Bipolar DisorderMOBNCT03127176
Dysbiosis in Bipolar Disorder
An observational study of Bipolar Disorder, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The gut microbiota is a complex community comprising around 10^14 bacteria that live in the gut lumen. The imbalance of the normal structure and function of the microbiota, defined as dysbiosis, has been related to a wide diversity of pathologies, including mental health disorders. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Genome sequencing of fecal samples
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2019to 30 Jun 2021
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects with BD will be recruited in the Bipolar Unit outpatient clinic in the Hospital Clinic of Barcelona. Healthy volunteers will be selected from the community.
Who may be able to join
- Patients:
- Diagnosis of bipolar disorder type I or II according to DSM-IV criteria (SCID);
- Age between 18-55 years;
- Euthymia (YMRS<6 and HMDRS<8) for at least 3 months;
- Signed informed consent.
- Healthy controls:
Show all 9Show fewer
- No psychiatric diagnosis (SCID);
- Age between 18-55 years; euthymia (YMRS<6 and HMDRS<8);
- Signed informed consent.
Who cannot join
- Use of any type of antibiotics, antifungals or pro/prebiotics within at least one month prior to recruitment;
- IQ<85;
- Neurological illness;
- Stomach/gut problems;
- Current diagnosis of substance abuse or dependence according to DSM-IV criteria (SCID);
- Electroconvulsive therapy in the last year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dysbiosis in Bipolar Disorder: MicrObiota Bipolar Study
The gut microbiota is a complex community comprising around 10^14 bacteria that live in the gut lumen. The imbalance of the normal structure and function of the microbiota, defined as dysbiosis, has been related to a wide diversity of pathologies, including mental health disorders. However, clinical evidence of the relationship between microbiota and mood disorders is lacking. The aim of this project is to examine the possible relationship of gut dysbiosis and the diagnosis of bipolar disorder (BD), of gut dysbiosis and mood relapses and of gut dysbiosis and cognitive impairment in bipolar patients.
Read the detailed description
A prospective longitudinal study will be carried out with three groups of patients: a group of euthymic bipolar I or II patients without cognitive impairment (n=50), a second group of euthymic bipolar I or II patients with cognitive impairment (n=50) and a control group of healthy volunteers (n=50). Cognitive impairment will be defined as performance in any test of a domain below 2 standard deviations or more from the mean of normative data of each test assessed in the control group. Subjects will be recruited in the Hospital Clinic of Barcelona. At baseline clinical variables and diet patterns (ROME III) will be collected and neuropsychological performance (WCST, FAS, Stroop Colour-Word Interference test, TMT, WAIS-III, CVLT-II) and functionality (FAST) will be assessed. All subjects will be reassessed at 12 months follow-up. The mood state and possible affective relapses will be evaluated and treatments will be registered. All patients will receive standard psychiatric care according to international guidelines on bipolar disorders. Fecal samples will be collected and then frozen in the morning pre-prandial after having fasted overnight. DNA will be separated and stored at -80°C until assayed. Sequencing will be performed on an Illumina MiSeqTM platform. Statistical analysis will be performed with the latest existing version of the SPSS.
- Conditions
- Bipolar Disorder
- Being tested
- Genome sequencing of fecal samples
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genome sequencing of fecal samplesOther
Fecal samples will be collected and then frozen in the morning pre-prandial after having fasted overnight. DNA will be separated and stored at -80°C in our center (Biobanc) until assayed. Sequencing will be performed with the most appropriate platform.
| Study group | Role | What they receive |
|---|---|---|
| BD with cognitive impairment | This group will include euthymic patients with bipolar disorder type I or II (YMRS<6 and HMDRS<8) and cognitive impairment.
Intervention: Genome sequencing of fecal samples Receives: Other: Genome sequencing of fecal samples | |
| BD without cognitive impairment | This group will include euthymic patients with bipolar disorder type I or II (YMRS<6 and HMDRS<8) without cognitive impairment.
Intervention: Genome sequencing of fecal samples Receives: Other: Genome sequencing of fecal samples | |
| Control group | This group will include healthy volunteers. Intervention: Genome sequencing of fecal samples Receives: Other: Genome sequencing of fecal samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composition of the gut microbiota.
To determine if patients diagnosed with BD present gut dysbiosis compared to controls through genome sequencing of fecal samples.
Measured: 12 months
Secondary outcomes (2)
Composition of the gut microbiota according to mood state.
Gut dysbiosis will be determined according to mood state, assessed using clinical evaluation.
Measured: 12 months
Composition of the gut microbiota according to cognitive state.
Gut dysbiosis will be determined according to cognitive state, assessed using a pre-defined neuropsychological battery.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start1 Oct 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Institut d'Investigacions Biomèdiques August Pi i Sunyer, Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Iria Grande, Hospital Clinic of Barcelona
- Investigators
- Iria Grande, MD, PhD, Principal investigator, Bipolar Disorders Unit, Hospital Clinic, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03127176
- Sponsor's protocol ID
- PI 16/00187
- Acronym
- MOB
- Status last verified
- Aug 2021
- First submitted
- 29 Mar 2017
- Last updated
- 26 Aug 2021
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysbiosis in Bipolar Disorder: MicrObiota Bipolar Study
- ClinicalTrials.gov ID
- NCT03127176
- Acronym / sponsor ID
- MOB / PI 16/00187
- Conditions
- Bipolar Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Institut d'Investigacions Biomèdiques August Pi i Sunyer, Instituto de Salud Carlos III
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 25 Apr 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 gut microbiota is a complex community comprising around 10^14 bacteria that live in the gut lumen. The imbalance of the normal structure and function of the microbiota, defined as dysbiosis, has been related to a wide diversity of pathologies, including mental health disorders. However, clinical evidence of the relationship between microbiota and mood disorders is lacking. The aim of this project is to examine the possible relationship of gut dysbiosis and the diagnosis of bipolar disorder (BD), of gut dysbiosis and mood relapses and of gut dysbiosis and cognitive impairment in bipolar patients.
Detailed description
A prospective longitudinal study will be carried out with three groups of patients: a group of euthymic bipolar I or II patients without cognitive impairment (n=50), a second group of euthymic bipolar I or II patients with cognitive impairment (n=50) and a control group of healthy volunteers (n=50). Cognitive impairment will be defined as performance in any test of a domain below 2 standard deviations or more from the mean of normative data of each test assessed in the control group. Subjects will be recruited in the Hospital Clinic of Barcelona. At baseline clinical variables and diet patterns (ROME III) will be collected and neuropsychological performance (WCST, FAS, Stroop Colour-Word Interference test, TMT, WAIS-III, CVLT-II) and functionality (FAST) will be assessed. All subjects will be reassessed at 12 months follow-up. The mood state and possible affective relapses will be evaluated and treatments will be registered. All patients will receive standard psychiatric care according to international guidelines on bipolar disorders. Fecal samples will be collected and then frozen in the morning pre-prandial after having fasted overnight. DNA will be separated and stored at -80°C until assayed. Sequencing will be performed on an Illumina MiSeqTM platform. Statistical analysis will be performed with the latest existing version of the SPSS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BD with cognitive impairment | – | Other: Genome sequencing of fecal samplesThis group will include euthymic patients with bipolar disorder type I or II (YMRS<6 and HMDRS<8) and cognitive impairment. Intervention: Genome sequencing of fecal samples |
| BD without cognitive impairment | – | Other: Genome sequencing of fecal samplesThis group will include euthymic patients with bipolar disorder type I or II (YMRS<6 and HMDRS<8) without cognitive impairment. Intervention: Genome sequencing of fecal samples |
| Control group | – | Other: Genome sequencing of fecal samplesThis group will include healthy volunteers. Intervention: Genome sequencing of fecal samples |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects with BD will be recruited in the Bipolar Unit outpatient clinic in the Hospital Clinic of Barcelona. Healthy volunteers will be selected from the community.
Key inclusion criteria (9 listed)
- Patients:
- Healthy controls:
Key exclusion criteria (6 listed)
- Use of any type of antibiotics, antifungals or pro/prebiotics within at least one month prior to recruitment;
- IQ<85;
- Neurological illness;
- Stomach/gut problems;
- Current diagnosis of substance abuse or dependence according to DSM-IV criteria (SCID);
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 |
|---|---|---|
| Genome sequencing of fecal samplesFecal samples will be collected and then frozen in the morning pre-prandial after having fasted overnight. DNA will be separated and stored at -80°C in our center (Biobanc) until assayed. Sequencing will be performed with the most appropriate platform. | Other | BD with cognitive impairment, BD without cognitive impairment, Control group |
Primary outcome
Composition of the gut microbiota.
Time frame: 12 months
To determine if patients diagnosed with BD present gut dysbiosis compared to controls through genome sequencing of fecal samples.
2 secondary outcomes
Composition of the gut microbiota according to mood state.
Time frame: 12 months
Composition of the gut microbiota according to cognitive state.
Time frame: 12 months
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 26 Aug 2021.
- 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.
Iria Grande, MD, PhD principal investigator
Bipolar Disorders Unit, Hospital Clinic, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM
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 Bipolar Disorder, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 9 inclusion and 6 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 26 Aug 2021. 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 Spain. 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?
Composition of the gut microbiota. (time frame: 12 months). 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 26 Aug 2021.