Bern Birth Cohort / Trajectory of Microbiota Maturation in Healthy Bern Infants - a Network Approach
NCT04447742 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 250
Last updated 2024-11-12
Summary
Background: Intestinal microbiota composition is fundamental to human health and undergoes critical changes within the first two years of life. Factors probably influencing the microbiota are the maternal microbiota and the general environment in Switzerland. However, the development of the intestinal microbiota is incompletely understood. Gaining knowledge of the trajectory of microbiota maturation is likely key to the understanding of the pathogenesis of many pathologies in childhood.
Aims: The investigators aim for a deep understanding of the maturation of the healthy infant intestinal microbiota regarding composition, diversity and metabolic activities. The investigators aim for identifying parameters affecting microbiota maturation and effects of the microbiota on infant outcome.
Methods: The investigators will recruit 250 pregnant mothers who will be followed as mother-baby pairs until 10 years of age. Infants will be followed clinically to determine adequate growth and development as well as pathology including abdominal pain. Epidemiological parameter and infant nutrition will be assessed. The investigators will collect biological samples such as stool, maternal milk, vaginal swaps and skin swaps.
Species composition and diversity will be assessed by 16S sequencing. Metagenomic shotgun sequencing and bacterial messenger ribonucleic acid (mRNA) analysis will inform about metabolic potential and metabolic activity of the microbiota. Mass spectrometry will assess the small molecule content of stool and maternal milk samples. Network analysis will be used to assess the complex relationships between bacteria metabolic activities and small molecular content.
Expected results: The investigators expect an increase in complexity and metabolic potential and activity with age. Microbiota parameters will differ according to nutrition and might predict infant outcomes such as growth and abdominal pain. Systematic analysis of sequential maternal and infant bacteria samples from stool, skin and maternal milk will help characterizing bacterial transfer from mother to infant Conclusion: The investigators propose an observational study of healthy Bern mother baby pairs with clinical characterisation and biological sampling. Advanced analysis tools will be used to characterise the microbiota and address mechanistic questions.
Conditions
- Maturation of the Healthy Infant Intestinal Microbiota
- Microbial Colonization
- Nutrition Disorder, Infant
- Milk Expression, Breast
- Mental Health Disorder
Sponsors & Collaborators
-
University of Bern
collaborator OTHER -
Insel Gruppe AG, University Hospital Bern
lead OTHER
Principal Investigators
-
Benjamin Misselwitz, Professor · University Hospital of Bern - Insel Spital
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-05-07
- Primary Completion
- 2028-03-03
- Completion
- 2035-03-03
Countries
- Switzerland
Study Locations
More Related Trials
-
The Development and Health of the Intestinal Flora During the First Year of Life
NCT06285630 ·Status: ENROLLING_BY_INVITATION
-
The Influence of Feeding Source on the Gut Microbiome and Time to Full Feeds in Neonates With Congenital Gastrointestinal Pathologies
NCT06072976 ·Status: RECRUITING ·Phase: NA
-
The Alberta BLOOM Preterm Neonate Study
NCT03840980 ·Status: TERMINATED
-
Feeding the Preterm Gut Microbiota - Impact of Infant-feeding on Preterm Gut Microbiota Development
NCT03663556 ·Status: UNKNOWN
-
Influence of Intestinal Microbiota Implantation in Preterm Infants on Microbiota and Immune Orientation at 3 Years
NCT02738411 ·Status: ACTIVE_NOT_RECRUITING
-
The Intestinal Innate Immune System in Newborns. Development and Inflammation in Health and Disease
NCT06092463 ·Status: RECRUITING
-
BM Collection From NICU Infants for Composition
NCT02570698 ·Status: COMPLETED
-
Ex Vivo Exploratory Analysis in Healthy Full-term Infants
NCT01573884 ·Status: COMPLETED
-
Breastfeeding Study
NCT03387124 ·Status: COMPLETED
-
Gut Microbiota of Preterm Infants and Full-term Infants at Early Life
NCT03373721 ·Status: RECRUITING
-
Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas
NCT04059666 ·Status: TERMINATED ·Phase: NA
-
Efficacy of a New Infant Formula Composition on Gut Health in Infants
NCT07242508 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Gut Bacteria and Brain of the Baby
NCT04432636 ·Status: RECRUITING ·Phase: NA
-
The Influence of Infant Feeding Type on Preterm Infant's Intestinal Microbiome
NCT04972214 ·Status: UNKNOWN
-
Enteral Feeding and Early Gut Colonization of Preterm Infants
NCT02502916 ·Status: COMPLETED
-
An Examination of Infants' Microbiome, Nutrition, and Development Study.
NCT03229863 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Early Iron Exposure on the Gut Microbiota in Young Infants
NCT03828708 ·Status: UNKNOWN ·Phase: NA
-
Intestinal Genes Expression Associated With Necrotizing Enterocolitis
NCT04073342 ·Status: UNKNOWN
-
Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula
NCT01370967 ·Status: COMPLETED
-
Probiotics and Early Microbial Contact in Preterm Neonates
NCT01454661 ·Status: UNKNOWN ·Phase: NA
-
Probiotics Supplementation in Premature Infants
NCT01379417 ·Status: COMPLETED ·Phase: NA
-
Neonatal Microbiome Validity Study
NCT02655250 ·Status: COMPLETED
-
Impact of Infant Feeding on Newborn Metabolomic Profile
NCT01606683 ·Status: COMPLETED ·Phase: NA
-
The Role of Human Milk in Development of Breast Fed Child's Intestinal Microbiota
NCT01548313 ·Status: COMPLETED
-
Efficacy of a Dietary Supplement in Infants
NCT07341477 ·Status: NOT_YET_RECRUITING ·Phase: NA