Effect of Consuming a Combination of Probiotic Strains on Postpartum Depression

Multicenter, Randomized, Double-blind, Parallel-group Controlled Nutritional Intervention Study to Evaluate the Effect of a Combination of Probiotic Strain on Postpartum Depression

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 Overview

• Status: Terminated
• Conditions: Postpartum Depression
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Combination of Lactobacillus probiotics (no comercial)

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Arganda Del Rey, Madrid, Spain, 28500
      • Hospital Universitario del Sureste (Arganda del Rey, Madrid)
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36204
      • Clínica Luna de Brigantía (Vigo, Pontevedra)
  • Toledo
    • Villacañas, Toledo, Spain, 45860
      • Centro de Salud Villacañas de Toledo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Dietary supplement: 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
Placebo Comparator: Control group; Pregnants will take 1 capsule with maltodextrin daily from the 32nd week gestation to the 4th week postpartum (approximately 12 weeks).	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Biosearch S.A.
• Investigators: Principal Investigator: Ruth Blanco Rojo, PhD, Biosearch S.A.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: October 18, 2024
• First Posted (Actual): October 21, 2024

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Depression; Probiotics; Postpartum
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: P060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No