Probiotic formulation for patients with psychotic or bipolar disorder who have screened positive for increased intestinal permeability

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24444

Enrollment

145

Registered

2018-12-13

Start date

2019-05-15

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

schizophrenia disorder (295.x) schizo-affective disorder(295.x) schizophreniform disorder (295.x) bipolar disorder (296.x)

Interventions

Patients screened positive for LBP and other inclusion criteria will enter a 12 week treatment period in which they are randomized 1:1 to either twice daily 2 gram probiotic formulation (Ecologic®Barr

Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lac

1x1010 colony forming units/day) or placebo twice daily. Outcome measurements will be assessed at baseline, half way treatment, end of treatment, and at a follow-up 3 months post-treatment.

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 Cognition in Schizophrenia (BACS) and the Stroop task	—

Secondary

Measure	Time frame
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.	—

Contacts

Public ContactIris Sommer

UMCG

i.e.c.sommer@umcg.nl+31 (0)62564748

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)