Study of Intestinal Microbiota Development in Healthy Infants and Mothers in Bern
Tracking Microbiota Changes and Their Effects up to 10 Years of Age
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2024-11-12
250
Participants Needed
1
Research Sites
365 weeks
Total Duration
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
Research Team
B
Benjamin Misselwitz, Professor
S
Stephanie Ganal-Vonarburg, Professor
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
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.
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.
Approximately 11 visits over 10 years
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Testing a Smartphone-Based Support Platform to Reduce Suicide Risk in Teens Aged 13 to 18 Receiving Intensive Outpatient Treatment
Comparing ViraSafe and BRITE Apps to Improve Suicide Safety Planning in Youth Aged 13 to 24
Parent-to-Child Nasal Microbiota Transplant to Restore Infant Nasal Bacteria After Mupirocin Treatment for Staphylococcus Aureus Colonization
Study of the Ocular Microbiome in Eye Health and Various Eye Diseases including Glaucoma and Macular Degeneration
Early-Life Bifidobacterium Infantis Supplementation to Boost Immunity in Infants Exposed to HIV
A Randomized, Double-Blind, Placebo-Controlled Trial
Study of Intestinal Microbiota Development in Healthy Infants and Mothers in Bern
Tracking Microbiota Changes and Their Effects up to 10 Years of Age
Broad-spectrum Antibiotic Use to Prevent Infection in Tumor and Infected Orthopedic Surgery
A Phase 3 Randomized Study Comparing Standard and Additional Vancomycin-Gentamicin Prophylaxis
Study of Changes in Bile Acid Profile and Gut Microbiota in Adults Treated with Bulevirtide for Hepatitis Delta Virus Infection
Study of Oral Microbiome Changes from Having Teeth to Tooth Loss and After Dental Implant Placement in Adults with Severe Periodontitis
Collection of Skin, Oral, Vaginal, and Fecal Microbiome Samples from Healthy Western Donors
for Basic Microbiome Research at Ghent University
Have more questions? Get in touch with our team for quick support
Published Research Related To This Trial
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...