Using probiotics to address weight gain from antipsychotic medications

A Probiotic Strategy for Antipsychotic-induced Metabolic Dysfunction

This study is testing whether a specific probiotic can help people with psychosis who are gaining weight from their antipsychotic medications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University College Cork (Academic / other)
• Locations: 2 sites (Cork and 1 other locations)
• Trial ID: NCT06729671 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of functional psychosis who are currently on antipsychotic medication.

Not a fit: Patients with a history of intravenous drug use or substance dependence in the past three months may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce weight gain and metabolic issues in patients taking antipsychotic medications, enhancing their overall health and medication adherence.

How similar studies have performed: Previous studies have shown promising results with probiotics in managing weight gain in animal models, suggesting potential for success in human applications.

Eligibility criteria

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 this trial is running

Cork and 1 other locations

• 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

Conditions Psychosis; microbiota; antipsychotic; weight gain