NCT03127176

Dysbiosis in Bipolar Disorder

Dysbiosis in Bipolar Disorder: MicrObiota Bipolar Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-10-01
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2017-04-25
• Last updated: 2021-08-26

Locations

1 site across 1 country: Spain