No Guts No Glory Probiotics

NCT07606014 | Recruiting Phase 2

• 1 other identifier: NL88832.042.25
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Antipsychotics; Probiotics; Psychosis; Schizophrenia; Metabolic syndrome; HbA1c; Blood glucose; Weight gain; Olanzapine; Quetiapine; Risperidone; Clozapine

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1C

  Average blood glucose levels during the past 2 or 3 months

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Probiotic intervention

EXPERIMENTAL

This group uses a probiotic formulation to prevent metabolic risk factors of antipsychotics

Dietary Supplement: Probiotic Formula

Placebo

PLACEBO COMPARATOR

This group uses a placebo

Dietary Supplement: Placebo

Interventions

Probiotic Formula DIETARY_SUPPLEMENT

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

Also known as: Ecologic Barrier

Probiotic intervention

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

Also known as: Placebo formulation

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• The participant understands the study and is able to provide written informed consent.
• Quetiapine prescribed in a low dose for use as a sleep aid does not apply

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead
• The Dutch Brain Foundation (funding): collaborator
• Parnassia Groep: collaborator
• KienVIP: collaborator

Study Sites (3)

KieN VIP Leeuwarden

Leeuwarden, Provincie Friesland, 8911KJ, Netherlands

RECRUITING

University Medical Center Groningen

Groningen, Provincie Groningen, 9713GZ, Netherlands

RECRUITING

Antes Parnassia Groep

Rotterdam, South Holland, 3083AK, Netherlands

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia; Metabolic Syndrome; Weight Gain

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Iris E.C. Sommer, Prof. Dr.

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Toon A.W. Scheurink, MSc

CONTACT

+31681528283; a.w.scheurink@umcg.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 26, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: May 26, 2026

Record last verified: 2026-05

Locations

NL (3)