Clinical trials: Infant Gut Microbiome
Gastrointestinal Microbiome
Shanghai Infants Gut Microbiome Associated Study
The purpose of this study is to evaluate the effect of probiotics on the gut microbiome of infants treated with antibiotics.
- Trial name
- NCT03388112
- Testing
- Probiotics
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Shanghai 10th People's Hospital
Premature Birth, Neurodevelopmental Disorders
Probiotics Supplementation for Neurodevelopment in Preterm Infants
The purpose of this randomized controlled trial is to evaluate the effect of daily supplementation with a probiotic mixture on the neurodevelopmental outcomes of preterm infants with a history of neonatal antibiotic exposure.
- Conditions
- Premature Birth, Neurodevelopmental Disorders, Dysbiosis
- Trial name
- NCT07617181
- Testing
- Probiotic Mixture (Bifidobacterium animalis subsp. lactis Bb-12 and Lacticaseibacillus rhamnosus LGG)
- Where
- China
- Volunteers
- 116 people
- Sponsor
- Fudan University
Anemia, Iron-deficiency
The Effect of Anemia in Infancy on the Microbiome and Systemic Metabolism
Serum and fecal samples were collected from infants at either 6-7 m of age or 12-13 m of age. Serum and feces were analyzed locally for hemoglobin status or evidence of parasites, and standard of care was provided.
- Conditions
- Anemia, Iron-deficiency, Iron Deficiency Anemia
- Trial name
- NCT03377777
- Testing
- No intervention
- Volunteers
- 203 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
Anemia, Iron Deficiency
Iron and Prebiotics Fortification in Kenyan Infants
Iron deficiency and anemia are health issues affecting mainly infants and women in developing countries. Iron deficiency in infancy can have long-lasting impact on cognitive and motor development of the child.
- Conditions
- Anemia, Iron Deficiency, Diarrhea, Malaria
- Trial name
- Iro'n'Pre (NCT02118402)
- Testing
- Fortified maize porridge
- Where
- Kenya
- Volunteers
- 155 people, healthy volunteers welcome
- Sponsor
- Swiss Federal Institute of Technology
Gut Microbiota, Skin Microbiota
Lactobacillus Rhamnosus GG: Interaction With Human Microbiota and Immunity
Hypothesis: Probiotics have been used as novel adjunct therapeutic approach in atopic dermatitis. In addition to balancing the gut microecology and promoting host immune defences, specific probiotics might further aid in…
- Conditions
- Gut Microbiota, Skin Microbiota, Humoral Immune Responses, Severity of Atopic Dermatitis
- Trial name
- NCT01148667
- Testing
- Casein hydrolysate added with LGG, Infants drink casein hydrolysate without LGG
- Where
- Finland
- Volunteers
- 40 people
- Sponsor
- Turku University Hospital
PE (Pre-eclampsia) High-risk Population With Gut Microbiota Dysbiosis During Their Pregnancy
Probiotic Supplementation During Pregnancy in Preeclampsia High-risk Groups
In this randomized controlled study, preventive intervention of aspirin combined with probiotics or aspirin combined with placebo would given to PE (pre-eclampsia) high-risk population with gut microbiota dysbiosis during their…
- Trial name
- NCT05554185
- Testing
- aspirin 100mg and probiotics 1 bag
- Volunteers
- 338 people
- Sponsor
- Nanfang Hospital, Southern Medical University
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
Healthy Infants
Characterization of the Gastrointestinal Microbiota in Newborn Infants
The BABIES study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with a 4-week intervention period from birth to 28 days of life followed by a 2-week follow-up period (Figure 1).
- Trial name
- BABIES I (NCT06789484)
- Testing
- Probiotic
- Where
- Denmark
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Hvidovre University Hospital
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
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
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
Microbiome, Neurodevelopment Outcome
The Premature Gut Microbiome and the Influence on Neonatal Immunity, Brain Development and White Matter Injury
Recent advances in neonatal intensive care have dramatically increased the survival rate of extremely premature infants but the number of survivors with severe morbidity and lifelong neurodevelopmental impairment remains high.
- Conditions
- Microbiome, Neurodevelopment Outcome, Immunology
- Trial name
- PreMiBraIn (NCT03213275)
- Testing
- Microbiome Sequencing, Neurophysiologic Assessment, Immunological test
- Where
- Austria
- Volunteers
- 60 people
- Sponsor
- Medical University of Vienna
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
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
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 Colic, Atopic Dermatitis
Use of Bifidobacterium Bifidum in Formula-Fed Infants With Colic, With or Without Atopic Dermatitis
The goal of this clinical trial is to evaluate whether daily probiotic supplementation with Bifidobacterium bifidum (Bifipral® drops) can reduce crying time in formula-fed infants aged 5 months or younger diagnosed with infant…
- Trial name
- NCT07754968
- Testing
- Bifidobacterium bifidum BFP19® and BFP29® (Bifipral®)
- Where
- Italy
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- University of Roma La Sapienza
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
Microbiota, Eczema
Intestinal Microbiota Composition After Antibiotic Treatment in Early Life
In this prospective observational cohort study the potential clinical consequences of antibiotic use in early life and perturbations in the gastrointestinal microbiota composition due to that antibiotic use are studied.
- Conditions
- Microbiota, Eczema, Atopy
- Trial name
- INCA (NCT02536560)
- Where
- 4 sites in Netherlands
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Agentschap NL