Effect of Consuming a Combination of Probiotic Strains on Postpartum Depression

Not Applicable

Terminated

• Conditions: Postpartum Depression

• Registration Number: NCT06651424
• Lead Sponsor: Biosearch S.A.

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.

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-08-24
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-18
• Last Update Submitted: 2024-10-18
• Study First Posted: 2024-10-21
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of Postpartum Depression	12 weeks	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)

Secondary Outcome Measures

Name	Time	Method
Changes in EPDS	12 weeks	Analysis of different scores on the scale EPDS
Incidence of anxiety	12 weeks	State-trait Anxiety Inventory (STAI-S) (score ≥40)
Changes in STAI-S	12 weeks	Analysis of different scores on the scale STAI-S
Assessment of pain during breastfeeding	12 weeks	McGill Pain Questionnaire adapted to breastfeeding
Cortisol in breast milk	12 weeks	2 samples (at week 1 postpartum and week 4 postpartum)
Cortisol in saliva	12 weeks	3 samples (at the beginning of the study, at week 38 of gestation and at week 4 postpartum)
Microbiota in breast milk	12 weeks	2 samples (at week 1 postpartum and week 4 postpartum)
Microbiota in mother's feces	12 weeks	2 samples (at the beginning of the study and at week 38 of gestation)
Comfort with breastfeeding	12 weeks	Survey on breastfeeding

Trial Locations

Locations (3)

Clínica Luna de Brigantía (Vigo, Pontevedra); 🇪🇸 Vigo, Pontevedra, Spain

Centro de Salud Villacañas de Toledo; 🇪🇸 Villacañas, Toledo, Spain

Hospital Universitario del Sureste (Arganda del Rey, Madrid); 🇪🇸 Arganda Del Rey, Madrid, Spain