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A Preliminary Study on the Effect and Safety of Kaixinji Probiotic Powder on Improving Mood in Individuals with Depression and Anxiety

A Preliminary Study on the Effect and Safety of Kaixinji Probiotic Powder on Improving Mood in Individuals with Depression and Anxiety

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122363
Enrollment
Unknown
Registered
2026-04-13
Start date
2026-04-13
Completion date
Unknown
Last updated
2026-04-20

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

Conditions

Moderate to mild depression, moderate to mild anxiety

Interventions

Control Group:placebo
Experimental Group:Happy Season Probiotic Powder

Sponsors

Wuxi No.2 People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Age 18-70 years old; 2.The Self-Rating Anxiety Scale (SAS) score is 50-69 points (mild to moderate anxiety), and the Self-Rating Depression Scale (SDS) score is 53-62 points (mild to moderate depression). 3.Have not taken probiotic preparations, anti-anxiety/antidepressant drugs, or sedative-hypnotic drugs in the past month; have not used antibiotics, glucocorticoids, or other drugs that affect intestinal flora in the past 2 weeks; have a regular daily diet, and have no habit of long-term consumption of fermented foods (yoghurt, kimchi, natto, etc.); 4.He reported no gastrointestinal ulcers, inflammatory bowel disease, low immune function and other diseases; no history of serious mental illness such as schizophrenia and bipolar disorder; no chronic underlying diseases such as liver and kidney insufficiency, cardiovascular and cerebrovascular diseases. 5.Voluntarily sign the informed consent form, understand and commit to abide by all research procedures (including taking trial products on time, completing interviews, recording logs, etc.);

Exclusion criteria

Exclusion criteria: 1.People allergic to probiotic strains and placebo ingredients; 2.Women who are pregnant, lactating, or planning to become pregnant during the trial; 3.Those who have participated in other clinical trials in the past 3 months, or are receiving psychotherapy or cognitive behavioral intervention; 4.Those with a history of alcohol, tobacco or drug dependence, or long-term drinking of strong tea and coffee (=3 cups a day); 5.Those who are unable to cooperate in completing the questionnaire, recording medication, or cannot be contacted during the follow-up period;

Design outcomes

Primary

MeasureTime frame
Depressive state;anxious state;

Secondary

MeasureTime frame
Blood routine test, liver and kidney function tests;

Countries

China

Contacts

Public ContactCao pei

Wuxi No.2 People’s Hospital

1278051417@qq.com+86 510 68562651

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026