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Clinical Evaluation of Probiotics' Effect on Mood Disorder and Gastrointestinal Dysfunction

Analysis and intervention of intestinal flora for mood disorders and concomitant gastrointestinal dysfunction

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069487
Enrollment
Unknown
Registered
2023-03-19
Start date
2023-03-20
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Mood disorder

Interventions

Bifidobacterium longum CCFM687 group:Consume 2 packages of probiotics daily (viable count >= 10^9CFU/ day)
Pediococcus acidilactici CCFM6432 group:Consume 2 packages of probiotics daily (viable count >= 10^9CFU/ day)
Lactobacillus reuteri CCFM1288 group:Consume 2 packages of probiotics daily (viable count >= 10^9CFU/ day)

Sponsors

Wuxi Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Clinical diagnosis of depressive disorder or anxiety disorder; 2. Meet the hospital anxiety and depression scale (HADS) score >= 11; 3. Aged >= 18 years; 4. Primary school education level or above, no speech expression barrier.

Exclusion criteria

Exclusion criteria: 1. Refractory depression; 2. Conform to DSM-IV Axis I diagnosis of other mental diseases; 3. Suicide and self injury; 4. Patients with schizophrenia, bipolar disorder and neurodegenerative diseases; 5. Serious physical diseases, such as HIV, history of epilepsy, history of heart, hyperthyroidism and other serious physical diseases; 6. Pregnant or breast-feeding women; 7. Male or female during pregnancy (childbirth); 8. Have used antibiotics, probiotics and their products in the past month; 9. Unwilling to accept clinical trials.

Design outcomes

Primary

MeasureTime frame
Hospital Anxiety and Depression Scale;Self-Rating Anxiety Scale;

Secondary

MeasureTime frame
Fecal microbiota analysis;Serological indicators;Gastrointestinal Symptom Rating Scale-self;Pitts? urgh Sleep Quality Index;

Countries

China

Contacts

Public ContactJun Wang

Wuxi Mental Health Center

pjtian@jiangnan.edu.cn+86 18816201266

Outcome results

None listed

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