NCT07606014 No Guts No Glory Probiotics
| NCT ID | NCT07606014 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | University Medical Center Groningen |
| Condition | Patients Using Olanzapine, Quetiapine, Risperidone or Clozapine |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2029-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 112 participants in total. It began in 2026-06-01 with a primary completion date of 2029-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
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
Contact & Investigator
Iris E.C. Sommer, Prof. Dr.
PRINCIPAL INVESTIGATOR
University Medical Center Groningen
Frequently Asked Questions
Who can join the NCT07606014 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Patients Using Olanzapine, Quetiapine, Risperidone or Clozapine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07606014 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07606014 currently recruiting?
Yes, NCT07606014 is actively recruiting participants. Contact the research team at a.w.scheurink@umcg.nl for enrollment information.
Where is the NCT07606014 trial being conducted?
This trial is being conducted at Leeuwarden, Netherlands, Groningen, Netherlands, Rotterdam, Netherlands.
Who is sponsoring the NCT07606014 clinical trial?
NCT07606014 is sponsored by University Medical Center Groningen. The principal investigator is Iris E.C. Sommer, Prof. Dr. at University Medical Center Groningen. The trial plans to enroll 112 participants.