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Clinical trial study on the improvement of symptoms in children and adolescents with mood disorders by emotional probiotics

Clinical trial study on the improvement of symptoms in children and adolescents with mood disorders by emotional probiotics

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125687
Enrollment
Unknown
Registered
2026-05-29
Start date
2026-06-01
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

Mood (Affective) Disorders

Interventions

Conventional treatment group:Conventional treatment
Research Group 2:Conventional treatment +Mood Probiotics (Metabotropic)
Research Group 1:Conventional Treatment+Mood Probiotics (Mood Sleep)

Sponsors

The Third Affiliated Hospital Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Patients who meet the diagnostic criteria for mood disorders; 2. There is no gender restriction, with an age range of 10-18 years old; 3. In the acute phase of disease onset, HAMD score >= 17 points; 4. No previous use of chlorpromazine treatment; 5. Able to communicate effectively with researchers and research staff, fill out research related materials, understand informed consent forms, and obtain informed consent from subjects/family members/guardians/legal representatives.

Exclusion criteria

Exclusion criteria: 1.Within the two weeks prior to admission, there was an infection or autoimmune disease present; 2. Abnormal white blood cell count and significant liver and kidney function in blood routine; 3. Individuals with severe physical illnesses and neurological disorders; 4. History of peptic ulcer and gastrointestinal bleeding; 5. Pregnant and lactating patients; 6. There are contraindications for drug use.

Design outcomes

Primary

MeasureTime frame
Changes in gut microbiota composition and structure relative to baseline after 12 weeks of combined use of emotional probiotics;Changes in serum inflammatory factors relative to baseline after 12 weeks of intervention with emotional probiotics;After 12 weeks of combined use of emotional probiotics, the changes in patients' anxiety and depression scale scores relative to baseline;

Secondary

MeasureTime frame
After 12 weeks of combined use of emotional probiotics intervention, changes in patients' weight, BMI, waist circumference, hip circumference, waist-to-hip ratio, body fat and liver fat content, blood pressure, and basal metabolic rate relative to baseline;

Countries

China

Contacts

Public ContactWu Xiaoli

The Third Affiliated Hospital Sun Yat-sen University

wuxiaoli@mail.sysu.edu.cn+86 20 8525 3333

Outcome results

None listed

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