Clinical trial NCT06651424: Effect of Consuming a Combination of Probiotic Strains on Postpartum Depression
Official title: Multicenter, Randomized, Double-blind, Parallel-group Controlled Nutritional Intervention Study to Evaluate the Effect of a Combination of Probiotic Strain on Postpartum Depression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Postpartum Depression
Keywords: Probiotics
Depression
Postpartum
Lead sponsor: Biosearch S.A.
Sponsor class: INDUSTRY
First posted: 2024-10-21
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Postpartum Depression
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in EPDS
timeFrame: 12 weeks
measure: Incidence of anxiety
timeFrame: 12 weeks
measure: Changes in STAI-S
timeFrame: 12 weeks
measure: Assessment of pain during breastfeeding
timeFrame: 12 weeks
measure: Cortisol in breast milk
timeFrame: 12 weeks
measure: Cortisol in saliva
timeFrame: 12 weeks
measure: Microbiota in breast milk
timeFrame: 12 weeks
measure: Microbiota in mother's feces
timeFrame: 12 weeks
measure: Comfort with breastfeeding
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Arganda Del Rey
country: Spain
facility: Hospital Universitario del Sureste (Arganda del Rey, Madrid)
state: Madrid
city: Vigo
country: Spain
facility: Clínica Luna de Brigantía (Vigo, Pontevedra)
state: Pontevedra
city: Villacañas
country: Spain
facility: Centro de Salud Villacañas de Toledo
state: Toledo
Study officials:
affiliation: Biosearch S.A.
name: Ruth Blanco Rojo, PhD
role: PRINCIPAL_INVESTIGATOR
References: