Identification of Biomarkers of Mastitis

September 1, 2021 updated by: Paola Quifer Rada, LactApp Women's Health

Identification of Predictive Biomarkers of Mastitis in Lactating Mothers Using a Metabolomic Approach

Breastfeeding is the optimal feeding for infants. WHO currently promotes breastfeeding and recommends it to be exclusive until the baby is 6 months old. Breastfeeding has a positive impact on both the mother's and the infant's health and is directly associated with the decrease in diseases such as cancer, diabetes, cardiovascular disease, and inflammatory and infectious diseases. Currently, in Spain, only 39% of infants at 6 months are breastfed. The factors that influence the abandonment of breastfeeding are returning to work, the sensation of hypogalactia, problems to breastfeed, and breast complications, like mastitis, being the pain its main cause. Recent studies have associated pain while breastfeeding with mammary gland inflammation (mastitis) caused by dysbiosis.

In order to increase breastfeeding rates, it is necessary to find factors related to the progression of mastitis in breastfeeding women. In this context, the discovery of predictive biomarkers based on metabolic markers is key to act before or at the beginning of the progression of mastitis and thus reduce the rates of abandonment of breastfeeding due to pain.

The present project aims to identify and validate metabolic biomarkers capable of predicting mastitis. For this purpose, a prospective observational case-control hypothesis-free study will be carried out in order to identify and validate biomarkers of mastitis in breastfeeding women. The study will be performed in two phases: the discovery of the possible biomarkers and the validation of the biomarkers.

Breast milk will be collected at the beginning of the study and when women present symptoms compatible with mastitis. The presence or not of mastitis will be confirmed with a milk culture. Milk samples will be analyzed using non-targeted metabolomics approach. Using multivariate statistical models, the potential metabolites capable of discriminating the presence of mastitis in maternal milk will be identified. Later, these potential markers will be validated in independent samples.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08028
        • Recruiting
        • LactApp Clinic
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Alba Padró-Arocas
        • Principal Investigator:
          • Paola Quifer-Rada, PhD
        • Sub-Investigator:
          • Laia Aguilar-Camprubí
        • Sub-Investigator:
          • Desirée Mena-Tudela, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Lactating women will be included in the study. Women with the presence of acute mastitis, subacute mastitis, and with absence of symptomatology compatible with mastitis will be recruited as control samples.

Description

Inclusion Criteria:

  • Breastfeeding women with healthy full-term, singleton infants older than 1 months weeks and younger than 6 months.
  • Provide written informed consent

Exclusion Criteria:

  • Immunocompromised suppressed women (i.e. HIV, following treatment with immunosuppressants or chemotherapy).
  • Currently being treated for cancer
  • Current infection being treated with antibiotics.
  • Women who carry out a complete deferred breastfeeding.
  • Women with babies presenting any syndrome, cleft lip or facial malformations.
  • Currently tandem breastfeeding.
  • Women who have had a premature delivery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Acute mastitis (MA)
Lactating women with confirmed acute mastitis
Subacute mastitis (SAM)
Lactating women with confirmed subacute mastitis
Control (CT)
Lactating women with the absence of acute or subacute mastitis symptomatology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breast milk metabolites
Time Frame: 6 months
Breast milk Metabolite will be identified by NMR metabolomic analysis. Analytes will be quantified in mg/mL
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LactApp Women's Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Anticipated)

September 30, 2022

Study Completion (Anticipated)

April 30, 2023

Study Registration Dates

First Submitted

August 11, 2021

First Submitted That Met QC Criteria

August 24, 2021

First Posted (Actual)

August 25, 2021

Study Record Updates

Last Update Posted (Actual)

September 9, 2021

Last Update Submitted That Met QC Criteria

September 1, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LactApp001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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