Healthy Newborn InfantsCROSS-TIVITYNCT07899333
Impact of Delivery Mode on Infant Gut Microbiota, Visceral Sensitivity, and the Neuroenteric System
An observational study of Healthy Newborn Infants, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
Trial summary
The bacteria and other microorganisms that naturally live in the gut (the gut microbiome) play an important role in a baby's early development. Babies born by cesarean section are exposed to different microorganisms at birth than babies born vaginally, which may affect the normal establishment of the gut… Read more about this study
- Who is it for?
- Ages 2 to 4 days
- Conditions the study is for
- Healthy Newborn Infants
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 26 Oct 2026to Oct 2030
- 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 2 to 4 days
- All sexes
- No healthy volunteers
- Child
Study population: Babies born vaginally or by cesarean section (2 to 4 days old)
Who may be able to join
- 2 to 4 days old
- Born vaginally or by cesarean section
- Gestational age at birth ≥ 37 weeks of amenorrhea
- Exclusively breastfed
- With no known medical conditions
- Not receiving any medical supplements other than standard vitamins
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- Whose mothers did not take antibiotics during the third trimester of pregnancy, other than those administered at the time of the cesarean section
- Whose mothers did not take probiotics during the third trimester of pregnancy
- Whose mothers did not have gestational diabetes
- Whose mothers do not have any known chronic medical conditions
- Whose mothers did not undergo any chronic treatment
- Whose mothers had a body mass index (BMI) below 25 at the start of pregnancy
- Whose mothers provided consent to participate in the study and to have their babies' stool samples collected
- Whose mothers are not deprived of their liberty or under legal guardianship
Who cannot join
- Older than 4 days
- Born before 37 weeks of gestation
- Not exclusively breastfed
- Receiving medical supplementation other than conventional vitamins
- With any type of medical condition
- Whose mothers are under 18 years of age
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- Whose mothers received antibiotic therapy during the third trimester of pregnancy
- Whose mothers took probiotics during the third trimester of pregnancy
- Whose mothers have a chronic illness
- Whose mothers are undergoing chronic treatment
- Whose mothers developed gestational diabetes
- Whose mothers had a BMI greater than 25 at the start of pregnancy
- Whose mothers did not give consent to participate in the collection of their baby's stool samples
- Whose mothers are deprived of their liberty or under legal guardianship
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, 1 recruiting
- Recruiting
Hopital Paris-Saclay (GHNE)
Orsay, 91400
AMIRA BOUHENNA, clinical trial technician, 00 33 1 69 15 96 34, j.poline@ghne.fr
JULIE POLINE, M.D
About this study
Official title: The Role of Alterations in Trophic Cooperation Early in Life on Visceral Sensitivity
The bacteria and other microorganisms that naturally live in the gut (the gut microbiome) play an important role in a baby's early development. Babies born by cesarean section are exposed to different microorganisms at birth than babies born vaginally, which may affect the normal establishment of the gut microbiome.Early changes in the gut microbiome can affect the development and function of the immune system, as well as metabolism and gut function, and may increase the risk of certain diseases later in life. They have also been associated with infant colic, a common condition that may be related to increased sensitivity to abdominal pain.
Current approaches to restore the gut microbiome after cesarean birth, such as transferring the mother's vaginal or fecal microbiota, raise important safety concerns. This study aims to better understand how differences in the early gut microbiome influence gut development, immune function, and pain sensitivity, and to identify naturally occurring beneficial bacteria that could provide a safer alternative.
To achieve this, the researchers will study stool samples from newborns delivered vaginally or by cesarean section. Gut bacteria will be isolated and characterized in the laboratory, and selected microorganisms will be evaluated in preclinical models to better understand their effects on gut and immune development. The findings may support the development of new probiotic approaches to promote healthy gut microbiome development in infants born by cesarean section and reduce the long-term health consequences of early microbiome disruption.
- Conditions
- Healthy Newborn Infants
- Keywords
- microbiome, cesarean birth, born vaginally, immune development, gut development
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of colorectal distension in a germ-free mouse model colonized with an altered early human microbiota
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start26 Oct 2026
- Primary completionOct 2030 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Newborn InfantsStudies 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
- Investigators
- JULIE POLINE, Principal investigator, Hopital Paris-Saclay (GHNE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899333
- Sponsor's protocol ID
- 2025-A02886-43
- Acronym
- CROSS-TIVITY
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 28 Oct 2026
- 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Alterations in Trophic Cooperation Early in Life on Visceral Sensitivity
- ClinicalTrials.gov ID
- NCT07899333
- Acronym / sponsor ID
- CROSS-TIVITY / 2025-A02886-43
- Conditions
- Healthy Newborn Infants
- Keywords
- microbiome, cesarean birth, born vaginally, immune development, gut development
- 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
- 26 Oct 2026 (actual)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 27 Oct 2026 (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 bacteria and other microorganisms that naturally live in the gut (the gut microbiome) play an important role in a baby's early development. Babies born by cesarean section are exposed to different microorganisms at birth than babies born vaginally, which may affect the normal establishment of the gut microbiome.Early changes in the gut microbiome can affect the development and function of the immune system, as well as metabolism and gut function, and may increase the risk of certain diseases later in life. They have also been associated with infant colic, a common condition that may be related to increased sensitivity to abdominal pain.
Current approaches to restore the gut microbiome after cesarean birth, such as transferring the mother's vaginal or fecal microbiota, raise important safety concerns. This study aims to better understand how differences in the early gut microbiome influence gut development, immune function, and pain sensitivity, and to identify naturally occurring beneficial bacteria that could provide a safer alternative.
To achieve this, the researchers will study stool samples from newborns delivered vaginally or by cesarean section. Gut bacteria will be isolated and characterized in the laboratory, and selected microorganisms will be evaluated in preclinical models to better understand their effects on gut and immune development. The findings may support the development of new probiotic approaches to promote healthy gut microbiome development in infants born by cesarean section and reduce the long-term health consequences of early microbiome disruption.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 4 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Babies born vaginally or by cesarean section (2 to 4 days old)
Key inclusion criteria (14 listed)
- 2 to 4 days old
- Born vaginally or by cesarean section
- Gestational age at birth ≥ 37 weeks of amenorrhea
- Exclusively breastfed
- With no known medical conditions
Key exclusion criteria (14 listed)
- Older than 4 days
- Born before 37 weeks of gestation
- Not exclusively breastfed
- Receiving medical supplementation other than conventional vitamins
- With any type of medical condition
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
Measure of colorectal distension in a germ-free mouse model colonized with an altered early human microbiota
Time frame: up to 4 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 28 Oct 2026.
- 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.
JULIE POLINE principal investigator
Hopital Paris-Saclay (GHNE)
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 Healthy Newborn Infants, 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 14 inclusion and 14 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 28 Oct 2026. 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 (+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?
Measure of colorectal distension in a germ-free mouse model colonized with an altered early human microbiota (time frame: up to 4 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 28 Oct 2026.