Clinical trials: Infant Gut Microbiome
Follow-on Formula, Infant
Effect of follow-on Formula on the Gut Microbiota of Healthy Infants.
This study investigates the effects of follow-on formula in infants aged 6-9 months over a 12-week period. After parents give consent, their baby's feeding habits, stool characteristics, and any illnesses or medication use will…
- Conditions
- Follow-on Formula, Infant, Faeces, Gut Microbiota
- Trial name
- FUNTASTIC (NCT07207109)
- Testing
- Test: Follow-on formula with synbiotics, Control: Regular follow-on formula
- Where
- 2 sites in Indonesia
- Volunteers
- 268 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Gut Microbiota
Characterization of the Gastrointestinal Microbiota in Term Newborn Infants After 4 Weeks Supplementation of Probiotics
A mono center, open label, pilot study in term newborn infants. The study will investigate the effect of supplementation with probiotics on the presence of total Bifidobacterium in the infant feces.
- Trial name
- NCT04994834
- Testing
- Probiotics
- Where
- Denmark
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Chr Hansen
Cystic Fibrosis, Hirschprung's Disease
Evaluating the Alimentary and Respiratory Tracts in Health and Disease (EARTH) Research Program.
The investigators have established the "Evaluating the Alimentary and Respiratory Tracts in Health and disease" (EARTH) research program.
- Conditions
- Cystic Fibrosis, Hirschprung's Disease, Obstructive Sleep Apnea, Healthy
- Trial name
- EARTH (NCT04071314)
- Where
- Australia
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- The University of New South Wales
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
Infant Growth, Infant Body Fat
Effect of Protein From Complementary Foods on Infant Growth, Body Composition and Gut Health
Current research shows that dairy protein accelerates infant weight gain, which is a risk factor for later on obesity and metabolic syndrome. However, dietary protein from other sources haven't been studied yet.
- Conditions
- Infant Growth, Infant Body Fat, Infant Gut Microbiome
- Trial name
- NCT02142647
- Testing
- a high-protein complementary diet with meat, a high-protein complementary diet with dairy
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Gut Microbiome
Rescuing the Microbiome Effectively With Different Doses of B. Infantis in Infants
The REMEDI Study is a single-center, prospective, double-blind, randomized, placebo-controlled trial of multiple doses of B. infantis EVC001 supplementation in healthy term breastfed infants.
- Trial name
- REMEDI (NCT03476447)
- Testing
- B. infantis EVC001, Lactose
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Evolve BioSystems, Inc.
Healthy Children
Study to Evaluate the Effects of a Formula on the Gut Health of Healthy Chinese Infants and Young Children
The infant gut microbiota, a major driver of the maturation of the immune system, is formed through the successive establishment and development during infancy and early childhood.
- Trial name
- NCT04864665
- Testing
- a formula with prebiotics and milk fat
- Where
- 6 sites in China
- Volunteers
- 455 people, healthy volunteers welcome
- Sponsor
- Danone Nutricia
Cow's Milk Allergy
Oral Tolerance in Cow's Milk Allergy in the Infant
This study aims to determine if there is a link between cow's milk allergy in infants and regulatory T cells dysfunction that should be transient in infant acquiring oral tolerance after 12 month avoiding food and persistent in…
- Trial name
- NCT00298376
- Where
- France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
Malnutrition Pregnancy, Malnutrition in Children
Early Life Malnutrition, Environmental Enteric Dysfunction and Microbiome Trajectories
Malnutrition in women of reproductive age remains a public health concern in Sub-Saharan Africa (SSA). Malnutrition during pregnancy affects foetal growth with a tendency of the exposed infants to also develop it.
- Conditions
- Malnutrition Pregnancy, Malnutrition in Children, Malnutrition (Calorie), Environmental Enteric Dysfunction
- Trial name
- UZBCS-2 (NCT07195006)
- Testing
- Malnutrition in pregnancy as exposure, Poor WASH living conditions as exposure
- Where
- Zimbabwe
- Volunteers
- 368 people, healthy volunteers welcome
- Sponsor
- University of Zimbabwe
Gut Microbiome, Linear Growth
Effects of Complementary Feeding on Infant Growth and Gut Health
This study plans to learn more about how consuming different foods during the time of early complementary feeding (~5 to 12 months) affects growth and the development of bacteria living inside your baby's gut through school-age.
- Trial name
- MINT (NCT05012930)
- Testing
- Baby Foods - Meat, Baby Foods - Dairy, Baby Foods - Plant
- Where
- United States
- Volunteers
- 267 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Healthy Mothers, Healthy Infants
Maternal High Fibre Fermented Diet Effect on Breastfed Infant Gut Microbiome
Breastfeeding is recommended for babies from birth to six months old because breast milk provides all the nutrients babies need for growth and development.
- Trial name
- MumBabyGut (NCT06977113)
- Testing
- High Fibre Fermented Food Diet, Control Habitual Diet
- Where
- United Kingdom
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- University of Glasgow
Retinopathy of Prematurity, Microbiome
The Analysis of Association of Retinopathy of Prematurity, Gut Microbiome Profile, and Systemic Inflammation
Study Aims 1. Understanding the gut microbiome profile in very low birth weight infants with or without ROP. The onset and aggravation of ROP and their relationship with gut microbiome will be examined. 2.
- Trial name
- NCT05144282
- Testing
- intravitreal injection of anti VEGF, laser photocoagulation
- Where
- Taiwan
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Chang Gung Memorial Hospital
Infection, Enterocolitis, Necrotizing
Oropharyngeal Administration of Mother's Colostrum for Premature Infants (NS-72393-360)
Extremely premature (BW<1250g) infants are at high risk for morbidity and mortality. Own mother's colostrum (OMC) and milk (OMM) protect against neonatal morbidity and are rich in immune factors which may provide…
- Conditions
- Infection, Enterocolitis, Necrotizing, Ventilator-associated Pneumonia
- Trial name
- NCT02116699
- Testing
- oropharyngeal mother's milk, oropharyngeal sterile water
- Where
- 5 sites in United States
- Volunteers
- 260 people
- Sponsor
- Endeavor Health
Pregnancy Related, Pregnancy Loss
Microbiome and Malnutrition in Pregnancy
This study is being conducted to investigate how a mother's nutritional status and her gut microbiome during pregnancy contribute to the birth outcomes and health of her baby.
- Conditions
- Pregnancy Related, Pregnancy Loss, Pregnancy Complications, Pregnancy; Parasitic Disease
- Trial name
- MMIP (NCT04992104)
- Where
- 2 sites in Canada
- Volunteers
- 800 people
- Sponsor
- The Hospital for Sick Children
Mixed Flora; Infection
Preterm Infant Gut (PINGU) - a Norwegian Multi Centre Study
Necrotizing enterocolitis (NEC) is a leading cause of morbidity and mortality among infants in the neonatal intensive care unit (NICU).
- Trial name
- PINGU (NCT02197468)
- Where
- 7 sites in Norway
- Volunteers
- 60 people
- Sponsor
- University Hospital of North Norway
Healthy Infants
Colonisation Resistance Study
This study is initiated to investigate the effect of infant formulas with added specific prebiotic oligosaccharides on the reduction of specific potential pathogens and/or toxins.
- Trial name
- ColoR (NCT01507935)
- Testing
- Regular non-hydrolysed cow's milk
- Where
- 2 sites in Thailand
- Volunteers
- healthy volunteers welcome
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
Anemia, Neonatal, Necrotizing Enterocolitis
Alteration of Stool Microbiota in Preterm Infants With Anemia
This study evaluates the relationship between anemia and stool microbiota in premature infants. It also evaluates the relationship between blood transfusion and stool microbiota.
- Conditions
- Anemia, Neonatal, Necrotizing Enterocolitis, Dysbiosis
- Trial name
- NCT03554278
- Where
- United States
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Rotavirus Infections, Reaction - Vaccine Nos
Does the Fecal Microbiome Influence Rotarix Immunogenicity
This is a proposal for a nested case-control study within an ongoing rotavirus vaccine immunogenicity clinical trial Karachi, Pakistan.
- Conditions
- Rotavirus Infections, Reaction - Vaccine Nos, Intestinal Bacteria Flora Disturbance
- Trial name
- NCT02220439
- Volunteers
- 76 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Microbial Colonization
The Influence of Infant Feeding Type on Preterm Infant's Intestinal Microbiome
This study aims to examine the factors associated with preterm infant's intestinal microbiota depending on feeding type (breast milk or preterm formula)
- Trial name
- NCT04972214
- Where
- South Korea
- Volunteers
- 50 people
- Sponsor
- CHA University
Gut Microbiome
User Testing of the Evivo Screening Test
The study is an evaluation of the Evivo Screening Test's ability to differentiate between high and low levels of Bifidobacterium in infant stool specimens.
- Trial name
- NCT03601936
- Testing
- Evivo Infant Gut Bifidobacterium Screening Test
- Where
- 5 sites in United States
- Volunteers
- 231 people, healthy volunteers welcome
- Sponsor
- Evolve BioSystems, Inc.