Probiotic formulation for patients with schizophrenia or bipolar disorder who have screened positive for increased intestinal permeability<br>

Phase 4

Recruiting

Conditions: Schizophrenia
Schizophrenia en bipolar disorder
10026753

Registration Number: NL-OMON53363

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 145

Inclusion Criteria

1.Age 18-65 years;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;4.Serum LPS-binding protein (LBP) values of 9 ng/ml or higher

Exclusion Criteria

1.Pregnancy or breastfeeding;2.Mental retardation (IQ score <60);3.Active liver-, kidney- or pancreas disease as defined by ALAT > two times the upper boundary of normal levels;4.Any clinically significant or unstable medical disorder as determined by the investigators, including IBD, short-bowel syndrome or acute/chronic pancreatitis

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is psychiatric symptoms severity as assessed with the Brief<br /><br>Psychiatric Rating Scale (BPRS).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>secondary outcomes are cognition , functional disability as assessed with the<br /><br>World Health Organization*s Disability Schedule (WHO-DAS II), quality of life,<br /><br>recovery, and side-effects together with peripheral immune markers and markers<br /><br>of intestinal barrier function. Stool and blood samples are analysed to<br /><br>identify optimal biomarkers for response to probiotics.</p><br>