Effectiveness and Safety of Probiotics in Relieving Anxiety and Depression

Inclusion criteria

• Voluntary, Written, and Signed Informed Consent: Agreeing to participate in the study.
• Ability to Complete the Study According to Protocol: Able to meet the requirements of the study protocol.
• Age: 18-65 years old.
• Depression and Anxiety Scores:

• Hamilton Depression Rating Scale (HAMD-17) score of 20 or higher, or
• Hamilton Anxiety Rating Scale (HAMA) score of 14 or higher.
• No History of Certain Conditions: No history of heart, liver, kidney, nervous system, psychiatric disorders, or metabolic abnormalities.

Exclusion criteria

• Past Diagnosis of Certain Conditions: Individuals with a history of other clearly diagnosed psychiatric disorders, intellectual disabilities, consciousness disorders, complete aphasia, bipolar disorder, treatment-resistant depression, or suicidal thoughts.
• Pregnant or Breastfeeding Women: Individuals who are pregnant or breastfeeding.
• Use of Certain Medications: Individuals who have used anti-anxiety, anti-depressant medications, or mood stabilizers within the past month.
• Allergy History: Individuals with allergic constitutions or a history of drug allergies, or those with severe systemic diseases.
• Substance Abuse History: Individuals with a history of alcohol or psychoactive substance abuse within the past 3 months.
• Impact of Medications on Gut Microbiota: Individuals who have used medications affecting gut microbiota (including antibiotics, probiotics, mucosal protectors, traditional Chinese medicine, etc.) continuously for more than 1 week in the month prior to screening.
• Discontinuation or Addition of Medications: Individuals who have stopped taking the study medication or started taking other medications, making it difficult to assess efficacy or with incomplete data.
• Use of Similar Products: Individuals who have taken items similar to the study product in the short term, affecting the evaluation of results.
• Inability to Participate: Research participants who cannot participate in the study due to personal reasons.
• Other Exclusions: Participants deemed unsuitable for the study by the researchers.