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Dysbiosis in Bipolar Disorder (MOB)

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ClinicalTrials.gov Identifier: NCT03127176
Recruitment Status : Not yet recruiting
First Posted : April 25, 2017
Last Update Posted : February 23, 2018
Sponsor:
Collaborators:
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Iria Grande, Hospital Clinic of Barcelona

Brief 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. 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.

Condition or disease Intervention/treatment
Bipolar Disorder Other: Genome sequencing of fecal samples

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 Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Dysbiosis in Bipolar Disorder: MicrObiota Bipolar Study
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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

Other: Genome sequencing of fecal samples
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.

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

Other: Genome sequencing of fecal samples
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.

Control group
This group will include healthy volunteers. Intervention: Genome sequencing of fecal samples
Other: Genome sequencing of fecal samples
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Composition of the gut microbiota according to mood state. [ Time Frame: 12 months ]
    Gut dysbiosis will be determined according to mood state, assessed using clinical evaluation.

  2. Composition of the gut microbiota according to cognitive state. [ Time Frame: 12 months ]
    Gut dysbiosis will be determined according to cognitive state, assessed using a pre-defined neuropsychological battery.


Biospecimen Retention:   Samples With DNA
Stool sample


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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:

    • No psychiatric diagnosis (SCID);
    • Age between 18-55 years; euthymia (YMRS<6 and HMDRS<8);
    • Signed informed consent.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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): NCT03127176


Contacts
Contact: Iria Grande, MD, PhD 0034 93 227 54 00 ext 3130 igrande@clinic.cat

Locations
Spain
Hospital Clínic Barcelona Not yet recruiting
Barcelona, Spain, 08036
Contact: Iria Grande, MD, PhD    0034 93 227 54 00 ext 3130    igrande@clinic.cat   
Sponsors and Collaborators
Hospital Clinic of Barcelona
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Instituto de Salud Carlos III
Investigators
Principal Investigator: Iria Grande, MD, PhD Bipolar Disorders Unit, Hospital Clinic, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM

Responsible Party: Iria Grande, Principal Investigator, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT03127176     History of Changes
Other Study ID Numbers: PI 16/00187
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Dysbiosis
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders