GOSAT: The role of Galacto-oligosaccharides (GOS) in the recovery from dysbiosis in patients on long-term atypical antipsychotic treatment
Recruiting
- Conditions
- upset bowels10039628dysbiosis
- Registration Number
- NL-OMON53429
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
• age between 18 - 75 years • who receive atypical antipsychotic medication
(>=0.5 defined daily dose [DDD], olanzapine, risperidone, clozapine, quetiapine,
and aripiprazol) within the preceding eight weeks • who are overweight or obese
(BMI >25 kg/m2)
Exclusion Criteria
• pregnancy
• breastfeeding
• expected discharge or transfer within 10 weeks
• contra-indication for prebiotics
• continuous use of pre-, pro-, or synbiotics (within the preceding 4 weeks)
• recent (8 week) use or continuous use of antibiotics
• cow's milk allergy/lactose intolerance
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the change in Bifidobacteria in fecal samples from week<br /><br>0 to week 6.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objective is to assess the effects of GOS on mental wellbeing<br /><br>(i.e., Depression Anxiety Stress Scale (DASS-21), self-rated health (SRH),<br /><br>Quality of life (EQ-5D), Social Dysfunction and Aggression Scale (SDAS),<br /><br>happiness, Patient Health Questionnaire (PHQ), and Clinical Global Impression<br /><br>(CGI)), and sleep (i.e., Insomnia Rating Scale (IRS)), and metabolic parameters<br /><br>(i.e., waist circumference (WC), systolic and diastolic blood pressure, body<br /><br>mass index (BMI), and waist-to-hip ratio (WHR)). We hypothesize that GOS+2*FL<br /><br>supplementation will improve gut health, and mental wellbeing, sleep, and<br /><br>metabolic parameters. Other outcomes that are assessed include the FiberScreen<br /><br>tool, the form of human faeces (Bristol Stool Chart), side effects and the<br /><br>defined daily dosis (DDD) of antipsychotic medication.</p><br>