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Effect of Probiotic vs Placebo on Cognition Outcomes in Patients With Bipolar Disorder - Trial NCT05954598

Access comprehensive clinical trial information for NCT05954598 through Pure Global AI's free database. This phase not specified trial is sponsored by First Affiliated Hospital of Zhejiang University and is currently Recruiting. The study focuses on Bipolar Disorder. Target enrollment is 100 participants.

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NCT05954598
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dietary supplement
Trial Details
ClinicalTrials.gov โ€ข NCT05954598
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Effect of Probiotic vs Placebo on Cognition Outcomes in Patients With Bipolar Disorder
Effect of Probiotic vs Placebo on Cognition Outcomes in Patients With Bipolar Disorder: A Randomized Clinical Trial

Study Focus

Bipolar Disorder

probiotic

Interventional

dietary supplement

Sponsor & Location

First Affiliated Hospital of Zhejiang University

Hangzhou, China

Timeline & Enrollment

N/A

May 01, 2022

Dec 01, 2024

100 participants

Primary Outcome

Scores change from Baseline the number symbol test at 24 weeks

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.

ICD-10 Classifications

Bipolar affective disorder
Bipolar affective disorder, unspecified
Other bipolar affective disorders
Bipolar affective disorder, currently in remission
Bipolar affective disorder, current episode mixed

Data Source

ClinicalTrials.gov

NCT05954598

Non-Device Trial