- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04432636
Gut Bacteria and Brain of the Baby (BaBBa)
March 27, 2023 updated by: Rennes University Hospital
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
- 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
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amandine BELLANGER
- Phone Number: +33 02 99 23 48 21
- Email: amandine.bellanger@chu-rennes.fr
Study Locations
-
-
-
Rennes, France
- Recruiting
- CHU Rennes - Hôpital sud
-
Contact:
- Amandine Bellanger
- Phone Number: +33 2 99 23 48 21
- Email: amandine.bellanger@chu-rennes.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 7 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Preterms born with a genetic disease
- Preterms born with a digestive defect
- Uncompetent parents under the protection of guardianship or tutelage services
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Prospective French population based cohort
|
- 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 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 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)
- 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
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 (if not possible between the 7th and the 10th postnatal days).
- 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
at 2 years of corrected age
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
interactions between maternal and neonatal microbiotas - 2
Time Frame: at 2 years of corrected age
|
Pearson correlation values between maternal microbiota composition and infant gut microbiota composition from birth up to 2 years at corrected age..
|
at 2 years of corrected age
|
interactions between maternal and neonatal microbiotas - 1
Time Frame: at 1 year of corrected age
|
.Pearson correlation values between maternal microbiota composition and infant gut microbiota composition from birth up to 1 year at corrected age.
|
at 1 year of corrected age
|
Bacterial and fongal microbiotas
Time Frame: at 1 year of corrected age
|
Pearson correlation values between bacterial (16S) and fongal (18S) microbiota composition in infant from birth up to 1 year at corrected age.
|
at 1 year of corrected age
|
Bacterial and fongal microbiotas
Time Frame: at 2 years of corrected age
|
Pearson correlation values between bacterial (16S) and fongal (18S) microbiota composition in infant from birth up to 2 years at corrected age.
|
at 2 years of corrected age
|
maternal dietary profiles and maternal microbiota
Time Frame: up to 8 weeks after delivery
|
- 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).
|
up to 8 weeks after delivery
|
maternal dietary profiles and maternal microbiota
Time Frame: up to one week after delivery
|
- 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).
|
up to one week after delivery
|
maternal dietary profiles and maternal milk composition
Time Frame: at the 7th postnatal day
|
- 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.
|
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
|
- 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
|
Up to the 2 years of the baby
|
Dietary profile and gut microbia composition
Time Frame: at 1 year of corrected age
|
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
|
at 1 year of corrected age
|
Dietary profile and gut microbia composition
Time Frame: at 2 years of corrected age
|
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
|
at 2 years of corrected age
|
Gut microbia
Time Frame: at 1 year of corrected age
|
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.
|
at 1 year of corrected age
|
Gut microbia
Time Frame: at 2 years of corrected age
|
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.
|
at 2 years of corrected age
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 29, 2021
Primary Completion (Anticipated)
September 1, 2026
Study Completion (Anticipated)
September 1, 2026
Study Registration Dates
First Submitted
February 19, 2020
First Submitted That Met QC Criteria
June 11, 2020
First Posted (Actual)
June 16, 2020
Study Record Updates
Last Update Posted (Actual)
March 28, 2023
Last Update Submitted That Met QC Criteria
March 27, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 35RC19_9784_BaBBa
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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