Clinical trials: Gastrointestinal Microbiome
- Condition Gastrointestinal Microbiome
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
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
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
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
Children With Allergic Rhinitis
Effectiveness of Probiotics in Relieving Allergic Rhinitis in Children
To evaluate the clinical efficacy of probiotic gummies in the trial of allergic rhinitis in children compared to placebo, as well as the modulating effect on gut microbiota, serum metabolic profile, and occurrence of adverse…
- Trial name
- NCT06676111
- Testing
- Probiotic
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Wecare Probiotics 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
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)
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.
Acne Vulgaris, Acneiform Eruptions
The Effects of Oral Probiotics and Herbal Supplementation on the Gut Microbiome and Sebum Excretion Rate in Non-Cystic Acne
The purpose of this study is to evaluates how probiotics and dietary supplementation with an herbal powder can shift the gut microbiome in those with non-cystic acne vulgaris.
- Conditions
- Acne Vulgaris, Acneiform Eruptions, Skin Diseases, Sebaceous Gland Diseases
- Trial name
- NCT05919810
- Testing
- Probiotic, Oral herbal powder supplement
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Integrative Skin Science and Research
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
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.
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
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
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)
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
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)
Acne Vulgaris
Comparing Sarecycline and Doxycycline Effects on the Skin and Gut Bacteria in Acne.
This study is being done to help better understand how the gut and skin bacteria of the body change when people with acne are treated with Sarecycline or Doxycycline.
- Trial name
- NCT07544251
- Testing
- Sarecycline, Doxycycline
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Integrative Skin Science and Research
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
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.
Dysbiosis, Prophylaxis
Lactobacillus Reuteri DSM 17938 in Gut Microbiota Development in Infant Born by Caesarean Section
The aim of this study is to assess influence of probiotic Lactobacillus reuteri DSM 17938 on formation of gut microbiota in infant born by Caesarean section.
- Trial name
- NCT03675048
- Testing
- BioGaia Protectis drops
- Where
- Russia
- Volunteers
- 97 people
- Sponsor
- BioGaia AB
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)