No Guts No Glory Probiotics

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

Conditions

• Patients Using Olanzapine, Quetiapine, Risperidone or Clozapine

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

Sponsors & Collaborators

• The Dutch Brain Foundation (funding)

  collaborator UNKNOWN

• Parnassia Groep

  collaborator OTHER

• KienVIP

  collaborator UNKNOWN

• University Medical Center Groningen

  lead OTHER

Principal Investigators

• Iris E.C. Sommer, Prof. Dr. · University Medical Center Groningen

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-01

Primary Completion

2029-05-01

Completion

2029-05-01

Countries

• Netherlands

Study Locations