Neurotrophic Growth Factors in Breast Milk
Evaluation of Neurotrophic Growth Factors in Breast Milk at Two Years of Age and Beyond
1 other identifier
observational
25
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 24, 2023
CompletedFirst Submitted
Initial submission to the registry
April 11, 2023
CompletedFirst Posted
Study publicly available on registry
July 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedAugust 8, 2023
August 1, 2023
1 year
April 11, 2023
August 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
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.
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.
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.
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.
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.
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.
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.
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.
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.
Sample collection: 8-11 months of the study ; Analyze: 12th month of the study
Secondary Outcomes (3)
Sociodemographic factors
at the beginning (18. months of age)
Maternal disease
at the beginning (18. months of age)
Maternal drug use
at the beginning (18. months of age)
Eligibility Criteria
On the basis of the inclusion and exclusion criteria 25 mothers will be included in this study
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
İstanbul University İstanbul Medical Faculty Department of Pediatrics Division of Social Pediatrics
Istanbul, Turkey (Türkiye)
Biospecimen
Breast milk will be stored due to analysis at 12th months of the study
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gonca Keskindemirci, Assoc Prof
İstanbul Univeristy
- PRINCIPAL INVESTIGATOR
Öykü Özbörü Aşkan, PhD
İstanbul Univeristy
- PRINCIPAL INVESTIGATOR
Gülbin Gökçay, Prof
İstanbul Univeristy
- PRINCIPAL INVESTIGATOR
Tülin Özden, Prof
İstanbul Univeristy
- PRINCIPAL INVESTIGATOR
Alev Bakır Kayı, PhD
İstanbul Univeristy
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc Prof
Study Record Dates
First Submitted
April 11, 2023
First Posted
July 13, 2023
Study Start
March 24, 2023
Primary Completion
March 25, 2024
Study Completion
June 1, 2024
Last Updated
August 8, 2023
Record last verified: 2023-08