Clinical trials: Infant Gut Microbiome, open to volunteers
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
Gut Microbiome, Neurocognitive Correlates of Eating Habits
Early Avocado Exposure on Development and the Gut Microbiome in American Hispanic Infants
The goal of this clinical trial is to learn if daily avocado intake can improve growth and brain and gut health in infants. The main questions it aims to answer are: Does daily eating of avocados change which microbes live in the…
- Conditions
- Gut Microbiome, Neurocognitive Correlates of Eating Habits, Infant Growth
- Trial name
- Guac & Grow (NCT06876935)
- Testing
- Daily avocado
- Where
- United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Arizona State University
Microbiota, Gut Microbiome
Flourish: Exploring the Early Infant Gut Microbiome
The goal of this clinical trial is to learn whether microbiome analysis, education, and personalized recommendations can improve gut health and reduce early markers of immune-related conditions in infants aged 0-3 months…
- Conditions
- Microbiota, Gut Microbiome, Eczema, Microbiome
- Trial name
- NCT07333482
- Testing
- Tailored Recommendations, Consult Call, Educational Email Series
- Where
- United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Seeding Inc
Gut Microbiome
Developing Interventions for Protecting HIV-Exposed Uninfected Infants Against Severe Infections
Research has shown that babies who are exposed to HIV, but are uninfected (negative HIV status), have a bigger risk of developing severe infections.
- Trial name
- NCT07052409
- Testing
- Inkomazi
- Where
- South Africa
- Volunteers
- 72 people
- Sponsor
- University of Colorado, Denver
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
Respiratory Syncytial Virus Infection, Bronchiolitis
Gut Microbiome and Immune Response in Severe RSV Infection in Vietnamese Infants
Respiratory syncytial virus (RSV) is a leading cause of severe lower respiratory tract infection in young children, and a substantial proportion of severe cases occur in previously healthy infants.
- Conditions
- Respiratory Syncytial Virus Infection, Bronchiolitis, Viral Lower Respiratory Tract Infection (LRTI)
- Trial name
- GUT-LUNG RSV (NCT07417657)
- Where
- Vietnam
- Volunteers
- 250 people
- Sponsor
- Phuc Huu Phan
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
Healthy Infants
Study on the Effects of Probiotic on Infant Gut Microbiota and Immune Regulation
This is a probiotic intervention study in healthy infants aged 0 - 6 months. The primary objective is to evaluate the effects of Lacticaseibacillus paracasei LPB27 (also known as Lacticaseibacillus paracasei 207-27)…
- Trial name
- NCT07896083
- Testing
- Probiotic, Maltodextrin
- Where
- China
- Volunteers
- 370 people, healthy volunteers welcome
- Sponsor
- BYHEALTH Co., LTD
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
Infantile Colic
Effect of Probiotics on Infantile Colic Symptoms
The aim of this clinical trial is to assess the impact of B. lactis B94 on participants with infantile colic. It is hypothesized that participants given the probiotic formula will have a significant reduction in their crying…
- Trial name
- EPIC (NCT06385054)
- Testing
- Probiotic
- Where
- 10 sites in France
- Volunteers
- 70 people
- Sponsor
- Lallemand Health Solutions
Infant, Newborn, Immunity
The Bloom Infant Probiotic (BIP) Study
The goal of this clinical trial is to investigate whether administering a probiotic (Infloran®) to infants who received antibiotics in the first 28 days of life can restore or enhance their immune response to routine vaccines.
- Conditions
- Infant, Newborn, Immunity, Immunisation, Antibiotic Treatment
- Trial name
- BIP (NCT07189390)
- Testing
- Probiotic
- Where
- 2 sites in Australia
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- South Australian Health and Medical Research Institute
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
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"
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
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
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)
Healthy, Healthy Nutrition
The BEGIN Study Bifidobacterium Infantis to Newborns: Effects of Modulating the Gut Microbial Composition on Growth, Immune Function and Inflammatory Conditions - a Randomized Placebo-controlled Double-blinded Intervention Trial
The goal of The BEGIN Study, a randomized controlled double-blinded intervention trial, is to learn if probiotics, with Bifidobacterium longum subspecies infantis Bifin02 (B.
- Trial name
- BEGIN (NCT06452199)
- Testing
- B. infantis
- Where
- 2 sites in Denmark
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
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
Functional Gastrointestinal Disorders (FGIDs), Weight Loss
Effects of Multi-strain Bacillus Spore Probiotics on Growth, Digestive Function, and Gut Microbiota in Cesarean-Delivered Neonates
Infants born by cesarean section commonly show early weight loss and slower recovery of birth weight, together with characteristic patterns of gut microbiota dysbiosis marked by reduced Bifidobacterium and Bacteroides and…
- Trial name
- NCT07320287
- Testing
- RO water, LiveSpo PREG-MOM, LiveSpo CONSY
- Where
- Vietnam
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Anabio R&D
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