GOSAT: The role of Galacto-oligosaccharides (GOS) in the recovery from dysbiosis in patients on long-term atypical antipsychotic treatment

GOSAT: The role of Galacto-oligosaccharides (GOS) in the recovery from dysbiosis in patients on long-term atypical antipsychotic treatment - Prebiotics among users of atypical antipsychotics

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53429

Enrollment

Registered

2023-08-29

Start date

2023-11-29

Completion date

Unknown

Last updated

2026-07-20

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

Conditions

dysbiosis

Interventions

Following a run-in period of 4 weeks (no intervention but all other aspects of&nbsp

the study), the participants will consume GOSplus (7.0 g BiotisTMGOS + 0.7 g 2*- FL) daily during the first consumption moment of the day (preferably in the&nbsp

morning) for 42 days.

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the change in Bifidobacteria in fecal samples from week 0 to week 6.	—

Secondary

Measure	Time frame
The secondary objective is to assess the effects of GOS on mental wellbeing (i.e., Depression Anxiety Stress Scale (DASS-21), self-rated health (SRH), Quality of life (EQ-5D), Social Dysfunction and Aggression Scale (SDAS), happiness, Patient Health Questionnaire (PHQ), and Clinical Global Impression (CGI)), and sleep (i.e., Insomnia Rating Scale (IRS)), and metabolic parameters (i.e., waist circumference (WC), systolic and diastolic blood pressure, body mass index (BMI), and waist-to-hip ratio (WHR)). We hypothesize that GOS+2*FL supplementation will improve gut health, and mental wellbeing, sleep, and metabolic parameters. Other outcomes that are assessed include the FiberScreen tool, the form of human faeces (Bristol Stool Chart), side effects and the defined daily dosis (DDD) of antipsychotic medication.	—

Measure

Time frame

The secondary objective is to assess the effects of GOS on mental wellbeing (i.e., Depression Anxiety Stress Scale (DASS-21), self-rated health (SRH), Quality of life (EQ-5D), Social Dysfunction and Aggression Scale (SDAS), happiness, Patient Health Questionnaire (PHQ), and Clinical Global Impression (CGI)), and sleep (i.e., Insomnia Rating Scale (IRS)), and metabolic parameters (i.e., waist circumference (WC), systolic and diastolic blood pressure, body mass index (BMI), and waist-to-hip ratio (WHR)). We hypothesize that GOS+2*FL supplementation will improve gut health, and mental wellbeing, sleep, and metabolic parameters. Other outcomes that are assessed include the FiberScreen tool, the form of human faeces (Bristol Stool Chart), side effects and the defined daily dosis (DDD) of antipsychotic medication.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026