Breastfeeding Mothers of Legal AgeSPECIFI-CNCT07162025
Improving Nutrition for Babies Born by Caesarean Section
An observational study of Breastfeeding Mothers of Legal Age and Their Babies Under 6 Months Old Born Vaginally, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
Trial summary
The ambition of the project is to help with the primal colonisation of babies born by caesarean section and to improve the lipid composition of an infant formula, in order to reduce the short- and long-term health problems associated with caesarean births. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2025to 30 Sep 2028
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Breastfeeding mothers and their babies under 6 months old
Who may be able to join
- Breastfeeding mothers:
- Aged 18 years and older Breastfeeding for less than 6 months Not having taken probiotics in the 6 months prior to sampling Not having taken antibiotics in the 6 months prior to sampling No chronic medical conditions Not undergoing chronic treatment No history of gestational diabetes Body mass index (BMI) below 25 at the start of pregnancy Having given their consent to participate in the study and to the collection of their baby's stool samples Not deprived of liberty or placed under guardianship
- Babies: Aged less than 6 months Born vaginally Born at term or at least 37 weeks of pregnancy Exclusively breastfed Not having received intrapartum antibiotic treatment Having no known medical conditions Not receiving any medical supplements other than conventional vitamins Whose mothers meet the inclusion criteria detailed above
Who cannot join
- Breastfeeding mothers:
- Under the age of 18
- Breastfeeding for 6 months or more
- Having been on antibiotic therapy in the 6 months prior to sampling
- Having taken probiotics in the 6 months prior to sampling
- Having a chronic illness
Show all 21Show fewer
- Undergoing chronic treatment
- Who have developed gestational diabetes
- Who have a BMI greater than 25 at the start of pregnancy
- Who have given their consent to participate in the study (breast milk collection) but not to the collection of their baby's stool samples
- Who are deprived of their liberty or under guardianship.
- Babies:
- Aged over 6 months
- Born by caesarean section
- Born before 37 weeks of pregnancy
- Not exclusively breastfed
- Having undergone intrapartum antibiotic treatment
- Taking medical supplements other than conventional vitamins
- Presenting with any type of pathology
- Whose mothers meet the non-inclusion criteria detailed above
- Receiving medical supplementation other than conventional vitamins
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
ELISE BOREZEE, PhD contact
France1 site, 1 recruiting
- Recruiting
INRAE
Jouy-en-Josas, 78350
REBECA MARTIN ROSIQUE, PhD, rebeca.martin-rosique@inrae.fr
LUCIE CHAIGNON, Midwife
About this study
Official title: Development of a Specific Infant Formula for Babies Born by Caesarean Section
The ambition of the project is to help with the primal colonisation of babies born by caesarean section and to improve the lipid composition of an infant formula, in order to reduce the short- and long-term health problems associated with caesarean births. This population, which represents around 20% of babies born in France, has not yet received any specific care to date.
The study aims to develop an optimized infant formula. It includes: (1) isolation of probiotics from breast milk from nursing mothers and stool samples from their babies born vaginally, (2) formulation of an improved milk enriched with physiological lipids and selected probiotics, and (3) preclinical evaluation of its beneficial effects in a cesarean birth model.
Read the detailed description
The perinatal period represents a critical window during which the establishment of the infant gut microbiota plays a central role in host physiology and immune system development. Cesarean delivery is associated with altered vertical transmission of maternal microbiota, leading to dysregulated host-microbiota interactions and impaired homeostasis. Epidemiological evidence indicates that disturbances in early-life colonization are linked to an increased risk of developing various non-communicable diseases later in life.
Modern obstetric practices, while highly effective in reducing birth complications, have resulted in a high prevalence of cesarean deliveries. Several strategies have been explored to restore the microbiota of cesarean-born infants, including maternal vaginal or fecal microbiota transfer, but these approaches raise significant safety concerns. Breastfeeding has been shown to partially restore the gut microbiota of cesarean-born infants; however, breastfeeding rates are lower after cesarean section than after vaginal delivery, largely due to postnatal complications that interfere with breastfeeding initiation. Although specific infant formulas already exist for certain populations, none are currently designed to address the impaired primary colonization observed in cesarean-born infants.
The SPECIFI-C project has been designed to fill this gap by developing an innovative infant formula tailored to the specific needs of this population. The strategy focuses on two main components: (i) optimization of the microbiological fraction through supplementation with beneficial microorganisms isolated from human breast milk and infant feces, and (ii) optimization of the lipid fraction by incorporating bioactive lipids such as docosahexaenoic acid (DHA) and alkylglycerols, which are naturally present in breast milk but absent from current formulas.
The ultimate objective is to provide a safe and effective nutritional intervention that promotes healthy gut colonization and supports immune and physiological development in cesarean-born infants. By targeting a population that represents approximately 20% of births in France, the project aims to contribute to more precise and personalized nutrition strategies, with the potential to reduce both short- and long-term health risks associated with cesarean delivery.
- Keywords
- caesarean section, breastfeeding
- Medical subject headings
- Breast Feeding
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the viability of supplemented probiotic microorganisms (CFU/g) and levels of bioactive lipids in the experimental infant formula specifically designed for cesarean-born infants
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start30 Sep 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breastfeeding Mothers of Legal AgeStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162025
- Sponsor's protocol ID
- 2025-A00676-43
- Acronym
- SPECIFI-C
- Status last verified
- Oct 2025
- First submitted
- 29 Aug 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Specific Infant Formula for Babies Born by Caesarean Section
- ClinicalTrials.gov ID
- NCT07162025
- Acronym / sponsor ID
- SPECIFI-C / 2025-A00676-43
- Keywords
- caesarean section, breastfeeding
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 9 Sep 2025 (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 ambition of the project is to help with the primal colonisation of babies born by caesarean section and to improve the lipid composition of an infant formula, in order to reduce the short- and long-term health problems associated with caesarean births. This population, which represents around 20% of babies born in France, has not yet received any specific care to date.
The study aims to develop an optimized infant formula. It includes: (1) isolation of probiotics from breast milk from nursing mothers and stool samples from their babies born vaginally, (2) formulation of an improved milk enriched with physiological lipids and selected probiotics, and (3) preclinical evaluation of its beneficial effects in a cesarean birth model.
Detailed description
The perinatal period represents a critical window during which the establishment of the infant gut microbiota plays a central role in host physiology and immune system development. Cesarean delivery is associated with altered vertical transmission of maternal microbiota, leading to dysregulated host-microbiota interactions and impaired homeostasis. Epidemiological evidence indicates that disturbances in early-life colonization are linked to an increased risk of developing various non-communicable diseases later in life.
Modern obstetric practices, while highly effective in reducing birth complications, have resulted in a high prevalence of cesarean deliveries. Several strategies have been explored to restore the microbiota of cesarean-born infants, including maternal vaginal or fecal microbiota transfer, but these approaches raise significant safety concerns. Breastfeeding has been shown to partially restore the gut microbiota of cesarean-born infants; however, breastfeeding rates are lower after cesarean section than after vaginal delivery, largely due to postnatal complications that interfere with breastfeeding initiation. Although specific infant formulas already exist for certain populations, none are currently designed to address the impaired primary colonization observed in cesarean-born infants.
The SPECIFI-C project has been designed to fill this gap by developing an innovative infant formula tailored to the specific needs of this population. The strategy focuses on two main components: (i) optimization of the microbiological fraction through supplementation with beneficial microorganisms isolated from human breast milk and infant feces, and (ii) optimization of the lipid fraction by incorporating bioactive lipids such as docosahexaenoic acid (DHA) and alkylglycerols, which are naturally present in breast milk but absent from current formulas.
The ultimate objective is to provide a safe and effective nutritional intervention that promotes healthy gut colonization and supports immune and physiological development in cesarean-born infants. By targeting a population that represents approximately 20% of births in France, the project aims to contribute to more precise and personalized nutrition strategies, with the potential to reduce both short- and long-term health risks associated with cesarean delivery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Breastfeeding mothers and their babies under 6 months old
Key inclusion criteria (3 listed)
- Breastfeeding mothers:
- Aged 18 years and older Breastfeeding for less than 6 months Not having taken probiotics in the 6 months prior to sampling Not having taken antibiotics in the 6 months prior to sampling No chronic medical conditions Not undergoing chronic treatment No history of gestational diabetes Body mass index (BMI) below 25 at the start of pregnancy Having given their consent to participate in the study and to the collection of their baby's stool samples Not deprived of liberty or placed under guardianship
- Babies: Aged less than 6 months Born vaginally Born at term or at least 37 weeks of pregnancy Exclusively breastfed Not having received intrapartum antibiotic treatment Having no known medical conditions Not receiving any medical supplements other than conventional vitamins Whose mothers meet the inclusion criteria detailed above
Key exclusion criteria (21 listed)
- Under the age of 18
- Breastfeeding for 6 months or more
- Having been on antibiotic therapy in the 6 months prior to sampling
- Having taken probiotics in the 6 months prior to sampling
- Having a chronic illness
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
Measurement of the viability of supplemented probiotic microorganisms (CFU/g) and levels of bioactive lipids in the experimental infant formula specifically designed for cesarean-born infants
Time frame: up to 3 years
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 19 Nov 2025.
- Individual participant dataSharing planned: No
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.
ELISE BOREZEE, PhD contact
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 Breastfeeding Mothers of Legal Age and Their Babies Under 6 Months Old Born Vaginally, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement 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 3 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 19 Nov 2025. 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 REBECA MARTIN-ROSIQUE, PhD (00 33 1 34 65 20 98, rebeca.martin-rosique@inrae.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the viability of supplemented probiotic microorganisms (CFU/g) and levels of bioactive lipids in the experimental infant formula specifically designed for cesarean-born infants (time frame: up to 3 years). 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 19 Nov 2025.