Clinical Evaluation of Probiotics on Depression and Gut Microbiota Dysbiosis

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100046321

Enrollment

Unknown

Registered

2021-05-13

Start date

2020-10-01

Completion date

Unknown

Last updated

2021-12-21

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

Conditions

Depression

Interventions

Placebo group:Maltodextrin

Bifidobacterium breve group:1 billion Bifidobacterium breve viable bacterium

Multi-probiotics group:Bifidobacterium breve+Bifidobacterium longum+Pediococcus acidilactici (a total viable bacterium of 3 billion)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.18 years of age and older. 2.Hamilton Depression Scale score higher than 14.

Exclusion criteria

Exclusion criteria: 1.Refractory depression; 2.Other psychiatric diagnoses consistent with DSM-IV axis I; 3.Suicidal, self-injurious behavior; 4.Patients with schizophrenia, bipolar disorder, neurodegenerative diseases; 5.Serious physical diseases, such as HIV, history of epilepsy, history of heart disease, hyperthyroidism and other serious physical diseases; 6.Pregnant or breastfeeding women; 7.Men or women during the preparation period.

Design outcomes

Primary

Measure	Time frame
Hamilton Depression Rating Scale;Montgomery-Asberg Depression Rating Scale;Brief Psychiatric Rating Scale;Gastrointestinal Symptom Rating Scale;fecal microbial analysis;	—

Secondary

Measure	Time frame
serum IL-1ß;serum ACTH;serum cortisol;	—

Countries

China

Contacts

Public ContactWang Gang

Jiangnan University

wanggang@jiangnan.edu.cn+86 15852818722

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 20, 2026