No Guts No Glory Probiotics: Can probiotics help with antipsychotic side effects?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled trial evaluating Ecologic Barrier versus a placebo over 12 weeks in adults who are initiating or recently started on antipsychotic medicines such as olanzapine, quetiapine, risperidone, or clozapine. Participants will take two probiotic sachets daily, attend several clinic visits or home visits, and provide blood, stool, and dietary data to assess metabolic changes and safety. Primary outcomes focus on metabolic parameters like weight, glucose, and lipid levels, with secondary assessments including questionnaires and cognitive testing. The study aims to determine if modulating the gut microbiome with probiotics can mitigate antipsychotic-induced metabolic disturbances.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. About to start, or having started within the last 8 weeks, antipsychotic treatment with olanzapine, quetiapine\*, clozapine or risperidone for treating psychosis
2. Aged between 18 - 65
3. 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)
4. 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

Exclusion Criteria:

1. 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
2. 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
3. Pregnancy or breastfeeding
4. 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

Where it's running

• KieN VIP Leeuwarden
  Leeuwarden, Provincie Friesland, Netherlands Recruiting
• University Medical Center Groningen
  Groningen, Provincie Groningen, Netherlands Recruiting
• Antes Parnassia Groep
  Rotterdam, South Holland, Netherlands Recruiting

Study contacts

• Principal investigator: Iris E.C. Sommer, Prof. Dr. — University Medical Center Groningen
• Study coordinator: Toon A.W. Scheurink, MSc
• Email: a.w.scheurink@umcg.nl
• Phone: +31681528283

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.