Postpartum Depression
Conditions
Keywords
Probiotics, Depression, Postpartum
Brief summary
The objective of this trial is to evaluate the effect of consuming a combination of Lactobacillus during the pregnancy and lactation period on the incidence of postpartum depression.
Detailed description
The mood disorders such as postpartum depression have a very high incidence. There is a relationship between a woman's microbiota and the risk of postpartum depression. The possibility of influencing the microbiota through probiotic treatments opens a door to the prevention and/or treatment of postpartum depression. Therefore, the objective of this trial is to evaluate the effect of consuming a combination of Lactobacillus during the pregnancy and lactation period on the incidence of postpartum depression.
Interventions
DIETARY_SUPPLEMENTCombination of Lactobacillus probiotics (no comercial)
Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits
DIETARY_SUPPLEMENTPlacebo
Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits
Sponsors
Biosearch S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant who is between 28-32 weeks of gestation. * Normal development of pregnancy. * Singleton pregnancy. * Score ≥12 scale Postpartum depression questionnaire Edinburgh. * Pregnant who has the firm intention of breastfeeding her child for at least the first month. * Sign the Informed Consent.
Exclusion criteria
* Have any breast pathology that makes it difficult or impossible to breastfeed. * Consume other probiotic supplements during the study. * History of serious mental disorders other than affective disorders, whether or not currently under pharmacological treatment. * Low expectation of adherence to the study protocol. * Pharmacological treatment incompatible with the study. * Non-compliance with the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postpartum Depression | 12 weeks | Edinburgh Postnatal Depression Scale (EPDS) (Score min=0; Max=30; The woman will be considered to have PPD if the Edinburgh Survey Scale score is ≥12) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of anxiety | 12 weeks | State-trait Anxiety Inventory (STAI-S) (score ≥40) |
| Changes in STAI-S | 12 weeks | Analysis of different scores on the scale STAI-S |
| Assessment of pain during breastfeeding | 12 weeks | McGill Pain Questionnaire adapted to breastfeeding |
| Cortisol in breast milk | 12 weeks | 2 samples (at week 1 postpartum and week 4 postpartum) |
| Changes in EPDS | 12 weeks | Analysis of different scores on the scale EPDS |
| Microbiota in breast milk | 12 weeks | 2 samples (at week 1 postpartum and week 4 postpartum) |
| Microbiota in mother's feces | 12 weeks | 2 samples (at the beginning of the study and at week 38 of gestation) |
| Comfort with breastfeeding | 12 weeks | Survey on breastfeeding |
| Cortisol in saliva | 12 weeks | 3 samples (at the beginning of the study, at week 38 of gestation and at week 4 postpartum) |
Countries
Spain
Outcome results
None listed