Clinical trials: Infant Gut Microbiome
Gastroesophageal Reflux
The Gastrointestinal Microbiome of Infants With GERD and PPI Therapy: a Pilot Study
Proton Pump Inhibitors (PPI) are standard in the therapy of pediatric GERD. In the past it has been hypothesized, that either direct inhibition of bacterial ATPase or elevation of the pH may lead to changes in the intestinal…
- Trial name
- NCT02359604
- Testing
- PPI therapy, Stool sample
- Where
- Austria
- Volunteers
- 12 people
- Sponsor
- Medical University of Graz
Severe Malnutrition, Malnutrition
Characterizing the Gut Microbiota Alteration Associated With Severe Acute Malnutrition
The investigators performed two case-control studies in Niger and Senegal analysing fecal microbiota to characterize the specificity of the gut microbiota alteration associated with severe acute malnutrition (SAM).
- Conditions
- Severe Malnutrition, Malnutrition, Infant Nutrition Disorders, Child Nutrition Disorders
- Trial name
- NCT02413905
- Testing
- Stool samples
- Where
- 2 sites in Niger, Senegal
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Institut Hospitalo-Universitaire Méditerranée Infection
Feeding Patterns, Microbial Colonization
Prephage - Faecal Bacteriophage Transfer for Enhanced Gastrointestinal Tract Maturation in Preterm Infants - Donor Study
PrePhage - Fecal bacteriophage transfer for enhanced gastrointestinal tract maturation in preterm infants This pilot triol has the primary goal of demonstrating the safety of transferring viruses and proteins from healthy term…
- Trial name
- NCT05272566
- Where
- Denmark
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Premature, Gut Microbiota Diversity and Composition
Effect of Rectal Administration of Breast Milk on Gut Microbiota in Preterm Infants
This study aims to evaluate the effect of rectal administration of maternal breast milk on gut microbiota development in preterm infants.
- Conditions
- Premature, Gut Microbiota Diversity and Composition, NEC - Necrotizing Enterocolitis
- Trial name
- premic (NCT07558499)
- Testing
- Rectal irrigation with maternal breast milk, Rectal irrigation with salin
- Volunteers
- 60 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Maternal Exposure, Health Behavior
Brain Probiotic and LC-PUFA Intervention for Optimum Early Life
Probiotics is suggested to play several roles in promoting health, including alleviating disease symptoms, protection against atopic disease, and modulating the immune system by improving the beneficial gut microbiota…
- Conditions
- Maternal Exposure, Health Behavior, Infant Development, Child Development
- Trial name
- BRAVE (NCT03851120)
- Testing
- Probiotics and LC-PUFA (480 mg DHA), Psychosocial stimulation and healthy eating education
- Where
- Indonesia
- Volunteers
- 314 people, healthy volunteers welcome
- Sponsor
- Universitas Indonesia
Infantile Colic
Lactobacillus Reuteri Versus Placebo in the Treatment and Prevention of Infantile Colic
The purpose of this study is: to study the intestinal microflora of colicky infants before and after L. reuteri or placebo administration, evaluating the effect of Lactobacillus reuteri on the growth of the main intestinal…
- Trial name
- NCT00893711
- Testing
- Lactobacillus reuteri DSM 17938, L.reuteri + Vit D
- Where
- 3 sites in Italy
- Volunteers
- 155 people
- Sponsor
- Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
Prematurity Complications
Gut Permeability and Microbiome in Preterm Infants
NEC, a life-threatening, GI emergency characterized by increased IP, affects approximately 7 to 10% of preterm neonates, and typically occurs within 7 to 14 days of birth with mortality as high as 30-50%.
- Trial name
- NCT07667049
- Testing
- measurement of intestinal permeability
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Maryland, Baltimore
Vitamin A Deficiency
Vitamin A, Stool Microbiota and Vaccine Response in Bangladeshi Infants
Vitamin A deficiency (VAD) increases the risk of death from infections in infants and young children. The World Health Organization (WHO) recommends high-dose vitamin A supplementation (VAS) from 6-59 months of age to reduce the…
- Trial name
- NCT02027610
- Where
- 3 sites in United States, Bangladesh
- Volunteers
- 258 people
- Sponsor
- USDA, Western Human Nutrition Research Center
Healthy Newborn Infants
Impact of Delivery Mode on Infant Gut Microbiota, Visceral Sensitivity, and the Neuroenteric System
The bacteria and other microorganisms that naturally live in the gut (the gut microbiome) play an important role in a baby's early development.
- Trial name
- CROSS-TIVITY (NCT07899333)
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Gut Microbiome, Mother to Child Transmission
Mother-infant Microbiota Transmission and Its Link to the Health of the Baby
The human intestinal tract harbors a diverse and complex microbial community, known as gut microbiota, which is critical in sustaining physiology, metabolism, nutrition and immune function.
- Trial name
- NCT04117321
- Where
- China
- Volunteers
- 20,000 people, healthy volunteers welcome
- Sponsor
- Chinese University of Hong Kong
Preterm Infant, Gut Microbiome
Gut Microbiota of Preterm Infants and Full-term Infants at Early Life
The aim of this study is to obtain a longitudinal view of the gut microbial establishment of a cohort of 51 preterm (PT) infants compared to 50 full-term (FT) infants from birth to 90 days of age, and to identify key clinical…
- Trial name
- NCT03373721
- Where
- China
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Crohn Disease
Mother-to-Infant Transfer of Bacteriome, Fungome, Virome, and Metabolome in Health and Crohn's Disease
Inflammatory bowel diseases (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are caused by the loss of mucosal tolerance towards the commensal microbiota resulting in inflammatory responses.
- Trial name
- NCT05112497
- Testing
- No intervention procedure
- Where
- Hong Kong
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- Chinese University of Hong Kong
Infant, Newborn, Gut -Microbiota
Infant Microbiota Restoration With Maternal Microbes
The goal of this clinical trial is to test the ability of different bacterial products in restoring natural gut microbiota in C-section born infants.
- Conditions
- Infant, Newborn, Gut -Microbiota, Gut Dysbiosis, Cesarean Delivery Affecting Newborn
- Trial name
- MaMi (NCT07212361)
- Testing
- Probiotic
- Where
- 2 sites in Finland
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Helsinki
Fecal Microflora in the Formula Fed Premature Infant
The Impact of Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Premature Infants
The purpose of this study is to see whether dietary supplements can change the germs in the intestines of premature infants to be more like those of healthy breast fed term babies.
- Trial name
- NCT00810160
- Testing
- ProlactPlus, GOS galacto-oligosaccharides, Bifidobacterium infantis
- Where
- United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
Infant Development
Interactions Between Environmental Exposures and Gut Microbiota in Early Life
Recruit the mothers and their infants who bron in Peking University People's Hospital from 2023 to 2026, to evaluate the interaction between environmental exposure and gut microbiota.
- Trial name
- NCT06479928
- Testing
- delivery mode
- Where
- China
- Volunteers
- 756 people, healthy volunteers welcome
- Sponsor
- Peking University People's Hospital
Healhty
Human Milk Oligosaccharides, Gut Bifidobacterium, Vitamin D, and Infant Immunity
The goal of this observational study is to learn how certain natural sugar components in breast milk may be linked with vitamin D level, healthy gut bacteria, and immune markers in healthy breastfed infants.
- Trial name
- HMO-BIFIDI (NCT07570329)
- Where
- Indonesia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Hasanuddin University
Atopic Dermatitis
Probiotic on Atopic Dermatitis in Infant
The clinical trial will be carried out in China Medical University Hospital. The overall plan is a double-blind trial. All recruited 3 months-3 years old atopic dermatitis (AD) patients are divided into two groups, 50 in each…
- Trial name
- NCT05286047
- Testing
- Bifidobacterium longum CCFM1029
- Where
- Taiwan
- Volunteers
- 100 people
- Sponsor
- Glac Biotech Co., Ltd
Bronchopulmonary Dysplasia
Gastrointestinal Microbiome Influence on the Development of Bronchopulmonary Dysplasia
The purpose of this study is to advance our knowledge of the factors that contribute to the development of bronchopulmonary dysplasia (BPD), a chronic lung affecting premature infants.
- Trial name
- MiBPD (NCT03229967)
- Testing
- 16S rRNA stool microbiome sequencing.
- Where
- 2 sites in United States
- Volunteers
- 197 people
- Sponsor
- University of Tennessee
Health, Children
A Study on the Changes and Prognosis of Intestinal Microbiota and Function in Infants With Food Allergies
Microorganisms maintain a complex interrelationship with the human body, influencing each other. In recent years, people have gradually realized that the formation of the pediatric microecosystem is closely related to the…
- Conditions
- Health, Children, Gut Microbiota
- Trial name
- NCT06854536
- Where
- China
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Ruijin Hospital
Infantile Colic, Gastroesophageal Reflux (GER)
BioAmicus Complete for Functional Gastrointestinal Symptoms in Infants Aged 0 to 24 Months
Infants often experience functional gastrointestinal symptoms (e.g., colic, excessive gas, regurgitation, constipation, or loose stools) that distress families and may reflect an imbalance of the gut microbiome.
- Conditions
- Infantile Colic, Gastroesophageal Reflux (GER), Functional Constipation, Functional Diarrhea
- Trial name
- CTBE2503 (NCT07148583)
- Testing
- BioAmicus Complete, Usual Care (No Probiotic)
- Where
- Vietnam
- Volunteers
- 110 people
- Sponsor
- Haiphong University of Medicine and Pharmacy