SchizophreniaNCT02921243
Schizophrenia and the Gut Microbiome
An observational study of Schizophrenia and Schizoaffective Disorder, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
In a sample of 20 inpatients with a DSM-IV-TR/DSM 5 diagnosis of schizophrenia or schizoaffective disorder, investigators propose to conduct a prospective, 2 week observational trial to collect gastrointestinal stool samples in order to characterize the microbiota in people with schizophrenia and examine its… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2016to 18 Jun 2019
- Phase
- Observational
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: In-participants with Schizophrenia
Who may be able to join
- DSM-IV-TR /DSM 5 diagnosis of schizophrenia or schizoaffective disorder;
- Age 18-64 years;
- currently hospitalized for at least 7 days
- currently treated with an antipsychotic, with no dose changes in last 14 days
- ability to participate in the informed consent process, as determined by a score of 10 or greater on the Evaluation to Sign Consent
Who cannot join
- Gastrointestinal disorders, including, but not limited to Crohn's Disease, Irritable Bowel Syndrome, Celiac Disease,
- Organic brain disorder, including cerebrovascular accident; epilepsy; traumatic brain injury, Loss of consciousness (LOC) for more than 30 minutes
- Mental retardation
- Antibiotic or immune therapy within the last three months
- Prebiotic or probiotic treatment within the last three months
- Inability to understand English
Show all 10Show fewer
- Inability to cooperate with study procedures
- Pregnant women
- Prisoner status
- For MRI ONLY Contraindication for MRI scanning (e.g. metal in body, pacemaker).
Trial locations and contacts
1 site in 1 country.
United States1 site
Maryland Psychiatric Research Center
Catonsville, Maryland, 21228
About this study
In a sample of 20 inpatients with a DSM-IV-TR/DSM 5 diagnosis of schizophrenia or schizoaffective disorder, investigators propose to conduct a prospective, 2 week observational trial to collect gastrointestinal stool samples in order to characterize the microbiota in people with schizophrenia and examine its variability over time. Participants may elect to participate for an additional two weeks, during which they will receive the prebiotic, oligofructose-enriched inulin (FOS), in order to examine its effects on the relative preponderance of butyrate-producing bacteria in the gut microbiome. Investigators will use an inpatient sample in order to standardize meals, exercise and environmental mediators. This is considered a feasibility, pilot study in order to apply for future grant funding. Investigators will recruit patients from the Treatment Research Program inpatient unit, Maryland Psychiatric Research Center, University of Maryland School of Medicine.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stool Sample Collection | Not described | |
| Prebiotic | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
16S rRNA gene amplicons from stool samples
The 16S rRNA gene amplicon data will be used to examine the relative preponderance of butyrate-producing bacteria in the gut microbiota of people with schizophrenia.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study start1 Oct 2016
- Primary completion18 Jun 2019
- Study completion18 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Buchanan, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921243
- Sponsor's protocol ID
- HP-00069555
- Status last verified
- Aug 2019
- First submitted
- 27 Sep 2016
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Schizophrenia and the Gut Microbiome
- ClinicalTrials.gov ID
- NCT02921243
- Acronym / sponsor ID
- HP-00069555
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 18 Jun 2019 (actual)
- Study completion
- 18 Jun 2019 (actual)
- First posted
- 3 Oct 2016 (estimated)
- 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.
In a sample of 20 inpatients with a DSM-IV-TR/DSM 5 diagnosis of schizophrenia or schizoaffective disorder, investigators propose to conduct a prospective, 2 week observational trial to collect gastrointestinal stool samples in order to characterize the microbiota in people with schizophrenia and examine its variability over time. Participants may elect to participate for an additional two weeks, during which they will receive the prebiotic, oligofructose-enriched inulin (FOS), in order to examine its effects on the relative preponderance of butyrate-producing bacteria in the gut microbiome. Investigators will use an inpatient sample in order to standardize meals, exercise and environmental mediators. This is considered a feasibility, pilot study in order to apply for future grant funding. Investigators will recruit patients from the Treatment Research Program inpatient unit, Maryland Psychiatric Research Center, University of Maryland School of Medicine.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stool Sample Collection | – | – |
| Prebiotic | – | – |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- In-participants with Schizophrenia
Key inclusion criteria (5 listed)
- DSM-IV-TR /DSM 5 diagnosis of schizophrenia or schizoaffective disorder;
- Age 18-64 years;
- currently hospitalized for at least 7 days
- currently treated with an antipsychotic, with no dose changes in last 14 days
- ability to participate in the informed consent process, as determined by a score of 10 or greater on the Evaluation to Sign Consent
Key exclusion criteria (10 listed)
- Gastrointestinal disorders, including, but not limited to Crohn's Disease, Irritable Bowel Syndrome, Celiac Disease,
- Organic brain disorder, including cerebrovascular accident; epilepsy; traumatic brain injury, Loss of consciousness (LOC) for more than 30 minutes
- Mental retardation
- Antibiotic or immune therapy within the last three months
- Prebiotic or probiotic treatment within the last three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
16S rRNA gene amplicons from stool samples
Time frame: 4 weeks
The 16S rRNA gene amplicon data will be used to examine the relative preponderance of butyrate-producing bacteria in the gut microbiota of people with schizophrenia.
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 19 Aug 2019.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Schizoaffective Disorder, run by University of Maryland, Baltimore at 1 site in United States.
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 5 inclusion and 10 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 19 Aug 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 States. 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. 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?
16S rRNA gene amplicons from stool samples (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2019.