Bern Birth Cohort Study on Microbiota Maturation in Healthy Infants Using a Network Approach
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2024-11-12
250
Participants Needed
1
Research Sites
365 weeks
Total Duration
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I
Insel Gruppe AG, University Hospital Bern
Lead Sponsor
U
University of Bern
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how the intestinal microbiota develops in healthy infants during their first two years of life and beyond. This study focuses on understanding the composition, diversity, and metabolic activity of gut bacteria in infants, as well as how factors like maternal microbiota and the environment affect this development. The goal is to learn how the maturation of the microbiota influences infant growth, immune system development, and potential health issues such as abdominal pain.
The study will follow 250 pregnant women and their babies from the 20th week of pregnancy until the children reach 10 years old. Researchers will collect and analyze various biological samples, including infant stool, maternal milk, vaginal and skin swabs, to study bacterial species and their metabolic functions using advanced sequencing and mass spectrometry techniques. The study will also assess infant nutrition, hygiene, socioeconomic factors, and clinical outcomes at regular visits.
Participants will be monitored through clinical evaluations, questionnaires, and biological sample collection at multiple time points from birth up to 10 years. The primary outcomes focus on changes in the complexity and activity of the infant gut microbiota at specific intervals after birth. Secondary outcomes include assessing environmental impacts, maternal bacterial transfer, and effects on child development. Any important health findings will be shared with participants and their doctors, and participants can opt out of human DNA analysis without affecting their involvement.
CONDITIONS
Brief Title
Bern Birth Cohort / Trajectory of Microbiota Maturation in Healthy Bern Infants - a Network Approach
Who Can Participate
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
Signed informed consent.
Ability to understand and follow study procedures and understand informed consent.
Pregnant from week 20 until birth.
General good health without major severe medical, surgical, or psychiatric conditions requiring ongoing management.
Minor well-controlled conditions such as medically managed hypertension, occupational asthma, or gestational diabetes are allowed.
Absence of known severe embryonal pathology; expected normal pregnancy including minor conditions like twin or triplet pregnancy or final pelvic position.
Age between 18 and 45 years.
Female gender.
You will not qualify if you...
Participation in another clinical study that interferes with the procedures of this study.
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - From birth up to 10 years after birth
Participants provide infant stool samples and other biological samples at scheduled times to observe the maturation of the infant intestinal microbiota and its impact on child development and health. Questionnaires about nutrition, hygiene, socioeconomic status, and clinical history are completed at each visit.
The Bern Birth Cohort (BeBiCo) to study the development of the infant intestinal microbiota in a high-resource setting in Switzerland: rationale, design, and methods.
Luca Cecchini, Colette Barmaz, Maria José Coloma Cea...