Effect of Consuming a Combination of Probiotic Strains on Postpartum Depression

Biosearch S.A.5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Postpartum Depression

Interventions

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

PlaceboDIETARY_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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

Hospital Universitario del Sureste (Arganda del Rey, Madrid)

Arganda, Madrid, Spain

Clínica Luna de Brigantía (Vigo, Pontevedra)

Vigo, Pontevedra, Spain

Centro de Salud Villacañas de Toledo

Villacañas, Toledo, Spain

Outcomes

Primary Outcomes

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 ≥12)

Time frame: 12 weeks

Secondary Outcomes

Changes in EPDS

Analysis of different scores on the scale EPDS

Time frame: 12 weeks

Incidence of anxiety

State-trait Anxiety Inventory (STAI-S) (score ≥40)

Time frame: 12 weeks

Changes in STAI-S

Analysis of different scores on the scale STAI-S

Time frame: 12 weeks

Assessment of pain during breastfeeding

McGill Pain Questionnaire adapted to breastfeeding

Time frame: 12 weeks

Cortisol in breast milk

2 samples (at week 1 postpartum and week 4 postpartum)

Time frame: 12 weeks

Cortisol in saliva

3 samples (at the beginning of the study, at week 38 of gestation and at week 4 postpartum)

Time frame: 12 weeks

Microbiota in breast milk

2 samples (at week 1 postpartum and week 4 postpartum)

Time frame: 12 weeks

Microbiota in mother's feces

Data from ClinicalTrials.gov

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