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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how a probiotic called Bifidobacterium longum APC1472 may help reduce weight gain and metabolic problems caused by antipsychotic drugs in people with psychosis. Antipsychotic medications, while effective for psychiatric disorders like schizophrenia and bipolar disorder, often lead to significant weight gain and changes in metabolism that can harm physical health and decrease quality of life. This study explores if targeting gut bacteria can ease these side effects and improve medication adherence and overall wellbeing. Participants will be randomly assigned to take either the probiotic Bifidobacterium longum APC1472 capsules or placebo capsules containing maltodextrin. The study includes a treatment phase lasting 12 weeks, followed by a 6-week washout period. Both groups will take their assigned capsules regularly during the treatment phase to assess the probiotic's potential to lessen weight gain, blood sugar changes, and other metabolic effects related to antipsychotic use. During the study, participants will have their weight, glucose levels, waist-to-hip ratio, metabolic markers, cortisol levels, treatment adherence, and food intake behavior monitored at baseline and after 4, 8, 12, and 18 weeks. Blood, saliva, and stool samples will be collected to analyze biological changes. The study follows participants closely to track any improvements or side effects, aiming to support better health outcomes for those taking antipsychotic medications over a total of 18 weeks.
CONDITIONS
Brief Title
A Probiotic Strategy for Antipsychotic-induced Metabolic Dysfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 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 provide 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 anti-coagulants, anti-inflammatory drugs, NSAIDs, and analgesics within 4 weeks prior to study
- Presence of clinically significant or unstable medical conditions such as congestive heart failure, coeliac disease, or immunodeficiency syndrome
- Use of prebiotic or probiotic supplements within the past 30 days
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive either Bifidobacterium longum APC1472 capsules or placebo capsules to assess effects on weight gain and metabolic side-effects during antipsychotic treatment.
Visits at baseline, Week 4, Week 8, and Week 12
Duration - 6 weeks
Participants are monitored after stopping the supplementation to assess lasting effects and washout outcomes.
1 visit at Week 18
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
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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