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due to its evolution, evaluation, as well as other reasons shared and reviewed between the parties
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Pregnants will take 1 capsule with a combination of probiotics (no comercial) daily from the 32nd week gestation to the 4th week postpartum (approximately 12 weeks). |
|
| Control group | Placebo Comparator | Pregnants will take 1 capsule with maltodextrin daily from the 32nd week gestation to the 4th week postpartum (approximately 12 weeks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination of Lactobacillus probiotics (no comercial) | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Postpartum Depression | 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 ā„12) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in EPDS | Analysis of different scores on the scale EPDS | 12 weeks |
| Incidence of anxiety | State-trait Anxiety Inventory (STAI-S) (score ā„40) |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant who is between 28-32 weeks of gestation.
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| Name | Affiliation | Role |
|---|---|---|
| Ruth Blanco Rojo, PhD | Biosearch S.A. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario del Sureste (Arganda del Rey, Madrid) | Arganda | Madrid | 28500 | Spain | ||
| ClĆnica Luna de BrigantĆa (Vigo, Pontevedra) |
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| D003863 | Depression |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Placebo | Dietary Supplement | 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 |
|
| 12 weeks |
| Changes in STAI-S | Analysis of different scores on the scale STAI-S | 12 weeks |
| Assessment of pain during breastfeeding | McGill Pain Questionnaire adapted to breastfeeding | 12 weeks |
| Cortisol in breast milk | 2 samples (at week 1 postpartum and week 4 postpartum) | 12 weeks |
| Cortisol in saliva | 3 samples (at the beginning of the study, at week 38 of gestation and at week 4 postpartum) | 12 weeks |
| Microbiota in breast milk | 2 samples (at week 1 postpartum and week 4 postpartum) | 12 weeks |
| Microbiota in mother's feces | 2 samples (at the beginning of the study and at week 38 of gestation) | 12 weeks |
| Comfort with breastfeeding | Survey on breastfeeding | 12 weeks |
| Vigo |
| Pontevedra |
| 36204 |
| Spain |
| Centro de Salud VillacaƱas de Toledo | VillacaƱas | Toledo | 45860 | Spain |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |