Clinical trials: Infant Gut Microbiome
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
Infant, Premature, Infants, Extremely Premature
The Alberta BLOOM Preterm Neonate Study
This is a prospective, observational clinical cohort study involving 100 mothers and their very preterm infants born at less than 32 weeks gestation.
- Conditions
- Infant, Premature, Infants, Extremely Premature, Microbiota, Gastrointestinal Microbiome
- Trial name
- BLOOM-PTN (NCT03840980)
- Where
- Canada
- Volunteers
- 55 people
- Sponsor
- University of Calgary
Necrotizing Enterocolitis of Newborn
The Intestinal Dysbacteriosis in the Pathogenesis of Necrotizing Enterocolitis
Study Description The goal of this observational study is to detect intestinal flora and the metabolic products in premature infants diagnosed as necrotizing enterocolitis. The main questions it aims to answer are: 1.
- Trial name
- NCT05619055
- Testing
- Routine treatment
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Zuohui Zhao
Formula Milk, Infants
Infant Formula Study With Pre- And Postbiotics
This prospective, single-arm study evaluates the gastrointestinal tolerance, safety, and growth, quality of life and gut microbiome development of healthy term infants fed a commercially available palm oil free infant formula…
- Trial name
- NCT07734532
- Testing
- Infant Formula
- Where
- Ireland
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Nutricia UK Ltd
Pregnancy, Gestational Weight Gain
Maternal Gestational Weight Gain and Microbiota of Maternal and Infant
A prospective, multicenter, observational cohort study including about 550 mother-infant pairs in Beijing will be conducted to evaluate the association between mothers' gestational weight gain and the gut microbiota of them and…
- Conditions
- Pregnancy, Gestational Weight Gain, Microbiota
- Trial name
- NCT03916354
- Where
- China
- Volunteers
- 550 people, healthy volunteers welcome
- Sponsor
- Peking Union Medical College Hospital
Obesity, Growth
Essential Fatty Acids During Complementary Feeding
The objective of this intervention study is to examine the effect of n-3 LCPUFA on growth and body composition, intestinal health and microbiotic composition, immune function and risk markers for later diseases in 9-18 months old…
- Conditions
- Obesity, Growth, Metabolic Syndrome, Cardiovascular Disease
- Trial name
- EFiON (NCT00631046)
- Testing
- Fish Oil, Sunflower Oil
- Where
- Denmark
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- University of Copenhagen
Beneficial Bacteria in Gut
Color Synbiotics Study
This study is initiated to investigate the effect of infant formula with added specific synbiotics mixture on proportion of beneficial bacteria.
- Trial name
- NCT01813175
- Testing
- Regular non-hydrolysed cow's milk I, Regular non-hydrolysed cow's milk II, Regular non-hydrolysed cow's milk - control
- Where
- 3 sites in Thailand
- Volunteers
- 290 people, healthy volunteers welcome
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
Weight Gain, Pregnancy, Microbial Colonization
Microbiome and Malnutrition in Pregnancy (MMiP)
Nutritional status during pregnancy plays an important role in maternal health and birth outcomes. While few factors impacting nutritional status during pregnancy have been identified, studies of undernutrition in children have…
- Conditions
- Weight Gain, Pregnancy, Microbial Colonization, Pregnancy Related, Pregnancy Loss
- Trial name
- MMiP (NCT05108675)
- Where
- Pakistan
- Volunteers
- 400 people
- Sponsor
- Aga Khan University
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
Health Behavior
Short and Long Term Effect of Early Infant Feeding and Nutritional Status on the Children's Health
This study evaluates the early infant feeding in the infant intestinal microecology and the long term health. 300 healthy term newborns were involved into the study on its first stage.
- Trial name
- NCT02658500
- Testing
- Infant Formula, breast milk
- Where
- 4 sites in China
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Beijing Sanyuan Foods Co Ltd
Infant Sleep Problems, Circadian Rhythm
Chrononutrition in Preterm Infants: a Randomised Controlled Trial of Time-matched Breast Milk Feeding and Its Effects on Sleep and Circadian Development
This study investigates whether the timing of feeding expressed breast milk influences infant sleep and circadian (day-night) development in preterm infants.
- Conditions
- Infant Sleep Problems, Circadian Rhythm, Neurodevelopment
- Trial name
- NCT07533578
- Testing
- Chronobiologically Timed Feeding of Expressed Breast Milk, Usual Feeding Practice (Untimed Expressed Breast Milk)
- Where
- Switzerland
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Luzerner Kantonsspital
Maternity Care, Nutrition Education
The Effects of Structured Lactation Nutrition Education and Dali ni Horbo Supplementation on Maternal Nutritional Intake, Breastfeeding Practices, Infant Growth, and Gut Microbiota: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effects of structured lactation nutrition education combined with Dali ni Horbo supplementation on maternal dietary intake, breastfeeding practices, infant growth, and infant…
- Trial name
- NCT07718087
- Testing
- Dali ni Horbo Supplementation, Standard Maternal Care
- Where
- Indonesia
- Volunteers
- 50 people
- Sponsor
- DINA KEUMALA SARI
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
Colic, Inflammation
Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic
This study will compare 2 currently marketed formulas in healthy full term babies: Nutramigen A+ (a hypoallergenic formula) and Nutramigen-Enflora (hypoallergenic formula with Lactobacillus GG (LGG)) during 3 months of formula…
- Trial name
- LGG (NCT01279265)
- Testing
- Nutramigen with Enflora, Nutramigen A+
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston
C-Section
Influence of Probiotics on Early Gut Microbial Colonization
The goal of this clinical trial is to learn whether daily probiotic drops plus vitamin D3 can improve early gut microbiome colonization in healthy infants born by C-section. It will also assess safety and tolerability.
- Trial name
- STORKIE (NCT07608341)
- Testing
- Probiotic drops
- Where
- 2 sites in Finland
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- BioGaia AB
Obesity, Childhood, Antibiotic Side Effect
Microbiome, Antibiotics, and Growth Infant Cohort
This cross-disciplinary study will assemble and longitudinally follow a large, diverse birth cohort to determine the relationships between early life antibiotic exposure, microbiome development, growth, antibodies, and…
- Trial name
- MAGIC (NCT03001167)
- Where
- United States
- Volunteers
- 509 people
- Sponsor
- Children's Hospital of Philadelphia
Necrotizing Enterocolitis, Death
The Efficacy and Mechanisms of Oral Probiotics in Preventing Necrotizing Enterocolitis
The purpose of this study is to investigate the efficacy and its mechanisms of oral mixture probiotics in preventing necrotizing enterocolitis among the preterm very low birth weight infants.
- Trial name
- NCT02552706
- Testing
- probiotics, glucose solution
- Where
- 4 sites in China
- Volunteers
- 270 people
- Sponsor
- Shenzhen Bao'an Maternal and Child Health Hospital
Infant, Premature
Influence of Intestinal Microbiota Implantation in Preterm Infants on Microbiota and Immune Orientation at 3 Years
The main objective of this research is to study the links between changes in the intestinal microbiota (in terms of diversity) during the first 6 weeks of life for preterm infants and the presence / absence of a TH1 immune status…
- Trial name
- PrimiBiota (NCT02738411)
- Where
- 3 sites in France
- Volunteers
- 130 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Less Than 3 Months Old, Healthy Infants
An Intervention Study in Healthy Infants Aged 0-6 Months With Probiotics Lacticaseibacillus Rhamnosus LRa05 (LRa05) and Bifidobacterium Animalis Subsp. Lactis BLa80 (BLa80) vs. Placebo, for Promoting Gut Microbiome Development.
The probiotics Bifidobacterium animalis subsp. lactis BLa80 and Lacticaseibacillus rhamnosus LRa05 have potential to enhance infant health and development based on previous research conducted on human infants.
- Trial name
- SMILE (NCT07505329)
- Testing
- Probiotic
- Where
- Ireland
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- University College Cork
Infant Nutrition
A New Adaptive Feeding Plan for Newborns
The purpose of this clinical trial is to identify the infant formula(s) for which the investigators get the closest gut maturation index compared to the one they get with breastfed babies.
- Trial name
- NCT00984230
- Testing
- BSF, BSF + Lactoferrin + Probiotics, BSF + Lactoferrin + Probiotics + OS
- Where
- 6 sites in Austria, France and 1 more
- Volunteers
- 186 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)