Effect of Consuming a Combination of Probiotic Strains on Postpartum Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postpartum Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental group

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).

Group Type EXPERIMENTAL

Combination of Lactobacillus probiotics (no comercial)

Intervention Type 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

Control group

Pregnants will take 1 capsule with maltodextrin daily from the 32nd week gestation to the 4th week postpartum (approximately 12 weeks).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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

Interventions

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Combination 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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes