Breast MilkMiMilkNCT06651216
Impact of Breast Milk miRNAs on the Infant Gut Microbiota
An observational study of Breast Milk and Stools, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Milk, Stools
- What is being tested?
- Stool analysis and breast milk analysis
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2024to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Mother-child dyad in good health from birth
Who may be able to join
- Pregnant women in the 3rd trimester of pregnancy (3T) with a normal course of pregnancy up to 39 weeks consulting for the monitoring visit at the Robert-Debré hospital.
- Patients who did not receive antibiotic treatment or probiotics in 3T.
- Patient with a negative PV for Strepto B
- Patients who do not have complications such as pre-eclampsia or gestational diabetes.
- Breastfeeding (+/- milk pump) or exclusive artificial breastfeeding.
- No opposition from the mother
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- Ability to master the French language required.
- Freezer at home.
- Affiliation to a social security scheme.
Who cannot join
- Cesarean delivery
- Perinatal pathologies (Anoxia, IUGR, etc.)
- Neonatal pathologies (FGR, malformations, etc.)
- Initial choice of mixed breastfeeding
- Patient under AME (State Medical Aid)Critères d'exclusions :
- Antibiotics for the mother or child before day 60
- Antifungal for the mother or child before day 60
- Complete cessation of breastfeeding before day 60
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Robert Debre Hospital Assistance Publique Hôpitaux de Paris
Paris, 75019
Alexis MOSCA, MD, 01.87.89.16.46, alexis.mosca@aphp.fr
Servane ALIROL-BECHON, PhD, 01.87.89.16.46, servane.alirol-bechon@aphp.fr
About this study
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).
Read more
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.
Read the detailed description
The first 1,000 days of life are a critical period that significantly contributes to the programming of an individual's 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 infant's 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 infant's 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 infant's 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 infant's 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 infant's 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 infant's 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 infant's 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 infant's 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).
- Conditions
- Breast Milk, Stools
- Being tested
- Stool analysis, breast milk analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool analysisOther
Analysis of infant fecal microbiota
breast milk analysisOther
Analysis of the effect of breast milk miRNAs on infant fecal microbiota
| Study group | Role | What they receive |
|---|---|---|
| Breast feeding | Exclusively breastfed infants for 2 months Receives: Other: Stool analysis; Other: breast milk analysis | |
| Non breast feeding | Infants exclusively fed with formula milk Receives: Other: Stool analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Explore the effect of breast milk on the composition of fecal miRNAs in infants
profiles and quantities of miRNAs at different times (D10, D30, D60, M6, and M12) in the stools of exclusively breastfed infants compared to those fed with formula milk
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast MilkStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexis MOSCA, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651216
- Sponsor's protocol ID
- APHP240711
- Other IDs
- IDRCB: 2024-A01059-38
- Acronym
- MiMilk
- Status last verified
- Oct 2024
- First submitted
- 18 Oct 2024
- Last updated
- 21 Oct 2024
- 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 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Breast Milk miRNAs on the Infant Gut Microbiota
- ClinicalTrials.gov ID
- NCT06651216
- Acronym / sponsor ID
- MiMilk / APHP240711
- Conditions
- Breast Milk, Stools
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 21 Oct 2024 (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 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.
Detailed description
The first 1,000 days of life are a critical period that significantly contributes to the programming of an individual's 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 infant's 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 infant's 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 infant's 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 infant's 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 infant's 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 infant's 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 infant's 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 infant's 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast feeding | – | Other: Stool analysis, Other: breast milk analysisExclusively breastfed infants for 2 months |
| Non breast feeding | – | Other: Stool analysisInfants exclusively fed with formula milk |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Mother-child dyad in good health from birth
Key inclusion criteria (9 listed)
- Pregnant women in the 3rd trimester of pregnancy (3T) with a normal course of pregnancy up to 39 weeks consulting for the monitoring visit at the Robert-Debré hospital.
- Patients who did not receive antibiotic treatment or probiotics in 3T.
- Patient with a negative PV for Strepto B
- Patients who do not have complications such as pre-eclampsia or gestational diabetes.
- Breastfeeding (+/- milk pump) or exclusive artificial breastfeeding.
Key exclusion criteria (8 listed)
- Cesarean delivery
- Perinatal pathologies (Anoxia, IUGR, etc.)
- Neonatal pathologies (FGR, malformations, etc.)
- Initial choice of mixed breastfeeding
- Patient under AME (State Medical Aid)Critères d'exclusions :
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stool analysisAnalysis of infant fecal microbiota | Other | Breast feeding, Non breast feeding |
| breast milk analysisAnalysis of the effect of breast milk miRNAs on infant fecal microbiota | Other | Breast feeding |
Primary outcome
Explore the effect of breast milk on the composition of fecal miRNAs in infants
Time frame: 12 months
profiles and quantities of miRNAs at different times (D10, D30, D60, M6, and M12) in the stools of exclusively breastfed infants compared to those fed with formula milk
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- 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.
Alexis MOSCA, MD principal investigator
Assistance Publique - Hôpitaux de Paris
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 and Stools, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 9 inclusion and 8 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: opening soon, as of the sponsor's last update on 21 Oct 2024. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexis MOSCA, MD (0187891646, alexis.mosca@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Explore the effect of breast milk on the composition of fecal miRNAs in infants (time frame: 12 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 21 Oct 2024.