Clinical trials: Gut
Gut Microbiota Modulation
STUDY OF THE EFFECTS OF L. CASEI DG® (ENTEROLACTIS BABY) IN HEALTHY PRETERM AND FULL-TERM INFANTS.
The goal of this clinical trial was to learn whether giving Enterolactis Baby®, a probiotic food supplement containing Lactobacillus casei DG® (under the new taxonomical denomination: Lacticaseibacillus paracasei DG, CNCM…
- Trial name
- NCT07882537
- Testing
- Enterolactis Baby® drops
- Where
- Italy
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Alfasigma S.p.A.
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
Fecal Gut Microbiota
National Cohort Study on Infant Gut Microbiota and Nutrition
This study plans to collect 106,667 fecal samples from Chinese infants and children under 6 years old, with multi-dimensional stratification based on geographic location, mode of delivery, antibiotic exposure, and developmental…
- Trial name
- NCT07705685
- Testing
- Fecal sample collection and gut microbiome profiling
- Where
- China
- Volunteers
- 106,667 people
- Sponsor
- DiproBio (Shanghai) Co., Ltd.
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 Health, Gastrointestinal Diseases
Improved Gut Health Outcomes Associated With Probiotics Fortified With Hydrolyzed Whey Protein in Infant Formula
The goal of this interventional clinical trial is to test the effectiveness of improving gut health in terms of frequency of bowel movements in newly born infants fed with Feihe investigational formula product containing…
- Trial name
- NCT06159088
- Testing
- Feihe Investigational Formula, Control Formula, Breastfeeding
- Where
- 3 sites in China
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
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)
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
Autism Spectrum Disorder, Gastrointestinal Dysfunction
ASC - Autism Study
The ASC - Autism Pilot Study is a single center randomized open dose titrating phase I clinical intervention pilot trial with the aim of investigating safety and treatment effect of an allogeneic adipose tissue derived…
- Conditions
- Autism Spectrum Disorder, Gastrointestinal Dysfunction, Leaky Gut Syndrome, Mesenchymal Stromal Cells
- Trial name
- NCT05602116
- Testing
- Adipose tissue derived mesenchymal stromal/stem cells (Cell2Cure®)
- Where
- Denmark
- Volunteers
- 10 people
- Sponsor
- Cell to Cure ApS
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
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
Infant Gut Microbiome
The EFFECT Study: Probiotic and HMO Supplementation in Infants
Lacto-N-tetraose (LNT) is a human milk oligosaccharide (HMO) present in human colostrum and milk. HMOs are largely undigestable and have no direct nutritive benefit to the infant, but act as a prebiotic substrate for beneficial…
- Trial name
- EFFECT (NCT03994315)
- Testing
- B. infantis EVC001, Lacto-N-tetraose (LNT)
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Evolve BioSystems, Inc.
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.
Human Gut Microbiome Development
Phages Dynamics and Influences During Human Gut Microbiome Establishment
Microbial communities are key components of human environment. Consequently, human gut microbiome have been extensively studied providing a better understanding of the relations between bacterial populations and host physiology.
- Trial name
- METAKIDS (NCT03296631)
- Testing
- collection of diapers with fresh stools
- Where
- 2 sites in France
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
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.
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.
Gut Inflammation
A1 Versus A2® Milk on the Gastrointestinal Physiology, Symptoms and Cognitive Behaviour for the Preschool Children
This is a multiple-sites, double-blinded, randomized, controlled, parallel-designed, cross-over study among healthy preschoolers with 5 days consumption of A2 or A1 milk to compare the effects on gut inflammation…
- Trial name
- NCT03081845
- Testing
- Oral consumption of milk A1 in study phase 1, Oral consumption of milk A2 in study phase 1, Oral consumption of milk A1 in study phase 2
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- a2 Milk Company Ltd.