Formulated to match the organoleptic properties of Ecologic® Barrier to maintain blinding
Treatment groups
112 Participants
are divided into 2 treatment groupsGroup A: Probiotic interventionExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Hemoglobin A1C
Average blood glucose levels during the past 2 or 3 months
Time frame
From enrollment to the end of treatment at 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Medical Center Groningen
Lead sponsor
The Dutch Brain Foundation (funding)
Collaborator
Parnassia Groep
Collaborator
KienVIP
Collaborator
Source ClinicalTrials.gov