The Effects of Prebiotics on Cognitive Functioning and Weight Gain in Psychosis (Prepsy)
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|ClinicalTrials.gov Identifier: NCT03153046|
Recruitment Status : Completed
First Posted : May 15, 2017
Last Update Posted : April 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Dietary Supplement: prebiotics Dietary Supplement: Maltodextrin||Not Applicable|
An 24-week maltodextrin-control cross-over experimental medicine study enrolling 40 patients with psychosis. Participants will receive a 12-week treatment with Bimuno™ GOS, as well as a 12-week maltodextrin supplement. The order of supplements that participants will receive is randomized. A washout period was considered unnecessary as maltodextrin is an inactive placebo wherein negligible effects have been shown on bifidobacteria growth, and therefore, would present with no carryover/lasting effects to mask the prebiotic effect.
Eligible patients will be invited to be screened for the study and assessed to ensure they meet inclusion/exclusion criteria. If the participant passes this initial screening stage and conditional to informed consent, he/she will then be randomized into one of the two groups. Once decided, the participant will be assessed by a research assistant using standard clinical assessments used to diagnose/evaluate cognitive deficits. A 12-week supply of sachets containing prebiotic or maltodextrin will be provided for the participant to allow participants to complete the first quarter of the study. Additional 12-week supplies of prebiotics or maltodextrin will be provided at the study follow-up. Since clozapine/olanzapine are well known antipsychotics that induce weight gain and interfere with the immune system an additional sub-analysis of those participants stable on clozapine/olanzapine will be performed, contingent on the demographics.
The study will include five sessions in total all taking place at either University Department of Psychiatry, Warneford Hospital, or a location convenient to the participant (e.g., patient home): (1) screening session, (2) baseline cognitive and blood measurements, (3) study follow up, and (4) final testing session.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||24 week cross-over at 12 week involving preiotics and maltodextrin|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Blinding of compounds will be provided by Clasado Ltd., the company supplying the prebiotics and maltodextrin.|
|Official Title:||Effects of Modulating the Immune System With Prebiotics on Cognition and Weight in Patients With Psychosis|
|Actual Study Start Date :||May 8, 2017|
|Actual Primary Completion Date :||September 30, 2018|
|Actual Study Completion Date :||December 30, 2018|
12 week ingestion of prebiotics, Bimuno galacto-oligosaccharide (B-GOS).
Dietary Supplement: prebiotics
Bimuno (BGOS): The active supplement of the food supplement (Bimuno) used in this study is called galacto‐oliogosaccharides (Bimuno®, BGOS). BGOS is a compound metabolised by specific bifidobacteria, which are beneficial bacteria, in our colon. Bimuno (2.3 calories) is composed by the following ingredients per gram of Bimuno: 0.96g dry matter; <01g Fat; <0.06g Protein; 0.821g GOS; 0.119g Lactose; 0.0331g Glucose and 0.0029g Galactose. Bimuno is tasteless. Bimuno will be supplied in coded sachets (3.5g) for dispensing by parents. Each participant will be required to consume 1 sachet daily during breakfast, by mixing it with food or in a drink.
Other Name: Bimuno® galacto-oliogosaccharides (BGOS)
Placebo Comparator: Maltodextrin
12 week ingestion of maltodextrin
Dietary Supplement: Maltodextrin
Maltodextrin is a polysaccharide in powder form, which grows most bacteria in the gut, and not specifically the beneficial bifidobacteria. The placebo will also be provided in daily coded sachets (3.5g) for dispensing by parents. Each participant will be required to consume 1 sachet daily during breakfast, by mixing it with food or in a drink. This placebo has been used in previous studies, in which Bimuno was used as the active intervention. The placebo will be similar in taste and colour to the active intervention.
- Cognitive Assessments using the BAC's Test [ Time Frame: 1 year ]The Brief Assessment of Cognition (BAC), developed by NeuroCog. Trials, assesses five different domains of cognitive function with six tests (i.e., Verbal Memory & Learning (Verbal Memory), Working Memory (Digit Sequencing), Motor Function (Token Motor Task), Verbal Fluency (Semantic and Letter Fluency), Speed of Processing (Symbol Coding), and Executive Function (Tower of London)). Outcome measures from each test will be combined into one composite Z-Score, and transformed into a T-Score to evaluate global cognition on a standardise curve.
- Body Mass Index (BMI) [ Time Frame: 1 year ]Weight in kilograms and height in meters will be measured to calculate the BMI kg/m^2 of a participant.
- Waist-Hip Ratio [ Time Frame: 1 year ]Waist and hip circumference will be measured in centimeters where the Waist-to-Hip ratio will calculated.
- Circulating Inflammatory Markers [ Time Frame: 1 year ]Collected venous blood will be spun down to isolate plasma wherein biochemical tests examining inflammatory markers including interleukin-1b, tumour necrosis factor alpha, interleukin-8 and acetate will be evaluated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03153046
|Oxford, Oxfordshire, United Kingdom, OX3 7JX|
|Principal Investigator:||Belinda Lennox, MD||University of Oxford|