A randomized double blind controlled clinical study to assess the effect of treatment with a probiotic supplement targeted to women after pregnancy, to reduce postpartum symptoms of depression and anxiety

Roelmi HPC0 sites200 target enrollmentNovember 24, 2021

Overview

Phase: 未知
Intervention: Not specified
Conditions: Improvement of post-partum depression and mastitis in healthy new mothers and reduction of excessive crying in the newborns.
Sponsor: Roelmi HPC
Enrollment: 200
Status: Completed
Last Updated: 2 years ago

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37630704/ (added 17/01/2024)

Registry

who.int

Start Date

November 24, 2021

End Date

July 26, 2021

Last Updated

2 years ago

Study Type

Interventional

Sex

Female

Sponsor

Roelmi HPC

•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