Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05021042
Study type Observational
Source LactApp Women's Health
Contact
Status Recruiting
Phase
Start date May 1, 2021
Completion date April 30, 2023

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04487418 - Evaluation of the Effects of High-level Laser and Electro-cautery in Lingual Frenotomy Surgeries in Infants N/A
Completed NCT03334266 - Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months N/A
Enrolling by invitation NCT02687685 - Clinical Trial of Immediate Skin to Skin Contact at Birth Early vs. Immediate (CPPITLH) N/A
Completed NCT02952950 - Is it Possible to Prolong the Duration of Breastfeeding in Premature Infants? a Prospectivt Study N/A
Completed NCT03033459 - Prenatal Lactation-Focused Motivational Interviewing N/A
Completed NCT02913638 - A Post Breastfeeding Follow-Up Study N/A
Not yet recruiting NCT05846828 - Cognitive Functions in Breastfed Preschool Children
Completed NCT05944471 - The Effect of Telehealth on Feeding Exclusive Breastfeeding in the Perception of Insufficient Milk N/A
Completed NCT05629403 - Exclusive Breastfeeding Improves Puerperal Glucose Metabolism in Pregnant Women With Gestational Diabetes Mellitus and Links to Lipids Composition
Completed NCT04024865 - Domperidone and Risk of Serious Cardiac Events in Postpartum Women
Recruiting NCT05560750 - Lingual Frenulum in Newborn Infants (LINNE) N/A
Completed NCT03232762 - Effects of Diet on Pregnancy Outcome and Child Obesity N/A
Recruiting NCT02186613 - Telephone Support From Primary Care for Breastfeeding Mothers N/A
Completed NCT01687634 - Home Visiting for Low Income, Pregnant Women N/A
Completed NCT01459991 - The Mediterranean Diet and Lactation Study: A Diet Study in Lactating Women N/A
Completed NCT03574766 - Meditation for NICU Moms N/A
Recruiting NCT03945474 - Osteopathic Manipulation in Breastfed Newborns N/A
Recruiting NCT06107933 - Developmental Impacts of Microplastics Exposure in Early Life
Not yet recruiting NCT05059574 - Breast Crawling,Breastfeeding Success and Mothers' Attitudes to Feeding Their Babies N/A
Completed NCT04578925 - Happy, Healthy, Loved: A Mobile-delivered Breastfeeding Self-efficacy Intervention for First Time Parents N/A