Actively Recruiting
A Probiotic Strategy for Antipsychotic-induced Metabolic Dysfunction
Led by University College Cork · Updated on 2024-12-11
70
Participants Needed
2
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 antipsychotic medications. The investigators have previously published promising data demonstrating anti-obesity effects of a novel Bifidobacterium longum APC1472, in a mouse model of obesity and in an overweight/obese population of humans, reducing levels of glucose and normalizing ghrelin levels. Because atypical antipsychotic medications are often used in people experiencing psychosis and the mechanisms of antipsychotic-induced weight gain and metabolic dysfunction have been suggested to include glucose intolerance (hyperglycaemia) and aberrant ghrelin signalling, the investigators propose to assess if adjunct supplementation of Bifidobacterium longum APC1472 can attenuate weight gain and metabolic side-effects associated with the use of atypical antipsychotic medication in people with non- affective psychosis. The investigators propose an exploratory patient-oriented research study, to assess the potential of adjunct Bifidobacterium longum APC1472 supplementation in individuals with psychosis receiving antipsychotic treatment, to ameliorate the liability to gain weight and/or normalize metabolic disturbances. Findings from this study will support clinical decision-making, increasing patient choice, and increase medication adherence, which will ultimately improve health and quality of life, and overall wellbeing of individuals as they pass through normal life stages.
CONDITIONS
Official Title
A Probiotic Strategy for Antipsychotic-induced Metabolic Dysfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18-65 years old including women of child-bearing age
- Diagnosis of affective or non-affective functional psychosis according to ICD-10 criteria (codes F20-30 & F32.3)
- Able to and have given written informed consent
- Willing to provide blood samples
- Willing to provide saliva (cortisol) and fecal microbiome samples
- Use of psychotropic medications including antidepressants, mood stabilizers, hypnotics, and benzodiazepines is allowed
You will not qualify if you...
- Intravenous drug use
- Diagnosis of substance dependence in the past 3 months
- Pregnancy or planning a pregnancy
- Antibiotic use in the past 30 days
- Steroid use in the past 30 days
- Use of anticoagulants, anti-inflammatory drugs, NSAIDs, and analgesics without a 4-week washout period
- Clinically significant or unstable medical conditions including congestive heart failure, celiac disease, or immunodeficiency syndrome
- Use of pre- or probiotic supplements within the past 30 days
AI-Screening
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Trial Site Locations
Total: 2 locations
1
EIST clinics at St Mary's Primary Care Centre, Gurraunabraher & St Michaels In-Patient unit in the Mercy.
Cork, Ireland
Actively Recruiting
2
RISE Metabolic Monitoring Clinics
Cork, Ireland
Actively Recruiting
Research Team
H
Harriet Schellekens, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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