Probiotic formulation for patients with psychotic or bipolar disorder who have screened positive for increased intestinal permeability
Recruiting
- Conditions
- schizophrenia disorder (295.x)schizo-affective disorder(295.x)schizophreniform disorder (295.x)bipolar disorder (296.x)
- Registration Number
- NL-OMON24444
- Lead Sponsor
- Prof. Dr. I.E.C. Sommer Universitair Medisch Centrum GroningenDepartment of Neuroscience i.e.c.sommer@umcg.nl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 145
Inclusion Criteria
1.Age = 18
2.The participant understands the study and is capable of providing written informed consent
3.The participant has a DSM-IV-R or DSM-5 diagnosis of: 295.x (schizophrenia, schizophreniform disorder or schizo-affective disorder) or bipolar disorder 296.x
Exclusion Criteria
1.Pregnancy or breastfeeding (assessed through anamnesis)
2.Mental retardation (IQ score <60)
3.Active liver-, kidney- or pancreas disease as defined by alanine amino transferase (ALAT) levels more than two times the upper boundary of normal levels
4.Any clinically significant or unstable medical disorder as determined by the investigators, including inflammatory bowel disease, short-bowel syndrome or acute/chronic pancreatitis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome measurements are psychiatric symptoms severity as assessed with the Brief Psychiatric Rating Scale (BPRS) and cognition as assessed with the Brief Assessment of<br>Cognition in Schizophrenia (BACS) and the Stroop task
- Secondary Outcome Measures
Name Time Method Secondary outcomes are immune parameters, metabolic syndrome features, side-effects, general functioning (World Health Organization’s Disability Schedule (WHO-DAS II)) and gastro-intestinal complaints. Stool and blood samples are analysed to identify optimal biomarkers (serum LBP, fecal calprotectin, intestinal microbiome) for response to probiotics.