Bipolar DisorderNCT05954598
Effect of Probiotic vs Placebo on Cognition Outcomes in Patients With Bipolar Disorder
A study testing probiotic in people with Bipolar Disorder, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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;
Show all 9Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU)
Hangzhou, Zhejiang
Xiao Wang, MD
About this study
Official title: Effect of Probiotic vs Placebo on Cognition Outcomes in Patients With Bipolar Disorder: A Randomized Clinical Trial
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.
Read the 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
- Being tested
- probiotic
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probioticDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| probiotic | Experimental | 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 Receives: Dietary Supplement: probiotic |
| placebo | Placebo comparator | 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 Receives: Dietary Supplement: probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores change from Baseline the number symbol test at 24 weeks
Measured: week0，week8，week12，week24
Secondary outcomes (6)
Visuospatial function
Scores change from Baseline the short visuospatial memory test at 24 weeks
Measured: week0，week8，week12，week24
Working memory
Scores change from Baseline the Spatial span test at 24 weeks
Measured: week0，week8，week12，week24
MRI (Functional connectivity, network features)
change from Baseline the Functional connectivity and network features at 12 weeks
Measured: week0，week12，
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
Measured: week0，week8，week12，week24
Sleep
change from Baseline the Sleep Quality Questionnaire (PSQI) at 24 weeks
Measured: week0，week8，week12，week24
Changes in serum cortisol levels
Changes from Baseline serum cortisol levels at 24 weeks
Measured: week0，week8，week12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start1 May 2022
- Primary completion1 May 2022
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu ShaoHua, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954598
- Sponsor's protocol ID
- IIT20220105C-R1
- Status last verified
- Jul 2023
- First submitted
- 4 Jul 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotic vs Placebo on Cognition Outcomes in Patients With Bipolar Disorder: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05954598
- Acronym / sponsor ID
- IIT20220105C-R1
- Conditions
- Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotic | Experimental | Dietary Supplement: probioticThe 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 |
| placebo | Placebo comparator | Dietary Supplement: probioticThe 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 |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| probioticThis 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. | Dietary supplement | placebo, probiotic |
Primary outcome
Scores change from Baseline the number symbol test at 24 weeks
Time frame: week0，week8，week12，week24
6 secondary outcomes
Visuospatial function
Time frame: week0，week8，week12，week24
Working memory
Time frame: week0，week8，week12，week24
MRI (Functional connectivity, network features)
Time frame: week0，week12，
Somatic symptoms
Time frame: week0，week8，week12，week24
Sleep
Time frame: week0，week8，week12，week24
Changes in serum cortisol levels
Time frame: week0，week8，week12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotic in people with Bipolar Disorder, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao Wang, MD (13685720165, miriamyoung@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores change from Baseline the number symbol test at 24 weeks (time frame: week0，week8，week12，week24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.