Probiotics to Reduce Weight and Blood Sugar Problems From Antipsychotic Medicines
Tests a probiotic against placebo in adults taking antipsychotic medicines.
Plain-language title generated from the registry record
Registry title: No Guts No Glory Probiotics
Key facts
- Where
- Groningen, Leeuwarden, and Rotterdam, NetherlandsSee the 3 sites
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07606014, who can take part
Where in Netherlands
- University Medical Center GroningenGroningen, NetherlandsTaking people
- KieN VIP LeeuwardenLeeuwarden, NetherlandsTaking people
- Antes Parnassia GroepRotterdam, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Medical Center Groningen
- Trial code
- NCT07606014
- Record updated
- 26 May 2026
- Original description
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.Read full original descriptionShow less
Probiotic Formulation to Prevent or Mitigate Antipsychotic Induced Metabolic Side-effects - A Multi-centre Randomized Placebo-controlled Double-blind 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
Inclusion: 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; Quetiapine prescribed in a low dose for use as a sleep aid does not apply.
Exclusion: 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; 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; Pregnancy or breastfeeding.