Effect of Probiotic vs Placebo on Cognition Outcomes in Patients With Bipolar Disorder

NCT ID: NCT05954598

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2024-12-31

Brief Summary

Bipolar disorder has a high hospitalization rate, suicide rate and disability rate, and cognitive dysfunction is one of the core clinical symptoms of bipolar disorder. Cognitive recovery has become a new target and a new target for clinical treatment. In recent years, gut microbiome has been recognized as one of the neuropathological mechanisms of bipolar disorder. This study aims to study the effect of probiotics on cognitive function in stable bipolar disorder patients and the possible mechanism of action. A total of 100 patients with stable bipolar disorder were enrolled into the control group and the experimental group in a random double-blind way to evaluate the intestinal microecology, clinical symptom improvement, cognitive function and side effects before and after treatment between the two groups, and further explore the possible mechanism of action of the experimental drug.

Detailed Description

Bipolar disorder has a high hospitalization rate, suicide rate and disability rate, and cognitive dysfunction is one of the core clinical symptoms of bipolar disorder. Cognitive recovery has become a new target and a new target for clinical treatment. In recent years, gut microbiome has been recognized as one of the neuropathological mechanisms of bipolar disorder. This study aims to study the effect of probiotics on cognitive function in stable bipolar disorder patients and the possible mechanism of action. A total of 100 patients with stable bipolar disorder were enrolled into the control group and the experimental group in a random double-blind way. This study was designed as a randomized double-blind controlled study. The enrolled subjects were randomized into two groups: intervention group and waiting intervention group. The intervention group received 12 weeks of probiotic intervention from the start of the study, and the waiting group received 12 weeks of placebo intervention from the start of the study. At the start of the study, both groups received 12 weeks of probiotic intervention. This study to compare the dynamic changes of cognitive function and resting brain network in stable bipolar disorder patients before and after using probiotics, and to compare the changes of physical symptoms, sleep and serum cortisol levels in stable bipolar disorder patients before and after the use of probiotics between the two groups, and further explore the possible mechanism of action of the experimental drug.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

probiotic

The intervention group received 12 weeks of probiotic intervention from the beginning of the study,and at the start of the study at week 13, both groups received 12 consecutive weeks of probiotic intervention

Group Type: EXPERIMENTAL

probiotic

Intervention Type: DIETARY_SUPPLEMENT

This study was designed as a randomized double-blind controlled study. The enrolled subjects were randomized into two groups: intervention group and waiting intervention group. The intervention group received 12 weeks of probiotic intervention from the start of the study, and the waiting group received 12 weeks of placebo intervention from the start of the study. At the start of the study, both groups received 12 weeks of probiotic intervention.

placebo

The waiting group received 12 consecutive weeks of placebo intervention from the start of the study, and at the start of the study at week 13, both groups received 12 consecutive weeks of probiotic intervention

Group Type: PLACEBO_COMPARATOR

probiotic

Intervention Type: DIETARY_SUPPLEMENT

This study was designed as a randomized double-blind controlled study. The enrolled subjects were randomized into two groups: intervention group and waiting intervention group. The intervention group received 12 weeks of probiotic intervention from the start of the study, and the waiting group received 12 weeks of placebo intervention from the start of the study. At the start of the study, both groups received 12 weeks of probiotic intervention.

Interventions

probiotic

This study was designed as a randomized double-blind controlled study. The enrolled subjects were randomized into two groups: intervention group and waiting intervention group. The intervention group received 12 weeks of probiotic intervention from the start of the study, and the waiting group received 12 weeks of placebo intervention from the start of the study. At the start of the study, both groups received 12 weeks of probiotic intervention.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1）Both biological parents were Han. 2) Age 16-65 years old, male or female; 3) The subjects met the DSM-5 clinical diagnostic criteria for bipolar disorder, and the 17-item Hamilton Depression Scale score (HAMD-17) ≤16 points, Hamilton Anxiety Scale score ≤7 points, and Young Mania Scale score ≤5 points were maintained for more than 2 months. All enrolled patients were evaluated by a professional and systematically trained psychiatrist.

Exclusion Criteria

1. Those who meet the DSM-5 diagnostic criteria for schizophrenia, depression, neurodevelopmental disorders, dementia, memory impairment, or other cognitive disabilities;

2. Those who had used ECT before enrollment;

3. Those who currently have serious suicidal thoughts or behaviors, or who are severely agitated;

4. Those who cannot follow the doctor's advice or have no guardian;

5. Pregnant or lactating women, or those planning pregnancy.

6. Patients with abnormal brain structure or any MRI contraindications found by magnetic resonance examination.

7. Mental disorders caused by substance abuse (alcohol, drugs, etc.), people with serious physical diseases, such as thyroid disease, heart disease, abnormal liver and kidney function, etc.; 8）Can not tolerate any probiotic preparations or have a history of allergy.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Hu ShaoHua

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU)

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiao Wang, MD

Role: CONTACT

miriamyoung@126.com

13685720165

Shaohua Hu, MD

Role: CONTACT

dorhushaohua@zju.edu.cn

13957162903

Facility Contacts

Xiao Wang, MD

Role: primary

Other Identifiers

IIT20220105C-R1

Identifier Type: -

Identifier Source: org_study_id