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

NCT05954598 | Unknown DMC

• 1 other identifier: IIT20220105C-R1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Scores change from Baseline the number symbol test at 24 weeks

  week0，week8，week12，week24

Secondary Outcomes (6)

• Visuospatial function

  week0，week8，week12，week24

• Working memory

  week0，week8，week12，week24

• MRI (Functional connectivity, network features)

  week0，week12，

• Somatic symptoms

  week0，week8，week12，week24

• Sleep

  week0，week8，week12，week24

Study Arms (2)

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

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

Dietary Supplement: probiotic

Interventions

probiotic 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; probiotic

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ）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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

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

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Xiao Wang, MD

CONTACT

13685720165; miriamyoung@126.com

Shaohua Hu, MD

CONTACT

13957162903; dorhushaohua@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 20, 2023
• Study Start: May 1, 2022
• Primary Completion: May 1, 2022
• Study Completion: December 1, 2024
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)