A Probiotic Strategy for Antipsychotic-induced Metabolic Dysfunction

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 8.1 Inclusion Criteria To be considered eligible for enrolment into the study, subjects must;

‣ Aged between 18-65 years old including women of child-bearing age

⁃ Having a diagnosis of affective or non-affective functional psychosis defined according to ICD-10 criteria for psychosis (codes F20-30 \& F32.3)

⁃ Patients who are able to and have given written informed consent

⁃ Patients who are willing to provide blood samples

⁃ Patients who are willing to provide saliva (cortisol) and faecal microbiome samples

⁃ 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.

Locations
Other Locations
Ireland
EIST clinics at St Mary's Primary Care Centre, Gurraunabraher & St Michaels In-Patient unit in the Mercy.
RECRUITING
Cork
RISE Metabolic Monitoring Clinics
RECRUITING
Cork
Contact Information
Primary
Harriet Schellekens, PhD
H.schellekens@ucc.ie
+ 353 (0) 21 420 5429
Time Frame
Start Date: 2024-05-16
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 70
Treatments
Placebo_comparator: placebo
hydroxypropylmethylcellulose (HPMC) capsule with maltidextrin
Active_comparator: active
Bifidobacterium longum APC1472 hydroxypropylmethylcellulose (HPMC) capsules
Sponsors
Leads: University College Cork

This content was sourced from clinicaltrials.gov

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