Improvement of post-partum depression and mastitis in healthy new mothers and reduction of excessive crying in the newborns. Mental and Behavioural Disorders
Conditions
Interventions
2 groups of 100 subjects were invited to orally take one capsule/day for 90 days, starting from delivery, as follows: one group (A) used the complete active treatment (Probiotics mix + multivitamin fo
Sponsors
Roelmi HPC
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Healthy pregnant female subjects after their delivery
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression and anxiety symptoms and post-natal stress measured using the Edinburgh Postnatal Depression Scale (EPDS) after 45 and 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Baby's crying, measured using Breastfeeding Self Efficacy Scale Short Form and Children Cry Questionnaires after 45 and 90 days. 2. Mastitis measured using Breastfeeding Quality Questionnaire after 45 and 90 days | — |
Countries
Italy
Outcome results
None listed