Skip to content

A double-blind controlled study of combined probiotics in the treatment of depression

A double-blind controlled study of combined probiotics in the treatment of depression

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124791
Enrollment
Unknown
Registered
2026-05-18
Start date
2024-02-28
Completion date
Unknown
Last updated
2026-05-25

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

Conditions

Depression

Interventions

Treatment group:Antidepressant drugs combined with probiotics for treatment
Control group:Antidepressant drugs plus placebo treatment

Sponsors

Huzhou Third People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with depression by ICD-10 criteria by two or more attending physicians; 2. Age 18-60 years old; 3. I or his agent sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Combined with malignant tumor; 2. The patient has a history of use of antibiotics, hormones, or intestinal microbiotics within 3 months before admission; 3. Patients with severe diarrhea or constipation; 4. Abuse of psychoactive substances; 5. Acute or chronic diseases (including stroke, epilepsy, high blood pressure, endocrine disease, diabetes, fatty liver disease or severe cardiovascular disease); 6. Co-existing neurological or physical diseases confirmed by detailed medical examination, in particular neurological examination, routine blood tests and computed tomography of the brain (if necessary); 7. A specific diet, such as a weight loss diet or one based entirely on vegetables; 8. Specific treatment within 6 months, such as transcranial magnetic stimulation or electroconvulsive therapy; 9. Pregnancy, breastfeeding; 10. There are obvious abnormalities in physical examination, neurological examination or blood routine.

Design outcomes

Primary

MeasureTime frame
Hamilton's Depression Scale(HAMD);

Secondary

MeasureTime frame
Psychosomatic Symptom Scale (PSSS);Patient Health Questionnaire -9 Items (PHQ-9);TESS Scale;Sequencing of intestinal microbial genes;Cytokines such as interleukins, interferons, and tumor necrosis factors;

Countries

China

Contacts

Public ContactShen zhongxia

Huzhou Third People's Hospital

zxm11982012@sina.com+86 137 5727 5095

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026