Breast Milk CollectionNCT05943847
Neurotrophic Growth Factors in Breast Milk
An observational study of Breast Milk Collection, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to demonstrate the presence of neurotrophic factors in the breast milk of mothers with 18-month-old children and the persistence of these factors in breast milk after the age of 2 years. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Milk Collection
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Mar 2023to 1 Jun 2024
- How long will I take part?
- 12 Months
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: On the basis of the inclusion and exclusion criteria 25 mothers will be included in this study
Who may be able to join
- Mothers who applied for the 18th-month follow-up of their exclusively breastfed baby for the first 6 months agreed to participate in the study.
Who cannot join
- Mothers of infants who were not exclusively breastfed in the first six months
- Mothers with infection, metabolic disease, central nervous system, breast disease or pregnancy
- Mothers of infants with infection, metabolic disease, malnutrition and central nervous system disease
- Mothers who stop breastfeeding before 25 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İstanbul University İstanbul Medical Faculty Department of Pediatrics Division of Social Pediatrics
Istanbul
Gonca Keskindemirci, Assoc Prof, 0905324934651, keskindemirci@hotmail.com
Öykü Özbörü Aşkan, PhD, 0905333177407, oykuozboru@gmail.com
About this study
Official title: Evaluation of Neurotrophic Growth Factors in Breast Milk at Two Years of Age and Beyond
The goal of this observational study is to demonstrate the presence of neurotrophic factors in the breast milk of mothers with 18-month-old children and the persistence of these factors in breast milk after the age of 2 years. The main questions it aims to answer are:
- Does the breast milk of mothers with 18-month-old babies contain Brain-Derived Neurotrophic Factor (BDNF), S100B protein and glial cell line-derived neurotrophic factor (GDNF)?
- Does the breast milk continue to contain BDNF, s100B protein and GDNF and-after 24 months?
Participants will be asked to give breastmilk at 3 separate times. Breast milk samples will be collected from mothers at 18th-month, 24th-month and ≥25 months of their babies. A total of 75 breast milk samples obtained from 25 mothers with their consent will be analyzed.
Read the detailed description
Growth factors are among the bioactive compounds found in breast milk and have effects on the growth and maturation of the baby's organs and systems. The completion of each organ maturation occurs at different times. Although the development of the nervous system reaches 60% of adults at the age of 2 years, it continues after the age of 2. Brain-Derived Neurotrophic Factor (BDNF), S100B protein, and glial cell line-derived neurotrophic factor (GDNF) are the neurotrophic growth factors found in breast milk and play a critical role in the development of the nervous system, the maintenance of neuronal functionality and the proliferation of neurons . They play a role during brain development, particularly in differentiating neuronal and glial cells. In addition, it is effective in synaptic plasticity and has important roles in the mature nervous system. The presence of neurotrophic factors in breast milk under the age of one has been demonstrated. However, the presence of these factors in breast milk has not been evaluated at 2 years and above. In this study, investigators aimed to demonstrate the presence of neurotrophic factors in the breast milk of mothers with 18-month-old children and the persistence of these factors in breast milk after the age of 2 years.
Study Design:
The study was conducted at Istanbul University, Istanbul Medical Faculty, Department of Pediatrics, Department of Social Pediatrics, Well Child Outpatient Clinic. All mothers participating in the study are informed in detail about the study and the importance of breast milk. According to Turkish Demographic and Health Survey (TDHS) 2018 data, the rate of breastfeeding is 66% at 12 months, 50% at 18 months, and 34% at 24 months. Considering the decrease according to age, it was assumed that the breastfeeding rate would be 18% after the age of 2. Considering the TDHS 2018 data of mothers, assuming that 18% of mothers breastfeed their babies after the age of 2, with a 95% confidence level and an acceptable sampling error of 0.15, the sample size calculation formula was used to estimate the population ratio, and the sample size was calculated for each mother. It is planned to have at least 25 mothers during the milk collection period (for each mother 18., 24., ≥ 25 months), with a total of 75 breast milk.
Breast milk collections and analysis:
- Breast milk will be collected at 3 separate times at 18th-month, 24th-month and ≥25 months of their babies.
- Using the manual milking method, 5 ml of expressed breast milk will be collected in Eppendorf tubes and transported in a polystyrene box containing ice (at 4°C) to the laboratory within 30 minutes. All breast milk samples will be stored at -20°C under laboratory conditions until the analysis.
- All collected breast milk samples will be prepared for analysis by gradual thawing (breast milk will be taken to +4 C degrees one day before analysis, room temperature on the day of analysis) at the 12th month of the study. The neurotrophic factors (BDNF, S100B, GDNF) will be analyzed with ELISA (Elabsicence; United States) method.
- Conditions
- Breast Milk Collection
- Keywords
- Breast milk, BDNF, GDNF, S100B
- Medical subject headings
- Breast Milk Expression
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of BDNF in the breastmilk at 18 months
Breast milk samples which were collected at the 18th month of the babies and stored in Eppendorf tubes at -20°C will be prepared for analysis by gradual thawing (breast milk will be taken to +4 C degree the day before analysis, room temperature on the day of analysis) in the 12th month of the study and will be analysed for BDNF with ELISA (E-lab-science; United States) method.
Measured: Sample collection: 1-3 months of the study ; Analyze: 12th month of the study
Analysis of BDNF in the breastmilk at 24 months months
Breast milk samples which were collected at the 24th month of the babies and stored in Eppendorf tubes at -20°C will be prepared for analysis by gradual thawing (breast milk will be taken to +4 C degree the day before analysis, room temperature on the day of analysis) in the 12th month of the study and will be analysed for BDNF with ELISA (E-lab-science; United States) method.
Measured: Sample collection: 7-9 months of the study ; Analyze: 12th month of the study
Analysis of BDNF in the breastmilk at ≥25 months
Breast milk samples which were collected after 24th month of the babies and stored in Eppendorf tubes at -20°C will be prepared for analysis by gradual thawing (breast milk will be taken to +4 C degree the day before analysis, room temperature on the day of analysis) in the 12th month of the study and will be analysed for BDNF with ELISA (E-lab-science; United States) method.
Measured: Sample collection: 8-11 months of the study ; Analyze: 12th month of the study
Analysis of GDNF in the breastmilk at 18 months
Breast milk samples which were collected at the 18th month of the babies and stored in Eppendorf tubes at -20°C will be prepared for analysis by gradual thawing (breast milk will be taken to +4 C degree the day before analysis, room temperature on the day of analysis) in the 12th month of the study and will be analysed for GDNF with ELISA (E-lab-science; United States) method.
Measured: Sample collection: 1-3 months of the study ; Analyze: 12th month of the study
Analysis of GDNF in the breastmilk at 24 months
Breast milk samples which were collected at the 24th month of the babies and stored in Eppendorf tubes at -20°C will be prepared for analysis by gradual thawing (breast milk will be taken to +4 C degree the day before analysis, room temperature on the day of analysis) in the 12th month of the study and will be analysed for GDNF with ELISA (E-lab-science; United States) method.
Measured: Sample collection: 7-9 months of the study ; Analyze: 12th month of the study
Analysis of GDNF in the breastmilk at ≥25 months
Breast milk samples which were collected after 24th month of the babies and stored in Eppendorf tubes at -20°C will be prepared for analysis by gradual thawing (breast milk will be taken to +4 C degree the day before analysis, room temperature on the day of analysis) in the 12th month of the study and will be analysed for GDNF with ELISA (E-lab-science; United States) method.
Measured: Sample collection: 8-11 months of the study ; Analyze: 12th month of the study
Analysis of S100B in the breastmilk at 18 months
Breast milk samples which were collected at the 18th month of the babies and stored in Eppendorf tubes at -20°C will be prepared for analysis by gradual thawing (breast milk will be taken to +4 C degree the day before analysis, room temperature on the day of analysis) in the 12th month of the study and will be analysed for S100B with ELISA (E-lab-science; United States) method.
Measured: Sample collection: 1-3 months of the study ; Analyze: 12th month of the study
Analysis of S100B in the breastmilk at 24 months
Breast milk samples which were collected at the 24th month of the babies and stored in Eppendorf tubes at -20°C will be prepared for analysis by gradual thawing (breast milk will be taken to +4 C degree the day before analysis, room temperature on the day of analysis) in the 12th month of the study and will be analysed for S100B with ELISA (E-lab-science; United States) method.
Measured: Sample collection: 7-9 months of the study ; Analyze: 12th month of the study
Analysis of S100B in the breastmilk at ≥25 months
Breast milk samples which were collected after 24th month of the babies and stored in Eppendorf tubes at -20°C will be prepared for analysis by gradual thawing (breast milk will be taken to +4 C degree the day before analysis, room temperature on the day of analysis) in the 12th month of the study and will be analysed for S100B with ELISA (E-lab-science; United States) method.
Measured: Sample collection: 8-11 months of the study ; Analyze: 12th month of the study
Secondary outcomes (3)
Sociodemographic factors
Maternal age, number of pregnancies, number of births
Measured: at the beginning (18. months of age)
Maternal disease
Rate of mothers' diseases other than exclusion criteria, if any
Measured: at the beginning (18. months of age)
Maternal drug use
Rate of medications used by mothers, if any
Measured: at the beginning (18. months of age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start24 Mar 2023
- Primary completion25 Mar 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Milk CollectionStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonca Keskindemirci, Istanbul University
- Investigators
- Gonca Keskindemirci, Assoc Prof, Study director, İstanbul UniveristyÖykü Özbörü Aşkan, PhD, Principal investigator, İstanbul UniveristyGülbin Gökçay, Prof, Principal investigator, İstanbul UniveristyTülin Özden, Prof, Principal investigator, İstanbul UniveristyAlev Bakır Kayı, PhD, Principal investigator, İstanbul Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943847
- Sponsor's protocol ID
- TSA-2023-39668
- Status last verified
- Aug 2023
- First submitted
- 11 Apr 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision will be made after the permission of the authors and authors' institution
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Neurotrophic Growth Factors in Breast Milk at Two Years of Age and Beyond
- ClinicalTrials.gov ID
- NCT05943847
- Acronym / sponsor ID
- TSA-2023-39668
- Conditions
- Breast Milk Collection
- Keywords
- Breast milk, BDNF, GDNF, S100B
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 24 Mar 2023 (actual)
- Primary completion
- 25 Mar 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 13 Jul 2023 (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.
The goal of this observational study is to demonstrate the presence of neurotrophic factors in the breast milk of mothers with 18-month-old children and the persistence of these factors in breast milk after the age of 2 years. The main questions it aims to answer are:
- Does the breast milk of mothers with 18-month-old babies contain Brain-Derived Neurotrophic Factor (BDNF), S100B protein and glial cell line-derived neurotrophic factor (GDNF)?
- Does the breast milk continue to contain BDNF, s100B protein and GDNF and-after 24 months?
Participants will be asked to give breastmilk at 3 separate times. Breast milk samples will be collected from mothers at 18th-month, 24th-month and ≥25 months of their babies. A total of 75 breast milk samples obtained from 25 mothers with their consent will be analyzed.
Detailed description
Growth factors are among the bioactive compounds found in breast milk and have effects on the growth and maturation of the baby's organs and systems. The completion of each organ maturation occurs at different times. Although the development of the nervous system reaches 60% of adults at the age of 2 years, it continues after the age of 2. Brain-Derived Neurotrophic Factor (BDNF), S100B protein, and glial cell line-derived neurotrophic factor (GDNF) are the neurotrophic growth factors found in breast milk and play a critical role in the development of the nervous system, the maintenance of neuronal functionality and the proliferation of neurons . They play a role during brain development, particularly in differentiating neuronal and glial cells. In addition, it is effective in synaptic plasticity and has important roles in the mature nervous system. The presence of neurotrophic factors in breast milk under the age of one has been demonstrated. However, the presence of these factors in breast milk has not been evaluated at 2 years and above. In this study, investigators aimed to demonstrate the presence of neurotrophic factors in the breast milk of mothers with 18-month-old children and the persistence of these factors in breast milk after the age of 2 years.
Study Design:
The study was conducted at Istanbul University, Istanbul Medical Faculty, Department of Pediatrics, Department of Social Pediatrics, Well Child Outpatient Clinic. All mothers participating in the study are informed in detail about the study and the importance of breast milk. According to Turkish Demographic and Health Survey (TDHS) 2018 data, the rate of breastfeeding is 66% at 12 months, 50% at 18 months, and 34% at 24 months. Considering the decrease according to age, it was assumed that the breastfeeding rate would be 18% after the age of 2. Considering the TDHS 2018 data of mothers, assuming that 18% of mothers breastfeed their babies after the age of 2, with a 95% confidence level and an acceptable sampling error of 0.15, the sample size calculation formula was used to estimate the population ratio, and the sample size was calculated for each mother. It is planned to have at least 25 mothers during the milk collection period (for each mother 18., 24., ≥ 25 months), with a total of 75 breast milk.
Breast milk collections and analysis:
- Breast milk will be collected at 3 separate times at 18th-month, 24th-month and ≥25 months of their babies.
- Using the manual milking method, 5 ml of expressed breast milk will be collected in Eppendorf tubes and transported in a polystyrene box containing ice (at 4°C) to the laboratory within 30 minutes. All breast milk samples will be stored at -20°C under laboratory conditions until the analysis.
- All collected breast milk samples will be prepared for analysis by gradual thawing (breast milk will be taken to +4 C degrees one day before analysis, room temperature on the day of analysis) at the 12th month of the study. The neurotrophic factors (BDNF, S100B, GDNF) will be analyzed with ELISA (Elabsicence; United States) method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- On the basis of the inclusion and exclusion criteria 25 mothers will be included in this study
Key inclusion criteria (1 listed)
- Mothers who applied for the 18th-month follow-up of their exclusively breastfed baby for the first 6 months agreed to participate in the study.
Key exclusion criteria (4 listed)
- Mothers of infants who were not exclusively breastfed in the first six months
- Mothers with infection, metabolic disease, central nervous system, breast disease or pregnancy
- Mothers of infants with infection, metabolic disease, malnutrition and central nervous system disease
- Mothers who stop breastfeeding before 25 months
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
Analysis of BDNF in the breastmilk at 18 months
Time frame: Sample collection: 1-3 months of the study ; Analyze: 12th month of the study
Breast milk samples which were collected at the 18th month of the babies and stored in Eppendorf tubes at -20°C will be prepared for analysis by gradual thawing (breast milk will be taken to +4 C degree the day before analysis, room temperature on the day of analysis) in the 12th month of the study and will be analysed for BDNF with ELISA (E-lab-science; United States) method.
Analysis of BDNF in the breastmilk at 24 months months
Time frame: Sample collection: 7-9 months of the study ; Analyze: 12th month of the study
Breast milk samples which were collected at the 24th month of the babies and stored in Eppendorf tubes at -20°C will be prepared for analysis by gradual thawing (breast milk will be taken to +4 C degree the day before analysis, room temperature on the day of analysis) in the 12th month of the study and will be analysed for BDNF with ELISA (E-lab-science; United States) method.
Analysis of BDNF in the breastmilk at ≥25 months
Time frame: Sample collection: 8-11 months of the study ; Analyze: 12th month of the study
Breast milk samples which were collected after 24th month of the babies and stored in Eppendorf tubes at -20°C will be prepared for analysis by gradual thawing (breast milk will be taken to +4 C degree the day before analysis, room temperature on the day of analysis) in the 12th month of the study and will be analysed for BDNF with ELISA (E-lab-science; United States) method.
Analysis of GDNF in the breastmilk at 18 months
Time frame: Sample collection: 1-3 months of the study ; Analyze: 12th month of the study
Breast milk samples which were collected at the 18th month of the babies and stored in Eppendorf tubes at -20°C will be prepared for analysis by gradual thawing (breast milk will be taken to +4 C degree the day before analysis, room temperature on the day of analysis) in the 12th month of the study and will be analysed for GDNF with ELISA (E-lab-science; United States) method.
Analysis of GDNF in the breastmilk at 24 months
Time frame: Sample collection: 7-9 months of the study ; Analyze: 12th month of the study
Breast milk samples which were collected at the 24th month of the babies and stored in Eppendorf tubes at -20°C will be prepared for analysis by gradual thawing (breast milk will be taken to +4 C degree the day before analysis, room temperature on the day of analysis) in the 12th month of the study and will be analysed for GDNF with ELISA (E-lab-science; United States) method.
Analysis of GDNF in the breastmilk at ≥25 months
Time frame: Sample collection: 8-11 months of the study ; Analyze: 12th month of the study
Breast milk samples which were collected after 24th month of the babies and stored in Eppendorf tubes at -20°C will be prepared for analysis by gradual thawing (breast milk will be taken to +4 C degree the day before analysis, room temperature on the day of analysis) in the 12th month of the study and will be analysed for GDNF with ELISA (E-lab-science; United States) method.
Analysis of S100B in the breastmilk at 18 months
Time frame: Sample collection: 1-3 months of the study ; Analyze: 12th month of the study
Breast milk samples which were collected at the 18th month of the babies and stored in Eppendorf tubes at -20°C will be prepared for analysis by gradual thawing (breast milk will be taken to +4 C degree the day before analysis, room temperature on the day of analysis) in the 12th month of the study and will be analysed for S100B with ELISA (E-lab-science; United States) method.
Analysis of S100B in the breastmilk at 24 months
Time frame: Sample collection: 7-9 months of the study ; Analyze: 12th month of the study
Breast milk samples which were collected at the 24th month of the babies and stored in Eppendorf tubes at -20°C will be prepared for analysis by gradual thawing (breast milk will be taken to +4 C degree the day before analysis, room temperature on the day of analysis) in the 12th month of the study and will be analysed for S100B with ELISA (E-lab-science; United States) method.
Analysis of S100B in the breastmilk at ≥25 months
Time frame: Sample collection: 8-11 months of the study ; Analyze: 12th month of the study
Breast milk samples which were collected after 24th month of the babies and stored in Eppendorf tubes at -20°C will be prepared for analysis by gradual thawing (breast milk will be taken to +4 C degree the day before analysis, room temperature on the day of analysis) in the 12th month of the study and will be analysed for S100B with ELISA (E-lab-science; United States) method.
3 secondary outcomes
Sociodemographic factors
Time frame: at the beginning (18. months of age)
Maternal disease
Time frame: at the beginning (18. months of age)
Maternal drug use
Time frame: at the beginning (18. months of age)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Individual participant dataSharing planned: Undecided. The decision will be made after the permission of the authors and authors' institution
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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.
Gonca Keskindemirci, Assoc Prof study director
İstanbul Univeristy
Öykü Özbörü Aşkan, PhD principal investigator
İstanbul Univeristy
Gülbin Gökçay, Prof principal investigator
İstanbul Univeristy
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 Milk Collection, run by Istanbul University at 1 site in Turkey (Türkiye).
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 1 inclusion and 4 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 8 Aug 2023. 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 Turkey (Türkiye). 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?
Contact Gonca Keskindemirci, Assoc Prof (0905324934651, keskindemirci@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of BDNF in the breastmilk at 18 months (time frame: Sample collection: 1-3 months of the study ; Analyze: 12th month of the study). The study lists 9 primary outcomes in all. 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 8 Aug 2023.