Back to resultsEffect of Probiotic vs Placebo on Cognition Outcomes in Patients With Bipolar Disorder
Primary Purpose
Bipolar Disorder
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
probiotic
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder
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. 4) No probiotic preparations such as yogurt were taken within 1 month before enrollment; 5) No clear history of respiratory tract, urinary system, digestive system infection or antibiotic use within 1 month before enrollment; 6) The drug regimen remained stable within 1 month before enrollment; 7) Perceived Deficits Questionnaire (PDQ) score ≥17 points; 8) Right-handed; 9) Primary school education or above; 10) Informed consent of patients and their families to this study. Exclusion Criteria： Those who meet the DSM-5 diagnostic criteria for schizophrenia, depression, neurodevelopmental disorders, dementia, memory impairment, or other cognitive disabilities; Those who had used ECT before enrollment; Those who currently have serious suicidal thoughts or behaviors, or who are severely agitated; Those who cannot follow the doctor's advice or have no guardian; Pregnant or lactating women, or those planning pregnancy. Patients with abnormal brain structure or any MRI contraindications found by magnetic resonance examination. 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.
Sites / Locations
- The First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
probiotic
placebo
Arm Description
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
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
Outcomes
Primary Outcome Measures
Scores change from Baseline the number symbol test at 24 weeks
Secondary Outcome Measures
Visuospatial function
Scores change from Baseline the short visuospatial memory test at 24 weeks
Working memory
Scores change from Baseline the Spatial span test at 24 weeks
MRI (Functional connectivity, network features)
change from Baseline the Functional connectivity and network features at 12 weeks
Somatic symptoms
change from Baseline the Somatic symptoms self-rating scale at 24 weeks，the minimum and maximum values：0-80， higher scores mean a worse outcome
Sleep
change from Baseline the Sleep Quality Questionnaire (PSQI) at 24 weeks
Changes in serum cortisol levels
Changes from Baseline serum cortisol levels at 24 weeks
Full Information
NCT ID
NCT05954598
First Posted
July 4, 2023
Last Updated
July 13, 2023
Sponsor
First Affiliated Hospital of Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05954598
Brief Title
Effect of Probiotic vs Placebo on Cognition Outcomes in Patients With Bipolar Disorder
Official Title
Effect of Probiotic vs Placebo on Cognition Outcomes in Patients With Bipolar Disorder: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
probiotic
Arm Type
Experimental
Arm Description
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
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
probiotic
Intervention Description
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.
Primary Outcome Measure Information:
Title
Scores change from Baseline the number symbol test at 24 weeks
Time Frame
week0，week8，week12，week24
Secondary Outcome Measure Information:
Title
Visuospatial function
Description
Scores change from Baseline the short visuospatial memory test at 24 weeks
Time Frame
week0，week8，week12，week24
Title
Working memory
Description
Scores change from Baseline the Spatial span test at 24 weeks
Time Frame
week0，week8，week12，week24
Title
MRI (Functional connectivity, network features)
Description
change from Baseline the Functional connectivity and network features at 12 weeks
Time Frame
week0，week12，
Title
Somatic symptoms
Description
change from Baseline the Somatic symptoms self-rating scale at 24 weeks，the minimum and maximum values：0-80， higher scores mean a worse outcome
Time Frame
week0，week8，week12，week24
Title
Sleep
Description
change from Baseline the Sleep Quality Questionnaire (PSQI) at 24 weeks
Time Frame
week0，week8，week12，week24
Title
Changes in serum cortisol levels
Description
Changes from Baseline serum cortisol levels at 24 weeks
Time Frame
week0，week8，week12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
4) No probiotic preparations such as yogurt were taken within 1 month before enrollment; 5) No clear history of respiratory tract, urinary system, digestive system infection or antibiotic use within 1 month before enrollment; 6) The drug regimen remained stable within 1 month before enrollment; 7) Perceived Deficits Questionnaire (PDQ) score ≥17 points; 8) Right-handed; 9) Primary school education or above; 10) Informed consent of patients and their families to this study. Exclusion Criteria：
Those who meet the DSM-5 diagnostic criteria for schizophrenia, depression, neurodevelopmental disorders, dementia, memory impairment, or other cognitive disabilities;
Those who had used ECT before enrollment;
Those who currently have serious suicidal thoughts or behaviors, or who are severely agitated;
Those who cannot follow the doctor's advice or have no guardian;
Pregnant or lactating women, or those planning pregnancy.
Patients with abnormal brain structure or any MRI contraindications found by magnetic resonance examination.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao Wang, MD
Phone
13685720165
Email
miriamyoung@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shaohua Hu, MD
Phone
13957162903
Email
dorhushaohua@zju.edu.cn
Facility Information:
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU)
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao Wang, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Probiotic vs Placebo on Cognition Outcomes in Patients With Bipolar Disorder
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