Effect of Consuming a Combination of Probiotic Strains on Postpartum Depression

Biosearch Life

Status: Terminated

Conditions: Postpartum Depression

Treatments: Dietary Supplement: Combination of Lactobacillus probiotics (no comercial); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06651424

P060

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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5 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Combination of Lactobacillus probiotics (no comercial)

Control group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo