An observational study in Breast Feeding, Mastitis and Mastitis Acute Female, sponsored by LactApp Women's Health. Status unknown at 1 site in Spain. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2021-09-09.
Sponsored by LactApp Women's Health · Observational
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.
1,081 studies on the registry are indexed under Breast Feeding; 217 are open to participants now.
This study's planned enrollment of 150 is close to the median of 158 across 207 observational studies indexed under Breast Feeding.
Browse Breast Feeding studies →This is the only study on the registry with LactApp Women's Health as lead sponsor.
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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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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The human immunodeficiency virus, which weakens the immune system.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lactating women with confirmed acute mastitis
Lactating women with confirmed subacute mastitis
Lactating women with the absence of acute or subacute mastitis symptomatology.
Breast milk metabolites
Breast milk Metabolite will be identified by NMR metabolomic analysis. Analytes will be quantified in mg/mL
Time frame: 6 months
Plan to share: Undecided
Started May 2021 (actual). Primary completion is estimated for Sep 2022, 16 months after the start.
Of 96 observational studies under Breast Feeding, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 73. This study's planned 16 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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