NCT04032899

Brief Summary

The aim of the present study is to evaluate the effect of consumption during pregnancy and the lactation period of the probiotic L. fermentum CECT5716 on the incidence of mastitis. Bacterial load and immunological parameters in breast milk, parameters related to breastfeeding as well as health parameters of the mother and baby will also be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
480

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 27, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 25, 2019

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

February 6, 2025

Status Verified

February 1, 2025

Enrollment Period

5.1 years

First QC Date

May 27, 2019

Last Update Submit

February 4, 2025

Conditions

MastitisBreast MilkLactationWomen's HealthInfant Health

Keywords

ProbioticsGestationLactationMastitis

Outcome Measures

Primary Outcomes (1)

  • Incidence of mastitis

    Total events during breastfeeding period /total number of participants

    4 months

Secondary Outcomes (1)

  • Microbiota of breast milk

    4 months

Other Outcomes (12)

  • Recurrence of mastitis

    4 months

  • Breast pain questionnaire

    4 months

  • Time of Breastfeeding

    4 months

  • +9 more other outcomes

Study Arms (2)

L. fermentum CECT5716 3x109 ufc

EXPERIMENTAL

Volunteers will take 1 capsule per day with L. fermentum CECT5716 3x109 cfu mixed with maltodextrin from week 28-32 of gestation up to 16 weeks after delivery.

Dietary Supplement: Lactobacillus fermentum CECT5716

Maltodextrin

PLACEBO COMPARATOR

Volunteers will take 1 capsule per day with maltodextrin from week 28-32 of gestation up to 16 weeks after delivery.

Dietary Supplement: Maltodextrin

Interventions

Lactobacillus fermentum CECT5716DIETARY_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.

L. fermentum CECT5716 3x109 ufc
MaltodextrinDIETARY_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.

Maltodextrin

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal development of pregnancy
  • Single fetus pregnancy
  • Be in week 28-32 of pregnancy
  • Intention to breastfeed the child for 16 weeks

You may not qualify if:

  • Having a breast disease that hinders or prevents breastfeeding
  • Have been taking probiotic supplements 2 weeks before starting the study
  • Have a low expectation of adherence to the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Costa del Sol

Marbella, Andalusia, 29603, Spain

Location

Hospital Campus de la Salud

Granada, Grabada, 18007, Spain

Location

Hospital Virgen de las Nieves

Granada, Granada, 18014, Spain

Location

Related Publications (1)

  • Crepinsek MA, Taylor EA, Michener K, Stewart F. Interventions for preventing mastitis after childbirth. Cochrane Database Syst Rev. 2020 Sep 29;9(9):CD007239. doi: 10.1002/14651858.CD007239.pub4.

    PMID: 32987448DERIVED

MeSH Terms

Conditions

MastitisBreast Feeding

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesFeeding BehaviorBehavior

Study Officials

  • Nicolás Mendoza, MD, PhD

    Professor of Gynecology at the Faculty of Medicine of the University of Granada

    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

May 27, 2019

First Posted

July 25, 2019

Study Start

April 15, 2019

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

February 6, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(3)