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A Probiotic Strategy for Antipsychotic-induced Metabolic Dysfunction

RecruitingNAAges 18 Years - 65 YearsAllUniversity College Cork
NCT06729671 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Antipsychotic drugs are used to treat a range of psychiatric disorders including schizophrenia, bipolar disorders, and psychotic depression. Most antipsychotics are associated with significant weight gain and metabolic disturbances, which increase the risks for other diseases (obesity, diabetes, coronary diseases, etc.) and negatively impact medication adherence and quality of life. Evidence has shown that Olanzapine, for example, increases appetite, food intake, and food reward and modulates the gut microbiota. The gut microbiota can modulate adiposity, metabolism and immune-endocrine signals that impact host's energy balance and feeding behaviour. This, together with the fact that antipsychotic-induced remodelling of the gut microbiota has been associated with weight gain, suggests that microbiota-targeted interventions could help to alleviate or prevent the distressing side-effects of

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📋 Eligibility rules (as published)
Inclusion Criteria: * 8.1 Inclusion Criteria To be considered eligible for enrolment into the study, subjects must; 1. Aged between 18-65 years old including women of child-bearing age 2. Having a diagnosis of affective or non-affective functional psychosis defined according to ICD-10 criteria for psychosis (codes F20-30 \& F32.3) 3. Patients who are able to and have given written informed consent 4. Patients who are willing to provide blood samples 5. Patients who are willing to provide saliva (cortisol) and faecal microbiome samples 6. Considering the nature of the study participants, a broad spectrum of concomitant medication will be permissible. Psychotropic meds, including antidepressants, mood stabilisers (lithium, valproate, carbamazepine), hypnotics and benzodiazapines, will be allowed as to not limit recruitment of this type of study participant. Exclusion Criteria: 1. Intravenous drug use 2. Diagnosis of substance dependence in the past 3 months 3. Pregnancy or planning a pregnancy 4. Antibiotic use in the past 30 days 5. Steroid use in the past 30 days 6. Use of anti-coagulants, anti-inflammatory drugs, over-the counter non-steroidal anti-inflammatories (NSAIDS) and analgesics. Subjects should have a wash-out period of 4 weeks. 7. Patients suffering from any clinically significant or unstable medical condition, including congestive heart failure, coeliac disease, or an immunodeficiency syndrome. 8. Pre or probiotic supplements within the past 30 days.
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What it tests

  • Bifidobacterium longum APC1472 hydroxypropylmethylcellulose (HPMC) capsule
  • maltodextrin
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Where

2 sites
EIST clinics at St Mary's Primary Care Centre, Gurraunabraher & St Michaels In-Patient unit in the Mercy.
Cork, Ireland
RISE Metabolic Monitoring Clinics
Cork, Ireland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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