Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06651216
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-18
Brief Title:
Impact of Breast Milk miRNAs on the Infant Gut Microbiota
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of Breast Milk miRNAs on the Infant Gut Microbiota
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MiMilk
Brief Summary:
The first 1000 days of life are a critical period for future health A healthy gut microbiota GM is essential for preventing both short-term and long-term health issues Breast milk BM plays a key role in establishing the GM as unlike formula milk it contains miRNAs that may interact with and modulate the microbiota
Primary Objective To study the effect of BM on the composition of fecal miRNAs in exclusively breastfed infants compared to those fed with formula milk at different times D10 D30 D60 M6 M12
Secondary Objectives
Analyze the effect of BM miRNAs on infant fecal microbiota taking environmental confounding factors into account
Study the influence of BM microbiota on miRNA profiles in the milk Examine the effect of BM microbiota on the infants gut microbiota Explore the links between BM miRNAs infant gut microbiota and intestinal inflammation
Primary Objective To study the effect of BM on the composition of fecal miRNAs in exclusively breastfed infants compared to those fed with formula milk at different times D10 D30 D60 M6 M12
Secondary Objectives
Analyze the effect of BM miRNAs on infant fecal microbiota taking environmental confounding factors into account
Study the influence of BM microbiota on miRNA profiles in the milk Examine the effect of BM microbiota on the infants gut microbiota Explore the links between BM miRNAs infant gut microbiota and intestinal inflammation
Detailed Description:
The first 1000 days of life are a critical period that significantly contributes to the programming of an individuals health It is increasingly evident that establishing a healthy gut microbiota GM plays an important role in preventing both short- and long-term health issues
Among the factors influencing the establishment of the infants gut microbiota breast milk BM plays a fundamental role Unlike formula milk breast milk contains miRNAs that are potential mediators of the interactions between the host and the microbiota Thus we hypothesize that miRNAs from breast milk may be present in the infants luminal content and interact with their microbiota thereby modulating it
Main Objective Explore the effect of breast milk on the composition of fecal miRNAs in infants
Primary Evaluation Criterion Profiles and quantities of miRNAs at different time points D10 D30 D60 M6 and M12 in the stools of exclusively breastfed infants compared to those fed with formula milk
Secondary Objectives
Study the effect of miRNAs from breast milk on the composition of the infants fecal microbiota considering environmental confounding factors including the composition of maternal microbiota
Investigate the effect of breast milk microbiota on the miRNA profiles present in the milk
Study the effect of breast milk microbiota on the gut microbiota of infants Explore the links between breast milk miRNAs the infants gut microbiota and intestinal inflammation in infants
Secondary Evaluation Criteria
Correlations between breast milk miRNA profiles from D1 to D60 and the gut microbiota of breastfed infants from D1 to M12
Correlations between the breast milk microbiota and the breast milk miRNA profiles from D1 to D60
Correlations between breast milk microbiota from D1 to D60 and the infant fecal microbiota from D1 to M12
Direct correlations between 1 breast milk miRNAs and the measurement of fecal calprotectin in infants from D1 to D60 and 2 the infants gut microbiota and fecal calprotectin in infants from D1 to D60
To address the research question we plan to include 200 mother-infant dyads Our goal is to have 30 dyads with exclusive breastfeeding for at least two months and 30 dyads where the infant will not have received any breast milk Each dyad will participate in the study for a period of 12 months and the recruitment phase will last for 18 months
At the infants birth we will collect stool samples from both the mother and the infant as well as a breast milk sample from the mother
At 10 30 and 60 days after the infants birth we will request both a breast milk sample from the mother and a stool sample from the infant
At 6 and 12 months only a stool sample from the infant will be collected During each visit a clinical research coordinator will contact the mothers to gather information about both their health and diet as well as their infants health and diet
Analysis of miRNAs in Breast Milk and Stool Samples miRNAs will be extracted from infant stool samples and breast milk using next-generation Illumina sequencing NGS The top 10 most abundant miRNAs will then be validated through qPCR The overall miRNA profiles will be analyzed using Principal Coordinate Analysis PCoA
Analysis of Gut and Breast Milk Microbiota Stool and breast milk samples will be used for 16S rRNA gene sequencing to analyze the microbial composition Microbiota profiles will also be examined using Principal Coordinate Analysis PCoA
Among the factors influencing the establishment of the infants gut microbiota breast milk BM plays a fundamental role Unlike formula milk breast milk contains miRNAs that are potential mediators of the interactions between the host and the microbiota Thus we hypothesize that miRNAs from breast milk may be present in the infants luminal content and interact with their microbiota thereby modulating it
Main Objective Explore the effect of breast milk on the composition of fecal miRNAs in infants
Primary Evaluation Criterion Profiles and quantities of miRNAs at different time points D10 D30 D60 M6 and M12 in the stools of exclusively breastfed infants compared to those fed with formula milk
Secondary Objectives
Study the effect of miRNAs from breast milk on the composition of the infants fecal microbiota considering environmental confounding factors including the composition of maternal microbiota
Investigate the effect of breast milk microbiota on the miRNA profiles present in the milk
Study the effect of breast milk microbiota on the gut microbiota of infants Explore the links between breast milk miRNAs the infants gut microbiota and intestinal inflammation in infants
Secondary Evaluation Criteria
Correlations between breast milk miRNA profiles from D1 to D60 and the gut microbiota of breastfed infants from D1 to M12
Correlations between the breast milk microbiota and the breast milk miRNA profiles from D1 to D60
Correlations between breast milk microbiota from D1 to D60 and the infant fecal microbiota from D1 to M12
Direct correlations between 1 breast milk miRNAs and the measurement of fecal calprotectin in infants from D1 to D60 and 2 the infants gut microbiota and fecal calprotectin in infants from D1 to D60
To address the research question we plan to include 200 mother-infant dyads Our goal is to have 30 dyads with exclusive breastfeeding for at least two months and 30 dyads where the infant will not have received any breast milk Each dyad will participate in the study for a period of 12 months and the recruitment phase will last for 18 months
At the infants birth we will collect stool samples from both the mother and the infant as well as a breast milk sample from the mother
At 10 30 and 60 days after the infants birth we will request both a breast milk sample from the mother and a stool sample from the infant
At 6 and 12 months only a stool sample from the infant will be collected During each visit a clinical research coordinator will contact the mothers to gather information about both their health and diet as well as their infants health and diet
Analysis of miRNAs in Breast Milk and Stool Samples miRNAs will be extracted from infant stool samples and breast milk using next-generation Illumina sequencing NGS The top 10 most abundant miRNAs will then be validated through qPCR The overall miRNA profiles will be analyzed using Principal Coordinate Analysis PCoA
Analysis of Gut and Breast Milk Microbiota Stool and breast milk samples will be used for 16S rRNA gene sequencing to analyze the microbial composition Microbiota profiles will also be examined using Principal Coordinate Analysis PCoA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None