Dysbiosis in Bipolar Disorder

NCT ID: NCT03127176

Last Updated: 2021-08-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2021-06-30

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.

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Genome sequencing of fecal samples

Intervention Type: OTHER

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

Genome sequencing of fecal samples

Intervention Type: OTHER

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

Genome sequencing of fecal samples

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut d'Investigacions Biomèdiques August Pi i Sunyer

OTHER

Sponsor Role: collaborator

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Iria Grande

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Iria Grande, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Bipolar Disorders Unit, Hospital Clinic, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM

Locations

Hospital Clínic Barcelona

Barcelona, , Spain

Countries

Spain

Other Identifiers

PI 16/00187

Identifier Type: -

Identifier Source: org_study_id