NCT06651424

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

October 21, 2024

Completed
Last Updated

October 21, 2024

Status Verified

October 1, 2024

Enrollment Period

1 year

First QC Date

August 24, 2022

Last Update Submit

October 18, 2024

Conditions

Postpartum Depression

Keywords

ProbioticsDepressionPostpartum

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Changes in EPDS

    12 weeks

  • Incidence of anxiety

    12 weeks

  • Changes in STAI-S

    12 weeks

  • Assessment of pain during breastfeeding

    12 weeks

  • Cortisol in breast milk

    12 weeks

  • +4 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

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)

Control group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Combination of Lactobacillus probiotics (no comercial)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

Experimental group
PlaceboDIETARY_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

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant who is between 28-32 weeks of gestation.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Universitario del Sureste (Arganda del Rey, Madrid)

Arganda, Madrid, 28500, Spain

Location

Clínica Luna de Brigantía (Vigo, Pontevedra)

Vigo, Pontevedra, 36204, Spain

Location

Centro de Salud Villacañas de Toledo

Villacañas, Toledo, 45860, Spain

Location

MeSH Terms

Conditions

Depression, PostpartumDepression

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Ruth Blanco Rojo, PhD

    Biosearch S.A.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2022

First Posted

October 21, 2024

Study Start

July 1, 2022

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

October 21, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(3)