Using probiotics to address weight gain from antipsychotic medications

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the use of a specific probiotic, Bifidobacterium longum APC1472, to mitigate weight gain and metabolic dysfunction caused by antipsychotic medications in individuals diagnosed with psychosis. Participants aged 18-65 will be enrolled and will provide blood, saliva, and fecal samples to assess the impact of the probiotic on their metabolic health. The study aims to explore how modifying gut microbiota can alleviate the side effects of antipsychotic treatment, potentially improving adherence to medication and overall quality of life. The research is conducted at multiple locations in Cork, Ireland.

Why it matters

Who can join: the full rules

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.

Where it's running

• EIST clinics at St Mary's Primary Care Centre, Gurraunabraher & St Michaels In-Patient unit in the Mercy.
  Cork, Ireland Recruiting
• RISE Metabolic Monitoring Clinics
  Cork, Ireland Recruiting

Study contacts

• Principal investigator: Harriet Schellekens, PhD — University College Cork
• Study coordinator: Harriet Schellekens, PhD
• Email: H.schellekens@ucc.ie
• Phone: + 353 (0) 21 420 5429

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.