Clinical trials: Infant Gut Microbiome
Necrotising Enterocolitis, Late-Onset Neonatal Sepsis
Characterization of Intestinal Microbiota Stability in Preterm Born Neonates
Study around very-low birthweight preterm infants at high risk of developing necrotizing enterocolitis (NEC) or late-onset sepsis (LOS).
- Trial name
- NEC (NCT04792918)
- Where
- 2 sites in Switzerland
- Volunteers
- 81 people
- Sponsor
- Emma Marie Caroline Slack
Infant Development
Blueberry Intake and Infant Gut Health
The objective of this project is to investigate the effects of blueberries on gut microbiota, inflammation and innate immunity in breastfed infants during early complementary feeding (~5 to 12 months of age).
- Trial name
- NCT05006989
- Testing
- Blueberry Powder
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Diarrhea, Atopic Dermatitis
Cesarean Section Study
Effect, tolerance and safety of a supplementation with a probiotic on the risk of gastrointestinal infections, on growth, and on gut microbiota in healthy newborn term infants born by Cesarean section.
- Trial name
- NCT01992497
- Testing
- Probiotic
- Where
- Germany
- Volunteers
- 721 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Healthy Infants
HMOs on Infant Gut Microbiota Modulation and Development of the Immune System in Healthy Infants
The goal of this clinical trial is to learn how a mixture of human milk oligosaccharides impacts the development of the infant microbiota, the immune maturation and how the interaction between the microbiota and immune maturation…
- Trial name
- BELIEF (NCT06631937)
- Testing
- Human Milk Oligosaccharides
- Where
- 2 sites in Denmark
- Volunteers
- 334 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Microbial Colonization
Preterm Infant Intestinal Microbiota Development and Maternal Fecal Transplant
The goal of this clinical trial is to study if a oral maternal fecal transplant given to a premature infant born by cesarean section (CS) is safe.
- Trial name
- PREFLOR (NCT06227845)
- Testing
- Fecal microbiota transplant
- Where
- Finland
- Volunteers
- 36 people
- Sponsor
- Otto Helve
Functional Constipation in Children
Effect of Probiotic on Gut Microbiota in Young Children With Functional Constipation
This study was a 28-day, open-label, randomized controlled trial involving infants and toddlers diagnosed with functional constipation. Participants were randomized to receive either Bifidobacterium longum subsp.
- Trial name
- NCT07360535
- Testing
- Probiotic, Lactulose Oral Liquid Product, probiotic + lactulose
- Where
- 2 sites in China, Malaysia
- Volunteers
- 84 people
- Sponsor
- Min-Tze LIONG
Very Low Birth Weight Baby, Premature Birth
Human-derived Human Milk Fortifiers (H2MF), Gut Microbiota and Oxidative Stress in Premature Infants
This is a randomized controlled trial of a human-derived human milk fortifier (H2MF) vs standard bovine-derived human milk fortifier (HMF) evaluating fecal microbiota and fecal and urinary biomarkers of oxidative stress in…
- Conditions
- Very Low Birth Weight Baby, Premature Birth, Microbial Colonization, Oxidative Stress
- Trial name
- NCT03214822
- Testing
- H2MF
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- University of Manitoba
Obesity, Childhood
GI Tract Biomarkers in Infants With Different Diets
Childhood obesity is increasing with more than one-third of adolescents currently overweight and one in five with obesity. The lifelong incidence of obesity-related morbidities is also increasing with childhood obesity.
- Trial name
- NCT03751137
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Nemours Children's Clinic
Microbial Colonization, Antibiotic Side Effect
Timing of Maternal Antibiotic Prophylaxis During a Cesarean Section and the Early Infant Gut Microbiome
In this study, investigators seek to determine whether the timing of antibiotics given to mothers during an elective C-section affects the composition of their infant's gut microbiome.
- Conditions
- Microbial Colonization, Antibiotic Side Effect, Cesarean Section Complications
- Trial name
- CSBabyBiome (NCT06030713)
- Testing
- Cefazolin
- Where
- Netherlands
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- University Medical Center Groningen
Infant Formula Intolerance, Well-being
Efficacy of JINLINGGUAN and TOFER Formula in Formula-fed Chinese Term Infants
Objective：The present trial aimed to assess efficacy and safety of Jin Ling Guan and Tofer infant formula on body growth, intestinal tolerance, gut microbiota and fecal residual nutrients as compared to breast-milk in term…
- Trial name
- NCT03178474
- Testing
- JINLINGGUAN Infant formula,PRO-KIDO™ I-PROTECH®, TOFER Infant formula,TOFER®, Breast milk
- Where
- 3 sites in China
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Sun Yat-sen University
Cystic Fibrosis
Probiotics in Cystic Fibrosis
Cystic fibrosis (CF) is a complex systemic disease that mainly involves the respiratory and gastrointestinal (GI) tracts. The polymicrobial community composition of respiratory and GI tracts is influenced by both genetic and…
- Trial name
- NCT01956916
- Testing
- Lactobacillus rhamnosus GG
- Where
- 5 sites in Italy
- Volunteers
- 110 people
- Sponsor
- Federico II University
Short Bowel Syndrome, Complications
Intestinal Microbial Dysbiosis in Chinese Infants With Short Bowel Syndrome With Different Complications
There are no reports involved the intestinal microbiota from Chinese infants with short bowel syndrome (SBS) under different clinical status.
- Trial name
- MSBS (NCT02699320)
- Testing
- Complications
- Where
- China
- Volunteers
- 33 people
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Premature Infants
Development of Preterm Infant Gut Microbiome
This study aims to explore the developmental of the gut microbiome in preterm infants as they grow and mature
- Trial name
- NCT03552952
- Testing
- No intervention
- Where
- Israel
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Rambam Health Care Campus
Infantile Colic
Combined Probiotics is More Effective in the Treatment of Infantile Colic
All participants are randomized into 1 of 3 treatment arms, the mixture L acidophilus, B longum and B. bifidum group, Lactobacillus reuteri or placebo group.
- Trial name
- NCT03877458
- Testing
- L. acidophilus TYCA06, B. longum BLI-02 and B. bifidum VDD088, L. reuteri GL-104
- Where
- Taiwan
- Volunteers
- 99 people
- Sponsor
- China Medical University Hospital
Prematurity, Intestinal Permeability
Intestinal Permeability in Preterm Infants
Necrotizing enterocolitis (NEC) is a life-threatening, gastrointestinal emergency characterized by increased intestinal permeability, affects approximately 7 to 10% of infants <1500 g birthweight, and typically occurs within 7 to…
- Trial name
- IPPI (NCT01756040)
- Testing
- Lactulose -rhamnose solution
- Where
- United States
- Volunteers
- 211 people
- Sponsor
- University of Maryland, Baltimore
Exposures Associated With Pregnancy, Delivery and Lactation
Impact of Perinatal Exposure to Non-caloric Sweeteners on Food Preferences and Weight Gain in the First Year of Life
During last years, non-caloric sweeteners (NCSs) have been increasingly incorporated into foodstuffs in replacement of sucrose in Chile.
- Trial name
- NCT03972176
- Volunteers
- 315 people, healthy volunteers welcome
- Sponsor
- University of Chile
Cows Milk Allergy
Synbiotics Cohort Study
Observational study exploring the clinical outcomes of infants with cow's milk allergy who are prescribed a hypoallergenic formula containing synbiotics.
- Trial name
- NCT05046418
- Testing
- Hypoallergenic formula containing synbiotics
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Nutricia UK Ltd
Irritable Bowel Syndrome
Effect of Curcumin on Gut Microbiota in IBS
To evaluate the effect of curcumin food supplement on gut microbiota of children with irritable bowel syndrome (IBS) and to review any correlation between the changes in the microbiota with symptoms.
- Trial name
- NCT03568513
- Testing
- Curcumin
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Medical College of Wisconsin
Mental Health Wellness
Study of Probiotic Use After Childbirth in Relation to Emotional Well-Being
Researchers at Massachusetts General Hospital are interested in learning more about the neurobiology of well-being in new mothers and novel ways to support them during their transition to parenthood.
- Trial name
- PACE (NCT04472065)
- Testing
- Lactobacillus reuteri
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Elizabeth Austen Lawson
Infant, Premature, Diseases, Infant
The Alberta BLOOM Long Term Follow Up Study
This is a prospective, observational clinical cohort study involving children born very preterm at less than 31 weeks and six days gestation.
- Conditions
- Infant, Premature, Diseases, Infant, Asthma, Asthma in Children
- Trial name
- BLOOM-LTFU (NCT04641000)
- Where
- Canada
- Volunteers
- 15 people
- Sponsor
- University of Calgary