Clinical trials: Infant Gut Microbiome
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
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)
Focus on Healthy Infant Growth.
Infant Formula Supplemented With Probiotic Microorganisms and/or Prebiotic.
Evaluation the nutritional suitability of a based milk infant formula supplemented with friendly bacteria (probiotic microorganisms) and or nutritional fibers (prebiotic) to healthy, full term infants compare with an otherwise…
- Trial name
- NCT00836771
- Testing
- Infant Formula
- Where
- Israel
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- Materna Laboratories
Low Birth Weight Infants
The Influence by Dietary Human Milk Oligosaccharide in Low Birth Weight Infants
This study aims to investigate the concentration of various growth factors and cytokines in blood, and to examine the gut microbiota of low birth weight infants fed with formulas with or without Human Milk Oligosaccharide (HMO)…
- Trial name
- NCT05203900
- Testing
- Infant formula with Human Milk Oligosaccharide, Infant formula without Human Milk Oligosaccharide
- Where
- Thailand
- Volunteers
- 60 people
- Sponsor
- Meiji Co., Ltd.
Atopic Dermatitis
Probiotic on Atopic Dermatitis in Infant
The clinical trial will be carried out in China Medical University Hospital. The overall plan is a double-blind trial. All recruited 3 months-3 years old atopic dermatitis (AD) patients are divided into two groups, 50 in each…
- Trial name
- NCT05286047
- Testing
- Bifidobacterium longum CCFM1029
- Where
- Taiwan
- Volunteers
- 100 people
- Sponsor
- Glac Biotech Co., Ltd
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
Cows Milk Allergy
Synbiotics Cohort Study
Observational study exploring the clinical outcomes of infants with cow's milk allergy who are prescribed a hypoallergenic formula containing synbiotics.
- Trial name
- NCT05046418
- Testing
- Hypoallergenic formula containing synbiotics
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Nutricia UK Ltd
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
Diarrhea, Atopic Dermatitis
Cesarean Section Study
Effect, tolerance and safety of a supplementation with a probiotic on the risk of gastrointestinal infections, on growth, and on gut microbiota in healthy newborn term infants born by Cesarean section.
- Trial name
- NCT01992497
- Testing
- Probiotic
- Where
- Germany
- Volunteers
- 721 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
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
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.
Digestion, Gut Microbiota
Feeding Tolerance and Gut Maturation of Infants Consuming a Formula Rich in Glycoprotein
This is a non-randomized, single-arm, open-label, prospective interventional study using a commercially available starter infant formula in healthy term formula-fed infants with a parallel group of healthy term breast-fed infants…
- Trial name
- NCT04880083
- Testing
- Commercially Available Starter Infant Formula
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
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
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.
Gastrointestinal Microbiome
Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas
This clinical trial will compare stool and oral microbiome composition between infants fed breast milk or one of two infant formulas for a 60 day feeding period.
- Trial name
- NCT04059666
- Testing
- Investigational, Control
- Where
- 5 sites in United States
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Mead Johnson Nutrition
Gut Microbiota
Effect of an Infant Formula With Synbiotics in Infants Born Via Caesarean Section
A multi-centre, randomized, parallel-group, double-blind, controlled, exploratory clinical trial is conducted to assess the positive effect of feeding a formula containing synbiotics (pre- and probiotics) on the composition of…
- Trial name
- GOLF-CS (NCT04991792)
- Testing
- Intervention Group 1: Infant Formula with synbiotics, Intervention Group 2: Infant Formula with prebiotics, Control Group 1 and 2: Infant Formula without synbiotics
- Where
- Bulgaria
- Volunteers
- 486 people, healthy volunteers welcome
- Sponsor
- HiPP GmbH & Co. Vertrieb KG
Cow Milk Allergy
A Growth and Hypoallergenicity Study of a New Formula for Infants With Cow Milk Allergy
This study involves the use of 2 different Neocate formulas: a control formula called Neocate Infant and a test Neocate formula.
- Trial name
- CMA (NCT00664768)
- Testing
- Neocate Infant, new Neocate
- Where
- 22 sites in United States
- Volunteers
- 126 people
- Sponsor
- Nutricia North America
Immunity
A Clinical Study to Investigate the Effect of a Partially Hydrolysed Infant Formula With Added Synbiotics on Gut Microbiota Composition and Clinical Effectiveness in Infants at High Risk of Developing Allergy
With the rising prevalence of allergic diseases and the subsequent risk of developing other immune-related disorders, primary prevention of allergy has become a major priority.
- Trial name
- TEMPO (NCT03067714)
- Testing
- Infant formula with added synbiotics, Standard infant formula
- Where
- 59 sites in Belgium, Czechia and 11 more
- Volunteers
- 855 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
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
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.