A clinical study to assess the efficacy of a probiotic supplement for women to reduce depression and anxiety symptoms after giving birth
- Conditions
- Improvement of post-partum depression and mastitis in healthy new mothers and reduction of excessive crying in the newborns.Mental and Behavioural Disorders
- Registration Number
- ISRCTN99047904
- Lead Sponsor
- Roelmi HPC
- Brief Summary
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37630704/ (added 17/01/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 200
Healthy pregnant female subjects after their delivery
1. Subjects who do not meet the inclusion criteria
2. Subjects considered as not adequate to participate to the study by the investigator
3. Subjects with known or suspected sensitization to one or more test formulation ingredients
4. Adult protected by law (under control or hospitalized in public or private institutions for reasons other than research, or incarcerated)
5. Subjects not able to communicate or cooperate with the investigator for problems related to language, mental retardation or impaired brain function
6. Suffering from other psychiatric disorders such as schizophrenia, other psychotic disorders, bipolar disorder or substance use disorder
7. Serious physical illnesses or mental disorders due to a general medical condition which are judged by the investigator to render unsafe
8. A significant risk of infanticide according to the investigator assessment
9. Herbal remedies or psychotropic drugs that are intended for depression are taken within the last 2 weeks prior to baseline or during the study
10. Receiving counseling or psychological therapies at baseline or during the study
11. Participation in any clinical trial within the previous 3 months prior to baseline
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method