SchizophreniaPrepsyNCT03153046
The Effects of Prebiotics on Cognitive Functioning and Weight Gain in Psychosis
A study testing prebiotics and Maltodextrin in people with Schizophrenia, run by University of Oxford at 1 site in United Kingdom.
Trial summary
The investigators propose a maltodextrin-controlled cross over experimental medicine study that aims to examine the role of the immune system in cognitive processes and weight gain in 40 adult patients with psychosis, stable on antipsychotic medication for over 1 month. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- prebiotics and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 May 2017to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or Female, aged 18-60 years of age.
- Participant is willing and able to give informed consent for participation in the study
- Diagnosed with psychotic disorder ICD-10 (e.g., schizophrenia, schizoaffective disorder, psychosis NOS)
- Stable on psychotropic medication for >1 month with cognitive deficits (Cognitive deficits will be evaluated using the BACS test cut off score of 1.0 standard deviation below the healthy mean; those that score within the normal range i.e., within 1.0 standard deviations of the mean are not considered cognitively impaired and thus will not be included in the study)
Who cannot join
- Not considered suitable for the study by the clinical team, for whatever reason
- Current inpatient in psychiatric hospital
- Additional major medical disorders (including diseases affecting the human gastrointestinal tract and blood-borne disorders)
- Antibiotic, probiotic and/or prebiotic treatment in at least the 3 previous months
- Participants who are taking any other food supplements which, in the opinion of the Investigators, may affect the results
- Participants who have a known intolerance to lactose (self-identified)
- Any significant recent change in diet which, to the discretion of the Investigators, may affect the results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Modulating the Immune System With Prebiotics on Cognition and Weight in Patients With Psychosis
The investigators propose a maltodextrin-controlled cross over experimental medicine study that aims to examine the role of the immune system in cognitive processes and weight gain in 40 adult patients with psychosis, stable on antipsychotic medication for over 1 month. There is evidence suggesting the immune system is linked to brain function and weight gain, both parameters that has been implicated in psychosis and antipsychotic use, and may underlie some schizophrenic features. The fermentation of galacto-oligosaccharides (GOS), which are short chain carbohydrates composed mostly of galactose sugar molecules, by the intestinal microbiota has been shown to modulate the immune system and reduce the inflammatory response in both animals and humans. Since the intestinal ecosystem is highly sensitive to dietary changes, the growth of beneficial gut bacteria can be enhanced using a natural food supplement similar to GOS known as prebiotics. The study will be controlled by taking maltodextrin as a control supplement. Both prebiotics and maltodextrin are short chain sugar compounds. The study will involve asking patients to take dietary supplement for a total of 24 weeks; GOS for 12 weeks and maltodextrin for 12 weeks as a control. Participants will be randomised into groups, with half receiving maltodextrin followed by GOS, and half receiving GOS followed by maltodextrin. Participants will be assessed on cognitive function and weight gain at 3 specified time points.
Read the detailed description
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.
- Conditions
- Schizophrenia
- Being tested
- prebiotics, Maltodextrin
- Keywords
- prebiotics, cognitive impairment, weight gain
- Medical subject headings
- Schizophrenia, Cognitive Dysfunction, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prebioticsDietary supplement
Also called Bimuno® galacto-oliogosaccharides (BGOS)
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.
MaltodextrinDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Prebiotics | Experimental | 12 week ingestion of prebiotics, Bimuno galacto-oligosaccharide (B-GOS). Receives: Dietary Supplement: prebiotics |
| Maltodextrin | Placebo comparator | 12 week ingestion of maltodextrin Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Assessments using the BAC's Test
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.
Measured: 1 year
Secondary outcomes (3)
Body Mass Index (BMI)
Weight in kilograms and height in meters will be measured to calculate the BMI kg/m^2 of a participant.
Measured: 1 year
Waist-Hip Ratio
Waist and hip circumference will be measured in centimeters where the Waist-to-Hip ratio will calculated.
Measured: 1 year
Circulating Inflammatory Markers
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start8 May 2017
- Primary completion30 Sep 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 24 week cross-over at 12 week involving preiotics and maltodextrin
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Clasado Biosciences Ltd
- Responsible party
- Sponsor
- Investigators
- Belinda Lennox, MD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153046
- Sponsor's protocol ID
- 12302
- Acronym
- Prepsy
- Status last verified
- May 2018
- First submitted
- 2 May 2017
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kao AC, Safarikova J, Marquardt T, Mullins B, Lennox BR, Burnet PWJ. Pro-cognitive effect of a prebiotic in psychosis: A double blind placebo controlled cross-over study. Schizophr Res. 2019 Jun;208:460-461. doi: 10.1016/j.schres.2019.03.003. Epub 2019 Mar 12. No abstract available.
PubMed 30876680
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Modulating the Immune System With Prebiotics on Cognition and Weight in Patients With Psychosis
- ClinicalTrials.gov ID
- NCT03153046
- Acronym / sponsor ID
- Prepsy / 12302
- Conditions
- Schizophrenia
- Keywords
- prebiotics, cognitive impairment, weight gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Clasado Biosciences Ltd
- Study start
- 8 May 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 15 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose a maltodextrin-controlled cross over experimental medicine study that aims to examine the role of the immune system in cognitive processes and weight gain in 40 adult patients with psychosis, stable on antipsychotic medication for over 1 month. There is evidence suggesting the immune system is linked to brain function and weight gain, both parameters that has been implicated in psychosis and antipsychotic use, and may underlie some schizophrenic features. The fermentation of galacto-oligosaccharides (GOS), which are short chain carbohydrates composed mostly of galactose sugar molecules, by the intestinal microbiota has been shown to modulate the immune system and reduce the inflammatory response in both animals and humans. Since the intestinal ecosystem is highly sensitive to dietary changes, the growth of beneficial gut bacteria can be enhanced using a natural food supplement similar to GOS known as prebiotics. The study will be controlled by taking maltodextrin as a control supplement. Both prebiotics and maltodextrin are short chain sugar compounds. The study will involve asking patients to take dietary supplement for a total of 24 weeks; GOS for 12 weeks and maltodextrin for 12 weeks as a control. Participants will be randomised into groups, with half receiving maltodextrin followed by GOS, and half receiving GOS followed by maltodextrin. Participants will be assessed on cognitive function and weight gain at 3 specified time points.
Detailed description
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 24 week cross-over at 12 week involving preiotics and maltodextrin
| Arm | Type | Receives |
|---|---|---|
| Prebiotics | Experimental | Dietary Supplement: prebiotics12 week ingestion of prebiotics, Bimuno galacto-oligosaccharide (B-GOS). |
| Maltodextrin | Placebo comparator | Dietary Supplement: Maltodextrin12 week ingestion of maltodextrin |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or Female, aged 18-60 years of age.
- Participant is willing and able to give informed consent for participation in the study
- Diagnosed with psychotic disorder ICD-10 (e.g., schizophrenia, schizoaffective disorder, psychosis NOS)
- Stable on psychotropic medication for >1 month with cognitive deficits (Cognitive deficits will be evaluated using the BACS test cut off score of 1.0 standard deviation below the healthy mean; those that score within the normal range i.e., within 1.0 standard deviations of the mean are not considered cognitively impaired and thus will not be included in the study)
Key exclusion criteria (7 listed)
- Not considered suitable for the study by the clinical team, for whatever reason
- Current inpatient in psychiatric hospital
- Additional major medical disorders (including diseases affecting the human gastrointestinal tract and blood-borne disorders)
- Antibiotic, probiotic and/or prebiotic treatment in at least the 3 previous months
- Participants who are taking any other food supplements which, in the opinion of the Investigators, may affect the results
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prebioticsAlso: Bimuno® galacto-oliogosaccharides (BGOS)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. | Dietary supplement | Prebiotics |
| MaltodextrinMaltodextrin 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. | Dietary supplement | Maltodextrin |
Primary outcome
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.
3 secondary outcomes
Body Mass Index (BMI)
Time frame: 1 year
Waist-Hip Ratio
Time frame: 1 year
Circulating Inflammatory Markers
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Results publication: PubMed 30876680Kao AC, Safarikova J, Marquardt T, Mullins B, Lennox BR, Burnet PWJ. Pro-cognitive effect of a prebiotic in psychosis: A double blind placebo controlled cross-over study. Schizophr Res. 2019 Jun;208:460-461. doi: 10.1016/j.schres.2019.03.003. Epub 2019 Mar 12. No abstract available.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Belinda Lennox, MD principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prebiotics and Maltodextrin in people with Schizophrenia, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Assessments using the BAC's Test (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03153046, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.