NCT07606014RecruitingPhase 2/3
No Guts No Glory Probiotics
Probiotic Formulation to Prevent or Mitigate Antipsychotic Induced Metabolic Side-effects - A Multi-centre Randomized Placebo-controlled Double-blind Trial
Source: ClinicalTrials.gov · Last updated 26 May 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 112 (estimated)
- First submitted
- 18 May 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 1 May 2029
- Lead sponsor
- University Medical Center Groningen
- Diseases
- Schizophrenia
- NCT number
- NCT07606014
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 112
- From 1 Jun 2026 to the primary completion date, 1 May 2029
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Pregnancy or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
| KieN VIP Leeuwarden Coordinator of this site? Confirm its status | Leeuwarden | Netherlands | Recruiting |
| Antes Parnassia Groep Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.