Breast FeedingNCT05021042
Identification of Biomarkers of Mastitis
An observational study of Breast Feeding and Mastitis, run by LactApp Women's Health at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Breast Feeding, Mastitis, Mastitis Acute Female
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2021to 30 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Adult
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.
Who may be able to join
- Breastfeeding women with healthy full-term, singleton infants older than 1 months weeks and younger than 6 months.
- Provide written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
LactApp Clinic
Barcelona, 08028
Paola Quifer-Rada, PhD, paola@lactapp.es
Laia Aguilar-Camprubí, laia@lactapp.es
About this study
Official title: 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.
Read more
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.
- Conditions
- Breast Feeding, Mastitis, Mastitis Acute Female
- Keywords
- breastfeeding, breast milk, mastitis, acute mastitis, subacute mastitis, biomarkers
- Medical subject headings
- Breast Feeding, Mastitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Breast milk metabolites
Breast milk Metabolite will be identified by NMR metabolomic analysis. Analytes will be quantified in mg/mL
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start1 May 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LactApp Women's Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Paola Quifer Rada, LactApp Women's Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021042
- Sponsor's protocol ID
- LactApp001
- Status last verified
- Sep 2021
- First submitted
- 11 Aug 2021
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Predictive Biomarkers of Mastitis in Lactating Mothers Using a Metabolomic Approach
- ClinicalTrials.gov ID
- NCT05021042
- Acronym / sponsor ID
- LactApp001
- Conditions
- Breast Feeding, Mastitis, Mastitis Acute Female
- Keywords
- breastfeeding, breast milk, mastitis, acute mastitis, subacute mastitis, biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- LactApp Women's HealthIndustry (pharma, biotech, devices)
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Breastfeeding women with healthy full-term, singleton infants older than 1 months weeks and younger than 6 months.
- Provide written informed consent
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Breast milk metabolites
Time frame: 6 months
Breast milk Metabolite will be identified by NMR metabolomic analysis. Analytes will be quantified in mg/mL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Feeding and Mastitis, run by LactApp Women's Health at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast milk metabolites (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.