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NCT05954598Recruiting

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
First Affiliated Hospital of Zhejiang UniversityClinicalTrials.govdietary supplement
Verified
Study focus
Disease/Condition
Bipolar Disorder
Drug/Device/Intervention
probiotic
Study type
Interventional
Intervention type
dietary supplement
Sponsor & location
Primary sponsor
First Affiliated Hospital of Zhejiang University
Location
Hangzhou, China
Timeline & enrollment
Phase
N/A
Start date
May 01, 2022
End date
Dec 01, 2024
Enrollment
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 disorderBipolar affective disorder, unspecifiedOther bipolar affective disordersBipolar affective disorder, currently in remissionBipolar affective disorder, current episode mixed
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05954598
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.