Clinical trials: Infant Gut Microbiome
Microbiota
Effect of Intrapartum Antibiotic Prophylaxis (IAP) on the Development of the Neonatal Gut Microbiota.
The colonization of the neonatal gastro-intestinal (GI) tract begins at birth and is influenced by several factors, such as mode of delivery, gestational age, maternal intestinal and vaginal microbiota, type of feeding…
- Trial name
- MICROBIOTA-SO (NCT02212002)
- Testing
- IAP
- Where
- Italy
- Volunteers
- 84 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Severe Infection and Non-injury Death
SEPSIS Observational Cohort Study in Young Infants in Bangladesh
Globally, infectious diseases such as sepsis, meningitis and pneumonia are among the leading causes of neonatal deaths. A recent observational study in South Asia highlighted the contribution of both bacterial and viral…
- Trial name
- NCT04012190
- Where
- 2 sites in Bangladesh
- Volunteers
- 2,083 people, healthy volunteers welcome
- Sponsor
- The Hospital for Sick Children
Gut -Microbiota, Inflammatory Markers
Walnuts as an Infant Solid Food for Health
The objective is to investigate the effect of walnuts on gut microbiota, inflammatory markers, atopic dermatitis status, and indices of allergy outcomes in breastfed infants during early complementary feeding.
- Conditions
- Gut -Microbiota, Inflammatory Markers, Infant Development
- Trial name
- WISH (NCT07081698)
- Testing
- Infant walnut intake
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Colorado State University
Healthy Infants
Efficacy of Two HMOs in Chinese Infants
This is a randomized, controlled, double-blind, intervention trial of healthy male and female term infants to evaluate the efficacy of the 2 HMOs on beneficially modulating the gut microbiota, gut maturation, gut barrier…
- Trial name
- NCT06361719
- Testing
- Experimental Group (EG), Control Group (CG)
- Where
- China
- Volunteers
- 262 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Microbial Colonization, Microbial Superinvasion
Metagenomic Analysis of Gut Microbiome in Preterm
This is single center study. The investigators will try to know that relationships between intestinal microbiome and mortality in preterm infants and what relationships is between intestinal microbiome in preterm infants and…
- Conditions
- Microbial Colonization, Microbial Superinvasion, Microbial Substitution, Newborn Morbidity
- Trial name
- MAGMP (NCT03235635)
- Where
- South Korea
- Volunteers
- 120 people
- Sponsor
- Wonju Severance Christian Hospital
Microbial Colonization
Probiotics and Intestinal Microbiome in Preterm Infants
The gut microbiome plays a significant role in balancing the inflammatory system in the immature gut. A breakdown in this balance with altered colonization of the microbiota in very low birth weight (VLBW) preterm infants is…
- Trial name
- NCT03422562
- Testing
- Florababy
- Where
- Canada
- Volunteers
- 62 people
- Sponsor
- Belal Alshaikh
Metabolic Dysfunction-Associated Steatotic Liver Disease Infant Development
TUDCA in High-Risk Lactating Mothers Identified by Early Postpartum Milk Hydrophobicity Index
This is a randomized, double-blind, placebo-controlled Phase 2 proof-of-concept trial in mother-infant dyads. The study aims to evaluate the safety, tolerability, and biological effects of maternal oral tauroursodeoxycholic acid…
- Trial name
- MILK-HI-TUDCA (NCT07517276)
- Testing
- tauroursodeoxycholic acid (TUDCA)
- Volunteers
- 80 people
- Sponsor
- Peking University First Hospital
Preterm Birth
Impact of Dietary Sodium Supplementation on Growth & Intestinal Microbiome
The purpose of this project is to determine the direct impact of sodium supplementation in preterm infants and to see the overall improvement of their growth and health status.
- Trial name
- NCT05546814
- Testing
- Sodium algorithm
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Medical College of Wisconsin
Bacterial Infections
Changes in Microbiota and Iron Status After Iron Fortification of Complementary Foods
Infants and children under two years are the group with the highest rates of iron deficiency anemia. Provision of sufficient dietary iron to this age group is a challenge, and in-home iron fortification of complementary foods…
- Trial name
- NCT01111864
- Testing
- fortification with iron and micronutrients, Sprinkles
- Where
- Kenya
- Volunteers
- 160 people
- Sponsor
- Swiss Federal Institute of Technology
Diet, Healthy, Infant Development
The Motility Mother-Child Cohort
The overall aim of the project is to investigate how bowel habits and nutrition in early life relate to the infant gut microbiome and metabolome from birth to 1 year of age.
- Trial name
- MOTILITY (NCT05491161)
- Testing
- Longitudinal study
- Where
- Denmark
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- University of Copenhagen
Colic, Infantile, Probiotic
NEOBIFI: Clinical Trial for the Prevention and/or Reduction of the Incidence of Colics in Infants
Infant colics represent a clinical condition in childhood, characterized by an uncontrollable crying that occurs without any apparent organic cause.1 They can be associated with face redness, closed fists, thighs flexion…
- Conditions
- Colic, Infantile, Probiotic, Gut Microbiome, Bifidobacterium Breve
- Trial name
- NEOBIFI (NCT03219931)
- Testing
- Bifidobacterium breve BR03 and Bifidobacterium breve B632
- Where
- Italy
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
Malnutrition (Calorie), Infant Nutrition Disorder
Goat Milk-Derived Formula vs. Undiluted Goat Milk in Infants Unable to Exclusively Breastfeed: Growth and Biomarker Analysis
The goal of this clinical trial is to learn if Goat Milk-Derived Formula Alternatives (GMDFA) are safe and effective for infants who are unable to be exclusively breastfed.
- Conditions
- Malnutrition (Calorie), Infant Nutrition Disorder, Growth Flatering, Gut Microbiome
- Trial name
- GMDFA (NCT07225153)
- Testing
- GMDFA, Undiluted Goat Milk
- Where
- Pakistan
- Volunteers
- 15 people
- Sponsor
- Aga Khan University
Gut Microbiota and Sleep in Infants
Infant Sleep Behaviour and Gut Microbacteria
The overarching study aim is to evaluate the development of sleep behavior and gut microbiota (GMB), and their potential interaction, during the vulnerable period of the first year of life.
- Trial name
- SDEGU (NCT02836119)
- Where
- Switzerland
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- University of Zurich
Cystic Fibrosis
Probiotics on Intestinal Inflammation 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
- NCT01961661
- Testing
- Lactobacillus rhamnosus GG
- Where
- Italy
- Volunteers
- 22 people
- Sponsor
- Federico II University
Human Gut Microbiome Development
Phages Dynamics and Influences During Human Gut Microbiome Establishment
Microbial communities are key components of human environment. Consequently, human gut microbiome have been extensively studied providing a better understanding of the relations between bacterial populations and host physiology.
- Trial name
- METAKIDS (NCT03296631)
- Testing
- collection of diapers with fresh stools
- Where
- 2 sites in France
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Cow's Milk Protein Allergy (CMPA), Food Hypersensitivity
SMASH: Study to Evaluate the Clinical Efficacy of an Extensively Hydrolysed Infant Formula With Synbiotics and a Human Milk Oligosaccharide (HMO) in Infants With Cow's Milk Protein Allergy (CMPA)
Cow's milk protein allergy (CMPA) is one of the most common food allergies in infants, with an estimated prevalence between 2% and 5%.
- Conditions
- Cow's Milk Protein Allergy (CMPA), Food Hypersensitivity, Infant Nutrition Disorders, Gut Microbiota
- Trial name
- SMASH (NCT07342621)
- Where
- 13 sites in Spain
- Volunteers
- 41 people
- Sponsor
- Outcomes'10
Intestinal Microbiome
Cesarean Section and Intestinal Flora of the Newborn
Mode of delivery affects gut microbiome of the infant. Infants born by caesarean section have a less heterogenous microbiome for the first weeks of life.
- Trial name
- SECFLOR (NCT03568734)
- Testing
- Fecal transplant
- Where
- Finland
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Sture Andersson
Healthy Infants
Probiotic for Infants
The BABIES II study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with an 8½ months intervention period from 14 days of age to 9 months of age followed by a 3-months short-term follow-up…
- Trial name
- BABIES II (NCT07054216)
- Testing
- Probiotic
- Where
- 2 sites in Denmark
- Volunteers
- 378 people, healthy volunteers welcome
- Sponsor
- Hvidovre University Hospital
Streptococcus Mutans
Investigation of Oral Microflora of Infants
The placement of cariogenic microorganisms in oral microflora is an important factor in dental caries. The aim of this study is to research from whom, when and how the cariogenic microorganisms are first transmitted to the…
- Trial name
- NCT04228861
- Where
- Turkey (Türkiye)
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Inonu University
Microbiota, Eczema
Infant Restore: Efficacy of Microbiome Analysis and Education
The goal of this clinical trial is to learn if a microbiome analysis, education, and recommendation program can improve gut health, reduce future health risks, and empower parents in their children's health in infants aged 0-3…
- Conditions
- Microbiota, Eczema, Microbiome, Gut Microbiome
- Trial name
- NCT06424691
- Testing
- Tailored Recommendations, Consult Call, Email Series
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Seeding Inc