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Clinical efficacy and mechanism study of Saccharomyces boulardii in assisting the improvement of depression

Clinical efficacy and mechanism study of Saccharomyces boulardii in assisting the improvement of depression

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125737
Enrollment
Unknown
Registered
2026-05-29
Start date
2026-05-31
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

depression

Interventions

Experimental group:Antidepressant combined with Saccharomyces boulardii treatment

Sponsors

First Affiliated Hospital of Kunming Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1.Meets the diagnostic criteria for depression according to ICD-11, aged 18-55 years old; 2.No antidepressant medication has been taken in the past three months, and no probiotic preparations or antibiotics have been taken in the past month; 3.No significant organic disease; 4.Capable of cooperating in completing scale assessments and collecting blood and fecal specimens; 5.Voluntarily participate and sign the informed consent form; 6.Combined with gastrointestinal discomforts such as abdominal distension and diarrhea;

Exclusion criteria

Exclusion criteria: 1.Individuals with brain organic diseases or other mental and psychological disorders such as schizophrenia, bipolar disorder, or mania; 2.Individuals with intestinal diseases such as peptic ulcer, inflammatory bowel disease, or colorectal cancer, or those who have undergone gastrointestinal surgery within the past 6 months; 3.Women who are in gestation period, within one year after childbirth, or in lactation period; 4.Malignant tumor, undergoing radiotherapy and chemotherapy, or history of other severe diseases; 5.Individuals with severe cognitive dysfunction who are unable to complete scale assessments and related tests; 6.Individuals with lactose intolerance, as well as those allergic to milk protein and yeast;

Design outcomes

Primary

MeasureTime frame
anxiety score;Depression score;

Secondary

MeasureTime frame
Short-chain fatty acids (SCFAs);sleep quality;Brain-derived neurotrophic factor(BDNF);cognitive function;Gut microbiota;inflammatory factors;social function;Overall clinical efficacy evaluation;side reaction;

Countries

China

Contacts

Public ContactLiu Fang

First Affiliated Hospital of Kunming Medical University

liufang6@kmmu.edu.cn+86 871 65324888

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026