The Effect of Probiotics in Treatment of Bipolar Disorder.

Evaluating the Effect of Probiotics Augment in Treatment of Bipolar Disorder.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180819040836N1

Enrollment

Registered

2018-10-02

Start date

2018-05-31

Completion date

Unknown

Last updated

2018-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 bipolar disorder. Bipolar disorder

Interventions

Intervention 1: Intervention group: Patients with type 1 bipolar disorder who are treated with a probiotic capsule(Bioflora) for 2 months. Intervention 2: Control group: Patients with type 1 bipolar d

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Detection of type 1 bipolar disorder based on DSM5. Age 18 to 65 years old. No change in dosage of antipsychotics, lithium and sodium valproate in the 2 weeks prior to entering the study and during treatment.

Exclusion criteria

Exclusion criteria: Pregnancy and Lactation. Hypersensivity to lactose. Chronic diseases (heart, kidney, lung and liver). Use of supplements and probiotics in the last 2 months. Schizophrenia and other psychotic disorders. seizure.

Design outcomes

Primary

Measure	Time frame
Determination of serum IL-6 concentration. Timepoint: Measurement of serum IL-6 concentration at baseline,1month and 2 months later. Method of measurement: A kit for measuring serum levels of IL-6.;Determination of serum IL-10 concentration. Timepoint: Measurement of serum IL-10 concentration at baseline, 1 month and 2 months later. Method of measurement: A kit for measuring serum levels of IL-10.;Determination of serum TNF-a concentration. Timepoint: Measurement of serum TNF-a concentration at baseline, 1 month and 2 months later. Method of measurement: A kit for measuring serum levels of TNF-a.	—

Measure

Time frame

Determination of serum IL-6 concentration. Timepoint: Measurement of serum IL-6 concentration at baseline,1month and 2 months later. Method of measurement: A kit for measuring serum levels of IL-6.;Determination of serum IL-10 concentration. Timepoint: Measurement of serum IL-10 concentration at baseline, 1 month and 2 months later. Method of measurement: A kit for measuring serum levels of IL-10.;Determination of serum TNF-a concentration. Timepoint: Measurement of serum TNF-a concentration at baseline, 1 month and 2 months later. Method of measurement: A kit for measuring serum levels of TNF-a.

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Secondary

Measure	Time frame
Hamilton Scale of Depression Scale. Timepoint: At the start of the study, one month and two months later. Method of measurement: Based on the Hamilton Depression Questionnaire.;Scale Young Mania Scale. Timepoint: At the start of the study, one month and two months later. Method of measurement: Based on Young Mania Questionnaire.;Improvement of Mania Symptoms and Depression. Timepoint: At the start of the study, one month and two months later. Method of measurement: Based on the Clinical Global Impression and Impronement Bipolar Questionnaire.	—

Measure

Time frame

Hamilton Scale of Depression Scale. Timepoint: At the start of the study, one month and two months later. Method of measurement: Based on the Hamilton Depression Questionnaire.;Scale Young Mania Scale. Timepoint: At the start of the study, one month and two months later. Method of measurement: Based on Young Mania Questionnaire.;Improvement of Mania Symptoms and Depression. Timepoint: At the start of the study, one month and two months later. Method of measurement: Based on the Clinical Global Impression and Impronement Bipolar Questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahdi Esmaeilzadeh

Kerman University of Medical Sciences

m.esmaeilzadeh@kmu.ac.ir+98 34 3211 1006

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026