Clinical trials: Infant Gut Microbiome
Gut Microbiota, Gastrointestinal Symptoms
Mother-Infant Cohort Study in Malaysia and China
This mother-infant cohort study aims to determine the geographic differences in the microbial profiles in breast milk from mothers living in Malaysia and China that are potentially important determinants of infant development.
- Conditions
- Gut Microbiota, Gastrointestinal Symptoms, Temperament, Eczema
- Trial name
- NCT04919265
- Testing
- No intervention - mother-infant cohort study
- Where
- Malaysia
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Universiti Putra Malaysia
Infant Colic, Gut Microbiota
Effect of a Dietary Supplement vs Low-dosage Product on Infant Gastrointestinal Discomfort and Colics
The goal of this clinical trial is to verify whether a food supplement is effective in treating infantile colic of infants aged between 21 days and 9 months and the colonization ability of the gut microbiota by measuring faecal…
- Trial name
- DISIC (NCT07017244)
- Testing
- Verum, Active comparator
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Breastfeeding
Effects of 5-Methyltetrahydrofolic Acid Supplementation on Maternal Health and One-Carbon Metabolism During Lactation
This double-blind, randomized, placebo-controlled parallel trial evaluates the effects of maternal 5-methyltetrahydrofolate (5-MTHF) supplementation during breastfeeding.
- Trial name
- OCMS (NCT07508917)
- Testing
- 5-MTHF Supplementation
- Where
- 2 sites in Spain
- Volunteers
- 36 people
- Sponsor
- Fundació Sant Joan de Déu
Gastrointestinal Diseases, Colic
Effect of Lactobacillus Reuteri DSM17938 in Neonates Treated With Antibiotics
The aim of the study is to elucidate the relationship between postnatal antibiotic administration on development of gut microbiota and possible protective influence of simultaneously administration of probiotic during antibiotic…
- Trial name
- NCT02865564
- Testing
- Lactobacillus reuteri DSM 17938, ampicillin and gentamicin
- Where
- Slovenia
- Volunteers
- 98 people
- Sponsor
- University Medical Centre Ljubljana
Eczema, Allergy
Probiotics in Prevention of Allergies, Obesity and Caries
During the period of 2000-2003, 179 healthy, term infants with no previous signs of allergic disease were recruited and randomized to daily intake of cereals with or without the addition of Lactobacillus paracasei subspecies…
- Conditions
- Eczema, Allergy, Asthma, Obesity
- Trial name
- ELEFANT (NCT00894816)
- Testing
- Lactobacillus F19
- Where
- Sweden
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Umeå University
Dysbiosis, Prophylaxis
Lactobacillus Reuteri DSM 17938 in Gut Microbiota Development in Infant Born by Caesarean Section
The aim of this study is to assess influence of probiotic Lactobacillus reuteri DSM 17938 on formation of gut microbiota in infant born by Caesarean section.
- Trial name
- NCT03675048
- Testing
- BioGaia Protectis drops
- Where
- Russia
- Volunteers
- 97 people
- Sponsor
- BioGaia AB
Maturation of the Healthy Infant Intestinal Microbiota, Microbial Colonization
Bern Birth Cohort / Trajectory of Microbiota Maturation in Healthy Bern Infants - a Network Approach
Background: Intestinal microbiota composition is fundamental to human health and undergoes critical changes within the first two years of life.
- Conditions
- Maturation of the Healthy Infant Intestinal Microbiota, Microbial Colonization, Nutrition Disorder, Infant, Milk Expression, Breast
- Trial name
- BeBiCo (NCT04447742)
- Where
- Switzerland
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Growth Failure, Preterm Birth
Impact of Colostrum Oropharyngeal Immunotherapy on Postnatal Growth in Preterm Infants
The goal of this clinical trial is to ascertain whether oropharyngeal administration of colostrum contributes to postnatal growth in very preterm infants (those born before 32 weeks of gestation).
- Conditions
- Growth Failure, Preterm Birth, Microbiota
- Trial name
- IOCOIOPGIPI (NCT07082881)
- Testing
- Colostrum, Normal Saline
- Volunteers
- 220 people
- Sponsor
- Suqian First Hospital
Necrotizing Enterocolitis, Bronchopulmonary Dysplasia
A Cohort Study of the Intestinal Microbiota of Premature Infants
Premature infants are at risk for a variety of diseases, the investigators would like to learn more about why some premature babies are at higher risk and some are protected from these diseases.
- Conditions
- Necrotizing Enterocolitis, Bronchopulmonary Dysplasia, Growth Failure
- Trial name
- NCT03717584
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- University of California, Davis
Immunity
A Clinical Study to Investigate the Effect of a Partially Hydrolysed Infant Formula With Added Synbiotics on Gut Microbiota Composition and Clinical Effectiveness in Infants at High Risk of Developing Allergy
With the rising prevalence of allergic diseases and the subsequent risk of developing other immune-related disorders, primary prevention of allergy has become a major priority.
- Trial name
- TEMPO (NCT03067714)
- Testing
- Infant formula with added synbiotics, Standard infant formula
- Where
- 59 sites in Belgium, Czechia and 11 more
- Volunteers
- 855 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Gastrointestinal Microbiome
A Cohort Analysis Study of Intestinal Flora in Infants
The purpose of this study is to investigate the influence factors of gastrointestinal microbiome in infants.
- Trial name
- NCT03396198
- Where
- China
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Mizu Jiang
Microbial Colonization
Comparing Impacts of Donor Human Milk to Formula Supplementation on the Gut Microbiome of Full-term Infants
The goal of this pilot randomized controlled trial (RCT) is to examine donor human milk (DHM) as a clinical intervention targeted at achieving beneficial microbiome signatures in full-term infants who are exposed to intrapartum…
- Trial name
- PPDHM (NCT05815433)
- Testing
- Donor Human Milk - Nutritional Replacement
- Where
- Canada
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- University of Calgary
Preterms With Gestational Age Ranging From 30 to 35 Weeks
Evaluation of Safety, Tolerance and Effects on the Intestinal Flora of a New Fermented Milk for Preterm Infants
The intestinal flora is a complex ecosystem which is known to play various important functions in the gut. Recent data have reported a delay in intestinal colonization in preterm.
- Trial name
- NCT00711633
- Testing
- Milk with probiotic and prebiotic activities, Milk without probiotic and prebiotic activities
- Where
- France
- Volunteers
- 58 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Very Preterm Infants
Feeding the Preterm Gut Microbiota - Impact of Infant-feeding on Preterm Gut Microbiota Development
Preterm infants are especially vulnerable to gut microbiota disruption and dysbiosis since their early gut microbiota is less abundant and diverse.
- Trial name
- FEEDMI (NCT03663556)
- Testing
- Infant-feeding
- Where
- 2 sites in Portugal
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Universidade do Porto
Digestion, Gut Microbiota
Feeding Tolerance and Gut Maturation of Infants Consuming a Formula Rich in Glycoprotein
This is a non-randomized, single-arm, open-label, prospective interventional study using a commercially available starter infant formula in healthy term formula-fed infants with a parallel group of healthy term breast-fed infants…
- Trial name
- NCT04880083
- Testing
- Commercially Available Starter Infant Formula
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Sleep Problem, Neurobehavioral Manifestations
NapBiome: Targeting Gut Microbiota and Sleep Rhythm to Improve Developmental and Behavioral Outcomes in Early Childhood
The gut-brain axis plays a crucial role in the regulation and development of psychological and physical processes. The first year of life is a critical period for the development of the gut microbiome, which parallels important…
- Trial name
- NapBiome (NCT06396689)
- Testing
- Synbiotic
- Where
- 2 sites in Switzerland
- Volunteers
- 380 people, healthy volunteers welcome
- Sponsor
- Petra Zimmermann
Celiac Disease
Celiac Disease Genomic Environmental Microbiome and Metabolomic Study
Celiac disease (CD) is a complex disease caused by eating gluten, a protein contained in wheat, rye, and barley. It is well known that many factors contribute to the development of CD, including the genes that you have and the…
- Trial name
- CDGEMM (NCT02061306)
- Where
- 2 sites in United States, Italy
- Volunteers
- 500 people
- Sponsor
- Massachusetts General Hospital
Infant Development
Early Iron Exposure on the Gut Microbiota in Young Infants
This study will look at the amount of iron in infant formula and how that affects a child's gut development. The children of mothers who plan to formula feed their children will be randomized to receive either high iron or low…
- Trial name
- IF (NCT03828708)
- Testing
- Iron in infant formula
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Prebiotics, Honey
Medically-Graded Honey Supplementation Formula To Preterm Infants
Honey is a natural product that contains multiple nutrients; it is composed of fructose, glucose and fructooligosaccharides that can potentially serve prebiotic functions.
- Conditions
- Prebiotics, Honey, Premature Infants, Intestinal Microbiota
- Trial name
- Honey (NCT02679183)
- Testing
- Medically-Graded Honey, Premature Milk Formula
- Volunteers
- 40 people
- Sponsor
- Cairo University
Gut Microbiome, Neurocognitive Correlates of Eating Habits
Tiny Tummies - A Milk Study
This is a 12-month, 2-arm randomized controlled trial (n=150) examining whether toddlers randomized at 12 months of age to 1.5 cup-equivalents/day of cow's milk-based dairy versus oat milk-based dairy, and followed to 24 months…
- Conditions
- Gut Microbiome, Neurocognitive Correlates of Eating Habits, Infants and Young Children, Sleep
- Trial name
- NCT07839156
- Testing
- Daily cow's milk products, Daily Oat Milk Exposure
- Where
- United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Arizona State University