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Efficacy evaluation and mechanism exploration of multi-probiotic in the adjuvant treatment of adult anxiety and depression

Efficacy evaluation and mechanism exploration of multi-probiotic in the adjuvant treatment of adult anxiety and depression

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076769
Enrollment
Unknown
Registered
2023-10-18
Start date
2023-11-01
Completion date
Unknown
Last updated
2023-10-22

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

Conditions

Depression

Interventions

Probiotics:Lactobacillus plantarum GL-5, Lactobacillus plantarum LZU-J-TSL 6, and maltodextrin
Placebo:Maltodextrin

Sponsors

School of life science, Lanzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with depression aged between 18 and 65 years, and with no serious adverse reactions to commonly used antidepressants (included according to the DSM-V diagnostic criteria and the actual diagnostic advice of clinicians).

Exclusion criteria

Exclusion criteria: 1.Patients with treatment-resistant depression 2.Female patients currently in pregnancy and lactation 3.Depressive patients with severe self-harm or suicidal tendencies 4.Patients with serious physical illness (including but not limited to patients with malignant tumors and infectious diseases) 5.Patients with other mental disorders, such as schizophrenia, bipolar disorder, and neurodegenerative diseases 6.Other specific populations considered unsuitable for inclusion in this study (e. g. patients with abnormal thyroid function)

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Rating Scale;Hamilton Anxiety Rating Scale;Gastrointestinal Symptom Rating Scale;Self-rating depression scale;Self-rating anxiety scale;Athens insomnia scale;Pittsburgh sleep quality index;

Secondary

MeasureTime frame
Serum IL-1ß;Serum IL-6;Serum TNF-a;Serum cortisol;Serum 5-HT;Serum 5-HTP;Serum GABA;Serum LPS;Serum Zonulin;Serum I-FABP;Serum Claudin-5;Fecal microbial analysis;Serum metabolomics;

Countries

China

Contacts

Public ContactZhang Chunjiang

Lanzhou University

chjzh@lzu.edu.cn+86 138 9312 8525

Outcome results

None listed

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