Under construction – not a live service
Sign in
Taking people in NetherlandsPhase 2/3

Probiotics to Reduce Weight and Blood Sugar Problems From Antipsychotic Medicines

Tests a probiotic against placebo in adults taking antipsychotic medicines.

Key facts

Who runs it
University Medical Center Groningen
Where
Groningen, Leeuwarden, and Rotterdam, NetherlandsSee the 3 sites
Trial code
Registry title
No Guts No Glory Probiotics
Status
Recruiting
Phase
Phase 2/3
People taking part
112 people, planned
Started
1 Jun 2026
Expected to end
1 May 2029
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Probiotic Formula
  • Placebo
Record updated
26 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who are starting, or just started, an antipsychotic (olanzapine, quetiapine, clozapine or risperidone) for psychosis. It tests whether a probiotic reduces weight gain and blood sugar and fat changes.

Age
18 to 65 years
Sex
All sexes can join.
Disease stage
Psychosis treated with olanzapine, quetiapine, clozapine or risperidone, about to start or started within the last 8 weeks.
Earlier treatment
No more than one week of continuous use of these four antipsychotics in the last 6 months, except the current medicine started within the last 8 weeks. No antibiotics or probiotics in the past 4 weeks.

Main reasons for not taking part

  • Critically ill, or an eating disorder, long-term gut disease, liver or pancreas disease, diabetes or metabolic syndrome
  • Taking medicines for metabolism or weight, such as diabetes medicines or GLP-1 agonists
  • Antibiotics or strong probiotics in the past 4 weeks
  • Pregnant or breastfeeding
  • Low-dose quetiapine used only as a sleep aid

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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?

Where in Netherlands

  • University Medical Center GroningenGroningen, NetherlandsContact: Toon A.W. Scheurink, MScTaking people
  • KieN VIP LeeuwardenLeeuwarden, NetherlandsContact: Marrit WiersmaTaking people
  • Antes Parnassia GroepRotterdam, NetherlandsContact: Yunus A.W. Yalcin, PhDTaking people

About the trial

What the trial wants to find out

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

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

The 2 groups in the trial

  • Probiotic interventionTreatment being tested

    This group uses a probiotic formulation to prevent metabolic risk factors of antipsychotics

    Treatment: Probiotic Formula

  • PlaceboPlacebo, for comparison

    This group uses a placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Probiotic Formulation to Prevent or Mitigate Antipsychotic Induced Metabolic Side-effects - A Multi-centre Randomized Placebo-controlled Double-blind Trial
Plain-language title
Probiotics to Reduce Weight and Blood Sugar Problems From Antipsychotic MedicinesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Fit questions
Built from NCT07606014, who can take part
Record updated
26 May 2026