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OpenTrials
Completed

NCT Number: NCT03127176

Dysbiosis in Bipolar Disorder

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clínic Barcelona

Barcelona, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Genome sequencing of fecal samples

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • Institut d'Investigacions Biomèdiques August Pi i Sunyer
  • Instituto de Salud Carlos III

Registry information

Official study title

Dysbiosis in Bipolar Disorder: MicrObiota Bipolar Study

Acronym: MOB

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 25, 2017
Registry last updated
Aug 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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