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No Guts No Glory Probiotics (NGNGP)

18. maj 2026 opdateret af: University Medical Center Groningen

Probiotic Formulation to Prevent or Mitigate Antipsychotic Induced Metabolic Side-effects - A Multi-centre Randomized Placebo-controlled Double-blind Trial

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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Antipsychotic medications such as olanzapine, quetiapine, clozapine, and risperidone are widely used for the treatment of psychotic and mood disorders. Although effective, these medications are frequently associated with adverse metabolic effects, including weight gain, increased blood glucose levels, and dyslipidemia. These side effects can negatively impact physical health and increase the risk of cardiovascular disease and diabetes.

Emerging evidence suggests that the gut microbiome may play a role in metabolic regulation and that modulation of gut microbiota through probiotics could mitigate antipsychotic-induced metabolic disturbances. Probiotics are live microorganisms that, when administered in adequate amounts, may confer health benefits by improving gut barrier function and influencing metabolic processes.

This study is a randomized, double-blind, placebo-controlled clinical trial designed to investigate the efficacy and safety of a multispecies probiotic formulation (Ecologic® Barrier) in preventing or reducing metabolic side effects in patients initiating treatment with antipsychotic medication. A total of 112 participants will be enrolled and randomly assigned to receive either the probiotic or a placebo for a duration of 12 weeks.

The investigational product consists of a powder formulation containing nine bacterial strains, administered as two sachets dissolved in water once daily in the morning. The placebo consists of an inert powder (e.g., maize starch and maltodextrin) with identical appearance and administration schedule. Participants, investigators, and study personnel will remain blinded to treatment allocation throughout the study.

Participants will continue their standard psychiatric treatment, including antipsychotic and/or mood-stabilizing medication, with minimal changes where possible. Concomitant use of additional psychotropic medications such as a second antipsychotic, lithium, or antiepileptic drugs is permitted.

Study procedures include baseline, interim (6 weeks), and end-of-study (12 weeks) assessments. These assessments involve physical measurements (e.g., body weight, waist and hip circumference, blood pressure), laboratory analyses of metabolic parameters using blood samples, and stool sample collection for microbiome-related analyses. In addition, participants will complete validated questionnaires assessing quality of life, eating behavior, and gastrointestinal symptoms, as well as cognitive testing at baseline and study completion.

Dietary intake will be monitored using two 3-day food diaries (pre-intervention and prior to the final visit) to account for potential dietary influences on metabolic outcomes and gut microbiota.

The primary objective is to evaluate whether probiotic supplementation reduces antipsychotic-induced metabolic disturbances compared to placebo. Secondary objectives include assessing safety and tolerability, as well as exploring changes in gastrointestinal symptoms, cognitive functioning, and potential microbiome-related mechanisms.

The total study duration per participant is approximately 3 months, with an additional optional one-month post-study probiotic use. After study completion, treatment allocation will be unblinded. Participants will be monitored throughout the study for adverse events, with particular attention to gastrointestinal symptoms, which are expected to be mild and transient.

This study aims to provide further evidence on the role of probiotics as a low-risk, adjunctive intervention to improve metabolic health in patients treated with antipsychotic medication.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

112

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Holland
    • Provincie Friesland
      • Leeuwarden, Provincie Friesland, Holland, 8911KJ
        • Rekruttering
        • KieN VIP Leeuwarden
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Nynke Boonstra, PhD
    • Provincie Groningen
      • Groningen, Provincie Groningen, Holland, 9713GZ
        • Rekruttering
        • University Medical Center Groningen
        • Kontakt:
        • Ledende efterforsker:
          • Iris E.C. Sommer, MD, PhD
    • South Holland
      • Rotterdam, South Holland, Holland, 3083AK
        • Rekruttering
        • Antes Parnassia Groep
        • Kontakt:
        • Ledende efterforsker:
          • Nico van Beveren, MD, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Probiotic intervention
This group uses a probiotic formulation to prevent metabolic risk factors of antipsychotics
Kosttilskud: Probiotic Formula

After informed consent, participants will be randomized 1:1 to either:

  • Intervention group: Ecologic® Barrier
  • Control group: Placebo powder (identical in appearance, taste, and packaging but without active bacterial strains)

Ecologic® Barrier

  • Dosage form: Powder formulation containing a multi-strain probiotic mixture
  • Dosage: Standard manufacturer-recommended dose per sachet
  • Frequency: Twice daily (morning and evening)
  • Route of administration: Oral, dissolved in water or another non-carbonated beverage
  • Duration: 12 weeks (3 months)
  • Distinguishing characteristics:
  • Contains a defined combination of probiotic strains specifically formulated to support gut ba- rrier integrity
  • Delivered as a powder sachet to ensure stability of live bacterial cultures
  • Designed to modulate gut-brain axis pathways relevant to antipsychotic-associated metabolic effects
Andre navne:
  • Ecologic Barrier
Placebo komparator: Placebo
This group uses a placebo
Kosttilskud: Placebo
  • Dosage form: Powder identical in appearance, texture, and packaging to the active product
  • Dosage: One sachet per administration
  • Frequency: Twice daily
  • Route of administration: Oral
  • Duration: 12 weeks
  • Distinguishing characteristics:
  • Contains no active probiotic strains
  • Formulated to match the organoleptic properties of Ecologic® Barrier to maintain blinding
Andre navne:
  • Placebo formulering

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hemoglobin A1C
Tidsramme: From enrollment to the end of treatment at 12 weeks
Average blood glucose levels during the past 2 or 3 months
From enrollment to the end of treatment at 12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Medical Center Groningen

Samarbejdspartnere

Parnassia Groep
The Dutch Brain Foundation (funding)
KienVIP

Efterforskere

  • Ledende efterforsker: Iris E.C. Sommer, Prof. Dr., University Medical Center Groningen

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. maj 2029

Studieafslutning (Anslået)

1. maj 2029

Datoer for studieregistrering

Først indsendt

18. maj 2026

Først indsendt, der opfyldte QC-kriterier

18. maj 2026

Først opslået (Faktiske)

26. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NL88832.042.25

Plan for individuelle deltagerdata (IPD)

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