Postpartum anxiety and depression
Conditions
Interventions
Experimental group:The participants are required to take Saccharomyces boulardii once daily, with 1 sachet per dose (i.e., 2×10^10 CFU/day), for a total of 12 weeks of intervention.
Administration met
or take it directly by mouth.
Control group:The control group will receive a placebo consisting of maltodextrin, which is similar to the Saccharomyces boulardii preparation taken by the intervention group in terms of dosage form,
alternatively, it may be taken orally directly.
Sponsors
Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The participants must meet all of the following criteria: 1.Agree to participate in the trial and sign the informed consent form. 2.Aged 18 years or older, in the late pregnancy stage (after 32 weeks of gestation). 3.EPDS score >= 11 and < 21. 4.No history of pre-pregnancy hypertension, diabetes, hyperlipidemia, hepatitis, nephritis, gastrointestinal diseases (such as chronic gastritis, enteritis, gastric ulcers, duodenal ulcers, etc.), infectious diseases (such as hepatitis, tuberculosis, etc.), or psychiatric disorders (such as depression, etc.). 5.Permanent resident of Wuhan.
Exclusion criteria
Exclusion criteria: Participants who meet any of the following criteria will be excluded from this trial: 1.Have taken probiotics or prebiotics for more than three days in the past month, or need to take any other live bacterial nutritional supplements (other than the intervention) during the intervention period. 2.Have a history of psychiatric disorders or have previously or are currently taking medications for mental health treatment. 3.Incomplete data. 4.Smoke more than 10 cigarettes per day or drink more than 2 liang (100g) of liquor daily (beer and wine converted to pure alcohol). 5.Cannot correctly answer questions due to mental health issues or are unwilling to complete the questionnaire survey. 6.Lactose intolerant or allergic to milk proteins. 7.Have participated in other clinical trials in the past three months. 8.Have received antibiotic treatment in the past 4 weeks or are about to receive antifungal treatment. 9.Allergic to Saccharomyces boulardii or placebo ingredients (maltodextrin). 10.Cannot be followed up daily by phone or internet, or have recent travel plans.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Gastrointestinal Symptom Rating Scale;Gut Microbiota Composition and Diversity;5-HT;TRP;IL-6;IL-10;TNF-a;INF-?;sIgA; | — |
Primary
| Measure | Time frame |
|---|---|
| Edinburgh Postnatal Depression Scale Score;State-Trait Anxiety Inventory Score;Pittsburgh Sleep Quality Index; | — |
Countries
China
Contacts
Public ContactYang Xuefeng
Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed