Clinical Trial: Dysbiosis in Bipolar Disorder

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: Dysbiosis in Bipolar Disorder: MicrObiota Bipolar Study

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 Summary: 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.
Sponsor: Hospital Clinic of Barcelona

Current 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.


Original Secondary Outcome: Same as current

Information By: Hospital Clinic of Barcelona

Dates:
Date Received: March 29, 2017
Date Started: June 2017
Date Completion: December 2019
Last Updated: April 24, 2017
Last Verified: April 2017