Dysbiosis in Bipolar Disorder

NCT03127176 | Completed

• 1 other identifier: PI 16/00187
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Composition of the gut microbiota.

  To determine if patients diagnosed with BD present gut dysbiosis compared to controls through genome sequencing of fecal samples.

  12 months

Secondary Outcomes (2)

• Composition of the gut microbiota according to mood state.

  12 months

• Composition of the gut microbiota according to cognitive state.

  12 months

Study Arms (3)

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

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

Control group

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

Other: Genome sequencing of fecal samples

Interventions

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.

BD with cognitive impairment; BD without cognitive impairment; Control group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• Institut d'Investigacions Biomèdiques August Pi i Sunyer: collaborator
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Hospital Clínic Barcelona

Barcelona, 08036, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool sample

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Iria Grande, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 25, 2017
• Study Start: October 1, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: August 26, 2021

Record last verified: 2021-08

Locations

ES (1)