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RECRUITING
NCT07606014
PHASE2/PHASE3

No Guts No Glory Probiotics

Sponsor: University Medical Center Groningen

View on ClinicalTrials.gov

Summary

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

Official title: Probiotic Formulation to Prevent or Mitigate Antipsychotic Induced Metabolic Side-effects - A Multi-centre Randomized Placebo-controlled Double-blind Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

112

Start Date

2026-06-01

Completion Date

2029-05-01

Last Updated

2026-05-26

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Probiotic Formula

After 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

DIETARY_SUPPLEMENT

Placebo

* 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

Locations (3)

KieN VIP Leeuwarden

Leeuwarden, Provincie Friesland, Netherlands

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Antes Parnassia Groep

Rotterdam, South Holland, Netherlands