PrematureBaBBaNCT04432636
Gut Bacteria and Brain of the Baby
A study testing Data collection of environmental factors, Collection of maternal feces and Collection of infant feces in people with Premature, run by Rennes University Hospital at 1 site in France.
Trial summary
The project is a prospective French population based cohort. A hundred moderate preterms born at GA30-326/7 will be enrolled for a longitudinal follow-up up to 2 years of corrected age. Read more about this study
- Who is it for?
- Ages 30 to 32 weeks
- Conditions the study is for
- Premature
- What is being tested?
- Data collection of environmental factors, Collection of maternal feces and Collection of infant feces
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteFrance
- Study dates
- 29 Mar 2021to 9 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterms born at gestational age of 30-326/7 weeks of amenorrhea
- Preterms born in Rennes hospital or preterms born in another hospital but moved to Rennes hospital during the first 24 h of postnatal life
- Parents or holder of the parental authority who give in writing their free, prior and informed consent for recruitment of their baby who has a social security system
- Mother of the baby who gives in writing her free, prior and informed consent to be involved in the present study
- Mother of the baby who has a social security system
Who cannot join
- Preterms born with a genetic disease
- Preterms born with a digestive defect
- Uncompetent parents under the protection of guardianship or tutelage services
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gut Bacteria and Brain of the Baby: to Link up the Dynamic of Gut Colonization in Preterms Born at Gestational Age of 30-326/7 Weeks and Their Psychomotor Development at 2 Years
The project is a prospective French population based cohort. A hundred moderate preterms born at GA30-326/7 will be enrolled for a longitudinal follow-up up to 2 years of corrected age. Eligible neonates will be those born at 30-326/7 weeks of gestation admitted to the neonatal intensive care unit of Rennes Hospital, including transferred infants during the first day of life. The infants will be followed up to the corrected age of 2 years by pediatricians.
- Conditions
- Premature
- Being tested
- Data collection of environmental factors, Collection of maternal feces, Collection of infant feces, food questionnaire, a food questionnaire on the infant alimentation and food behavior during the period of 2 and 10 months of age
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection of environmental factorsOther
- Data collection of environmental factors (including maternal nutrition and social level, mode of delivery, birth weight, mode of infant feeding, antibiotic treatments) at the recruitment
Collection of maternal fecesOther
- Collection of maternal feces: the first sample after delivery and once a week during the period of hospitalization of their infant (i.e. 5 to 8 samples per mother)
Collection of infant fecesOther
- Collection of infant feces: the first sample after birth and once a week during the period of hospitalization of the baby (i.e. 5 to 8 samples per mother) and a sample collected at the corrected age of 1 year and 2 years (i.e. 8 to 10 samples per infant)
food questionnaireOther
- A food questionnaire completed by the mother the week after delivery,
a food questionnaire on the infant alimentation and food behavior during the period of 2 and 10 months of ageOther
a food questionnaire on the infant alimentation and food behavior during the period of 2 and 10 months of age, completed by the parents and given to the pediatrician at the medical check-up at the corrected age of 1 year
a food questionnaire on the infant alimentation and food behavior during the period of 12 and 24 months of ageOther
a food questionnaire on the infant alimentation and food behavior during the period of 12 and 24 months of age, completed by the parents and given to the pediatrician at the medical check-up at the corrected age of 2 years
Sample of milkOther
A sample of 15 mL of milk drunk by the preterm at the 7th postnatal day (if not possible between the 7th and the 10th postnatal days).
The 'Ages and Stages Questionnaire' ASQOther
- The 'Ages and Stages Questionnaire' ASQ survey completed by the parents and given to the pediatrician at the corrected age of 2 years medical check-up
| Study group | Role | What they receive |
|---|---|---|
| Prospective French population based cohort | Other | * Data collection of environmental factors at the recruitment
* Collection of maternal feces
* Collection of infant feces:
* A food questionnaire completed by the mother the week after delivery, a food questionnaire on the infant alimentation and food behavior during the period of 2 and 10 months of age, completed by the parents and given to the pediatrician at the medical check-up at the corrected age of 1 year and a food questionnaire on the infant alimentation and food behavior during the period of 12 and 24 months of age, completed by the parents and given to the pediatrician at the medical check-up at the corrected age of 2 years
* A sample of 15 mL of milk drunk by the preterm at the 7th postnatal day
* The 'Ages and Stages Questionnaire' ASQ survey completed by the parents and given to the pediatrician at the corrected age of 2 years medical check-up Receives: Other: Data collection of environmental factors; Other: Collection of maternal feces; Other: Collection of infant feces; Other: food questionnaire; Other: a food questionnaire on the infant alimentation and food behavior during the period of 2 and 10 months of age; Other: a food questionnaire on the infant alimentation and food behavior during the period of 12 and 24 months of age; Other: Sample of milk; Other: The 'Ages and Stages Questionnaire' ASQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
to associate preterms microbial profiles and psychomotor outcomes at 2 years of corrected age using the 'Ages and Stages Questionnaire' ASQ survey
To associate preterms microbial profiles (bacteria and fungi; alpha- and beta-diversity, abundancies and complex interactions between neonatal microbiotas) and psychomotor outcomes at 2 years of corrected age using the 'Ages and Stages Questionnaire' survey. Each questionnaire includes 30 items covering five developmental domains: communication abilities, gross motor skills, fine motor skills, problem solving abilities, and personal-social skills. Items are scored on a three point scale depending on whether the child performs the task: yes (10 points), sometimes (5 points), or not yet (0 points). Responses are summed to give a score of 0 to 60 for each domain and an overall maximum ASQ score of 300 points. Analyses were based on domain specific scores, using established screening cut-off points: an ASQ score below threshold was defined as a score lower than 2 standard deviations from the mean on any of the five domains.
Measured: at 2 years of corrected age
Secondary outcomes (12)
interactions between maternal and neonatal microbiotas - 2
Pearson correlation values between maternal microbiota composition and infant gut microbiota composition from birth up to 2 years at corrected age..
Measured: at 2 years of corrected age
interactions between maternal and neonatal microbiotas - 1
.Pearson correlation values between maternal microbiota composition and infant gut microbiota composition from birth up to 1 year at corrected age.
Measured: at 1 year of corrected age
Bacterial and fongal microbiotas
Pearson correlation values between bacterial (16S) and fongal (18S) microbiota composition in infant from birth up to 1 year at corrected age.
Measured: at 1 year of corrected age
Bacterial and fongal microbiotas
Pearson correlation values between bacterial (16S) and fongal (18S) microbiota composition in infant from birth up to 2 years at corrected age.
Measured: at 2 years of corrected age
maternal dietary profiles and maternal microbiota
- Correlation between maternal dietary profiles (food questionnaire completed by the mother the week after delivery) and maternal microbiota. Associations between clinical metadata, dietary profiles and microbial community abundance will be investigate by Multivariate Association with Linear Models (MaAslin).
Measured: up to 8 weeks after delivery
maternal dietary profiles and maternal microbiota
- Correlation between maternal dietary profiles (food questionnaire completed by the mother the week after delivery) and maternal microbiota. Associations between clinical metadata, dietary profiles and microbial community abundance will be investigate by Multivariate Association with Linear Models (MaAslin).
Measured: up to one week after delivery
maternal dietary profiles and maternal milk composition
- Correlation between maternal dietary profiles (food questionnaire completed by the mother the week after delivery) and maternal milk (a sample of milk drunk by the preterm at the 7th postnatal day, if not possible between the 7th and the 10th postnatal days) composition. The interactions will be assessed by Pearson correlation analysis and drewing the interaction network using Cystoscape package in R.
Measured: at the 7th postnatal day
maternal dietary profiles, maternal milk composition and preterms gut microbiotas
- Correlation between maternal maternal dietary profiles (food questionnaire completed by the mother the week after delivery) and maternal milk (a sample of milk drunk by the preterm at the 7th postnatal day, if not possible between the 7th and the 10th postnatal days) composition and preterms gut microbiotas collection of infant feces: the first sample after birth and once a week during the period of hospitalization of the baby (i.e. 5 to 8 samples per infant) and a sample collected at the corrected age of 1 year and 2 years (i.e. 8 to 10 samples per infant). Associations between clinical metadata, dietary profiles and milk composition, and microbial community abundance will be investigate by Multivariate Association with Linear Models (MaAslin) and by applying Markov Decision Process (MDPs) to take into account the analysis of microbiota dynamics
Measured: Up to the 2 years of the baby
Dietary profile and gut microbia composition
Correlation between 1-y infant dietary profile and 1-y infant gut microbiota composition. Associations between infant dietary profiles and microbial community abundance will be investigate by Multivariate Association with Linear Models (MaAslin) and by applying Markov Decision Process (MDPs) to take into account the analysis of microbiota dynamics
Measured: at 1 year of corrected age
Dietary profile and gut microbia composition
Correlation between 1-y infant dietary profile and 2-y infant gut microbiota composition. Associations between infant dietary profiles and microbial community abundance will be investigate by Multivariate Association with Linear Models (MaAslin) and by applying Markov Decision Process (MDPs) to take into account the analysis of microbiota dynamics
Measured: at 2 years of corrected age
Gut microbia
Functional activity of gut microbiota (in vitro test using 1-y infant fecal samples). Endocrine and barrier function responses of an in vitro tricellular model of intestinal epithelium (including enterocytes, mucin-secreting cells and entero-endocrine cells) to the stimulation by fecal water from 1-y infant feces will be characterized.
Measured: at 1 year of corrected age
Gut microbia
Functional activity of gut microbiota (in vitro test using 1-y infant fecal samples). Endocrine and barrier function responses of an in vitro tricellular model of intestinal epithelium (including enterocytes, mucin-secreting cells and entero-endocrine cells) to the stimulation by fecal water from 1-y infant feces will be characterized.
Measured: at 2 years of corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start29 Mar 2021
- Primary completion9 Apr 2026
- Study completion9 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematureStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432636
- Sponsor's protocol ID
- 35RC19_9784_BaBBa
- Acronym
- BaBBa
- Status last verified
- Jun 2026
- First submitted
- 19 Feb 2020
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Bacteria and Brain of the Baby: to Link up the Dynamic of Gut Colonization in Preterms Born at Gestational Age of 30-326/7 Weeks and Their Psychomotor Development at 2 Years
- ClinicalTrials.gov ID
- NCT04432636
- Acronym / sponsor ID
- BaBBa / 35RC19_9784_BaBBa
- Conditions
- Premature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 9 Apr 2026 (actual)
- Study completion
- 9 Apr 2026 (actual)
- First posted
- 16 Jun 2020 (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 project is a prospective French population based cohort. A hundred moderate preterms born at GA30-326/7 will be enrolled for a longitudinal follow-up up to 2 years of corrected age. Eligible neonates will be those born at 30-326/7 weeks of gestation admitted to the neonatal intensive care unit of Rennes Hospital, including transferred infants during the first day of life. The infants will be followed up to the corrected age of 2 years by pediatricians.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective French population based cohort | Other | Other: Data collection of environmental factors, Other: Collection of maternal feces, Other: Collection of infant feces, Other: food questionnaire, Other: a food questionnaire on the infant alimentation and food behavior during the period of 2 and 10 months of age, Other: a food questionnaire on the infant alimentation and food behavior during the period of 12 and 24 months of age, Other: Sample of milk, Other: The 'Ages and Stages Questionnaire' ASQ* Data collection of environmental factors at the recruitment * Collection of maternal feces * Collection of infant feces: * A food questionnaire completed by the mother the week after delivery, a food questionnaire on the infant alimentation and food behavior during the period of 2 and 10 months of age, completed by the parents and given to the pediatrician at the medical check-up at the corrected age of 1 year and a food questionnaire on the infant alimentation and food behavior during the period of 12 and 24 months of age, completed by the parents and given to the pediatrician at the medical check-up at the corrected age of 2 years * A sample of 15 mL of milk drunk by the preterm at the 7th postnatal day * The 'Ages and Stages Questionnaire' ASQ survey completed by the parents and given to the pediatrician at the corrected age of 2 years medical check-up |
Who may qualify
- Ages
- 30 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Preterms born at gestational age of 30-326/7 weeks of amenorrhea
- Preterms born in Rennes hospital or preterms born in another hospital but moved to Rennes hospital during the first 24 h of postnatal life
- Parents or holder of the parental authority who give in writing their free, prior and informed consent for recruitment of their baby who has a social security system
- Mother of the baby who gives in writing her free, prior and informed consent to be involved in the present study
- Mother of the baby who has a social security system
Key exclusion criteria (3 listed)
- Preterms born with a genetic disease
- Preterms born with a digestive defect
- Uncompetent parents under the protection of guardianship or tutelage services
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 |
|---|---|---|
| Data collection of environmental factors- Data collection of environmental factors (including maternal nutrition and social level, mode of delivery, birth weight, mode of infant feeding, antibiotic treatments) at the recruitment | Other | Prospective French population based cohort |
| Collection of maternal feces- Collection of maternal feces: the first sample after delivery and once a week during the period of hospitalization of their infant (i.e. 5 to 8 samples per mother) | Other | Prospective French population based cohort |
| Collection of infant feces- Collection of infant feces: the first sample after birth and once a week during the period of hospitalization of the baby (i.e. 5 to 8 samples per mother) and a sample collected at the corrected age of 1 year and 2 years (i.e. 8 to 10 samples per infant) | Other | Prospective French population based cohort |
| food questionnaire- A food questionnaire completed by the mother the week after delivery, | Other | Prospective French population based cohort |
| a food questionnaire on the infant alimentation and food behavior during the period of 2 and 10 months of agea food questionnaire on the infant alimentation and food behavior during the period of 2 and 10 months of age, completed by the parents and given to the pediatrician at the medical check-up at the corrected age of 1 year | Other | Prospective French population based cohort |
| a food questionnaire on the infant alimentation and food behavior during the period of 12 and 24 months of agea food questionnaire on the infant alimentation and food behavior during the period of 12 and 24 months of age, completed by the parents and given to the pediatrician at the medical check-up at the corrected age of 2 years | Other | Prospective French population based cohort |
| Sample of milkA sample of 15 mL of milk drunk by the preterm at the 7th postnatal day (if not possible between the 7th and the 10th postnatal days). | Other | Prospective French population based cohort |
| The 'Ages and Stages Questionnaire' ASQ- The 'Ages and Stages Questionnaire' ASQ survey completed by the parents and given to the pediatrician at the corrected age of 2 years medical check-up | Other | Prospective French population based cohort |
Primary outcome
to associate preterms microbial profiles and psychomotor outcomes at 2 years of corrected age using the 'Ages and Stages Questionnaire' ASQ survey
Time frame: at 2 years of corrected age
To associate preterms microbial profiles (bacteria and fungi; alpha- and beta-diversity, abundancies and complex interactions between neonatal microbiotas) and psychomotor outcomes at 2 years of corrected age using the 'Ages and Stages Questionnaire' survey. Each questionnaire includes 30 items covering five developmental domains: communication abilities, gross motor skills, fine motor skills, problem solving abilities, and personal-social skills. Items are scored on a three point scale depending on whether the child performs the task: yes (10 points), sometimes (5 points), or not yet (0 points). Responses are summed to give a score of 0 to 60 for each domain and an overall maximum ASQ score of 300 points. Analyses were based on domain specific scores, using established screening cut-off points: an ASQ score below threshold was defined as a score lower than 2 standard deviations from the mean on any of the five domains.
12 secondary outcomes
interactions between maternal and neonatal microbiotas - 2
Time frame: at 2 years of corrected age
interactions between maternal and neonatal microbiotas - 1
Time frame: at 1 year of corrected age
Bacterial and fongal microbiotas
Time frame: at 1 year of corrected age
Bacterial and fongal microbiotas
Time frame: at 2 years of corrected age
maternal dietary profiles and maternal microbiota
Time frame: up to 8 weeks after delivery
maternal dietary profiles and maternal microbiota
Time frame: up to one week after delivery
maternal dietary profiles and maternal milk composition
Time frame: at the 7th postnatal day
maternal dietary profiles, maternal milk composition and preterms gut microbiotas
Time frame: Up to the 2 years of the baby
Dietary profile and gut microbia composition
Time frame: at 1 year of corrected age
Dietary profile and gut microbia composition
Time frame: at 2 years of corrected age
Gut microbia
Time frame: at 1 year of corrected age
Gut microbia
Time frame: at 2 years of corrected age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Data collection of environmental factors, Collection of maternal feces and Collection of infant feces in people with Premature, run by Rennes University Hospital 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 12 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to associate preterms microbial profiles and psychomotor outcomes at 2 years of corrected age using the 'Ages and Stages Questionnaire' ASQ survey (time frame: at 2 years of corrected age). 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 12 Jun 2026.