AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

No Guts No Glory Probiotics

RecruitingPhase 2, Phase 3Ages 18 Years - 65 YearsAllUniversity Medical Center Groningen
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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 (Ecologicยฎ 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 st

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ10โน 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
๐Ÿ’Š

What it tests

  • Probiotic Formula
  • Placebo
๐Ÿ“

Where

3 sites
KieN VIP Leeuwarden
Leeuwarden, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Antes Parnassia Groep
Rotterdam, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy