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Study for effect of probiotics on depressive symptoms and its inflammatory mechanism

Study for effect of probiotics on depressive symptoms and its inflammatory mechanism

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025175
Enrollment
Unknown
Registered
2019-08-15
Start date
2019-08-01
Completion date
Unknown
Last updated
2019-08-27

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

Conditions

Depressive disorder

Interventions

probiotics:clostridium tyrosinate
fluoxetine:fluoxetine
combination therapy:clostridium tyrosinate+fluoxetine

Sponsors

The First Hospital of Shanxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: (1) Subjects must meet the diagnostic criteria of depressive disorder for DSM-IV and been confirmed by the international neuropsychiatric brief interview questionnaire (MINI); (2) Untreated first episode; (3) Subjects were aged between 18 and 55 years; (4) The total score of HAMD scale (24 items) cann't lesser than 20 points; (5) Subjects voluntarily participate this study and sign the written informed consent.

Exclusion criteria

Exclusion criteria: (1) Subjects are suffering from other mental illness; (2) Subjects are suffering from other physical diseases, especially gastrointestinal diseases (requiring medication); (3) Subjects have serious suicidal tendencies and history of alcohol or other substance dependence abuse; (4) Subjects have family history of bipolar disorder, schizophrenia and other mental diseases; (5) Subjects received antibiotics and probiotics within the last 1 month; (6) Subjects are pregnant or lactating; (7) Subjects have participated in one clinical trial in the past 90 days or two or more clinical trials in the past year.

Design outcomes

Primary

MeasureTime frame
immune index;metabolic index;Intestinal flora abundance and diversity;intestinal mucosal barrier;Clinical symptom;

Secondary

MeasureTime frame
MRI of brain;

Countries

China

Contacts

Public ContactPenghong Liu

The First Hospital of Shanxi Medical University

liupenghong6@163.com+86 18834180209

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026