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New treatment option for Patients Using Olanzapine, Quetiapine, Risperidone or Clozapine
Official title No Guts No Glory Probiotics
ClinicalTrials.gov ID: NCT07606014
What this study is testing
- What it's testing
- 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?
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- About to start, or having started within the last 8 weeks, antipsychotic treatment with olanzapine, quetiapine\ , clozapine or risperidone for...
- 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 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 likely can't join if
- Critically ill patients (e.g. ICU), diagnosed comorbid eating disorders, chronic GI-disorders, disorders of the liver or pancreas, pre-existing...
- Current use of medications known to target metabolism or weight (e.g, diabetes medication and GLP-1 agonists, proton pump inhibitors and...
- Pregnancy or breastfeeding
- Inability to follow the intervention or other conditions that according to the investigator might interfere with the evaluation of the study...
The study team makes the final eligibility decision.
Where it's taking place
- Leeuwarden, Provincie Friesland, Netherlands
- Groningen, Provincie Groningen, Netherlands
- Rotterdam, South Holland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leeuwarden, Provincie Friesland, Netherlands; Groningen, Provincie Groningen, Netherlands; Rotterdam, South Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.