The main objective of this study is to assess the potential beneficial effects of the prebiotic Galacto-oligosaccharides (GOS) in combination with 2*-fucosyllactose (2*-FL) on the gut microbiota, by showing a relative increase in Bifidobacteria in…
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the change in Bifidobacteria in fecal samples from week
0 to week 6.
Secondary outcome
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.
Background summary
Atypical antipsychotic (AAP) drugs are the gold-standard treatment for
psychotic patients but are nowadays also widely prescribed among people with
other mental disorders (Morrens, Destoop, Cleymans, S, & Dom, 2015).
Notwithstanding the benefits of AAP in terms of symptom improvement, there are
severe adverse effects including the metabolic syndrome (van Alphen et al.,
2012). A novel hypothesis is that part of these undesirable effects of
antipsychotics could be mediated by their deleterious effects on the microbiome
(Maier et al., 2018). This may result in dysbiosis, the disruption of bacterial
species of the gut microbiota. Recently, dysbiosis has been linked to poor
quality of life, depression and anxiety through the gut-brain axis
(Valles-Colomer et al., 2019). Mounting evidence proposes that prebiotic
consumption may be helpful in the recovery of dysbiosis, although this effect
is unclear among long-term antipsychotic users.
Study objective
The main objective of this study is to assess the potential beneficial effects
of the prebiotic Galacto-oligosaccharides (GOS) in combination with 2*-
fucosyllactose (2*-FL) on the gut microbiota, by showing a relative increase in
Bifidobacteria in fecal samples following intervention.
Study design
The study is a single-arm pilot study (non-randomized and non-blinded).
Intervention
Following a run-in period of 4 weeks (no intervention but all other aspects of
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
morning) for 42 days.
Study burden and risks
Patients who wish to participate fill out questionnaires (30 min) at 5 points
(t0, t1, t2, t3, and t4). Also, we collect data via sampling of feces,
measurements of weight, height and waist circumference (20 min). Data
collection will take a maximum of 60 minutes per measurement moment and take
place where the participants receive care. Based on literature, GOSplus is safe
to use, however the participants can experience, often temporary, some
flatulence and bloating as is often seen with prebiotic consumption. Due to the
potential of GOSplus to decrease stress, the quality of life and metabolic
health may increase in the patients recruited for this study.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
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
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81636.058.22 |