Clinical trials: Human Microbiome
Gestational Diabetes Mellitus (GDM), Microbiome, Human
A Probiotic Based Intervention in Pregnancies Complicated by GDM
This study is a single center randomized control trial of a probiotic based intervention in pregnancies complicated by gestational diabetes.
- Trial name
- ProbioGDM (NCT06794723)
- Testing
- 5-strain probiotic plus prebiotic natural health product
- Where
- Canada
- Volunteers
- 173 people
- Sponsor
- Queen's University
Hormonal Contraception
Contraceptive Hormones, Immunity, and Microbiome Evaluation
The study is a prospective cohort study to explore the mechanisms underlying the HIV risk associated with pharmacologic doses of exogenous sex hormones via hormonal contraceptives specially progestin-containing hormonal…
- Trial name
- CHIME (NCT03660046)
- Testing
- Depot medroxyprogesterone acetate (DMPA), Etonogestrel implant (Eng-Implant), Levonorgestrel IUD (Lng-IUD)
- Where
- 3 sites in United States
- Volunteers
- 155 people, healthy volunteers welcome
- Sponsor
- Emory University
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
Irritable Bowel Syndrome
Probiotics in the Treatment of Irritable Bowel Syndrome
The aim of the present study is to assess the efficacy of two different probiotic products, lacto-fermented sauerkraut and the supplement Mutaflor, in the treatment of irritable bowel syndrome.
- Trial name
- NCT02953171
- Testing
- Raw, lacto-fermented sauerkraut, Mutaflor, Pasteurized sauerkraut
- Where
- Norway
- Volunteers
- 140 people
- Sponsor
- University of Copenhagen
Pregnancy, Obesity
PregnanT Moms Measure - Do-It-Yourself Health Monitoring and Simulation of Health in Pregnant Women
The aim of this pilot study is to determine the feasibility of Do-It-Yourself studies in pregnant women to detect changes in health parameters by assessing compliance and user experiences of participants.
- Trial name
- oPTiMuM (NCT02537145)
- Where
- Netherlands
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- W.J. Pasman
Infantile Colic, Breast Feeding
The Role of Human Milk Oligosaccharides and Microbiomes on Infantile Colic and Atopic Dermatitis in Term Infants
Background: Human milk oligosaccharides (HMO) and microbiota are both key factors for infants to shape the gut flora and develop the immune system.
- Conditions
- Infantile Colic, Breast Feeding, Atopic Dermatitis, Infant Formula
- Trial name
- NCT05992493
- Where
- Taiwan
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- National Cheng-Kung University Hospital
Very Low Birth Weight Baby, Early Nutrition and the Preterm Infant
Optimizing Nutrition and Milk (Opti-NuM) Project
Early nutrition critically influences growth, neurodevelopment and morbidity among infants born of very low birth weight (VLBW), but current one-size-fits-all feeding regimes do not optimally support these vulnerable infants.
- Conditions
- Very Low Birth Weight Baby, Early Nutrition and the Preterm Infant, Nutritional Requirements, Human Milk Fortification
- Trial name
- Opti-NuM (NCT06870981)
- Testing
- Opti-NuM is an observational secondary use of data/samples study, the investigators will analyze information and specimens from the MaxiMoM platform RCTs. No interventions form part of this study.
- Where
- 6 sites in United States, Canada
- Volunteers
- 1,100 people
- Sponsor
- The Hospital for Sick Children
Atopic Dermatitis
Vitamin D Treatment Effect for Atopic Dermatitis in Children
A double-blind study to evaluate the role of human microbiome and vitamin D in the development of atopic dermatitis.
- Trial name
- NCT05523986
- Testing
- Vitamin D
- Where
- Taiwan
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- China Medical University Hospital
Skin Microbiome
Skin Microbiome of Chinese Population Cohort Study
This observational study aims to investigate the relationship between public health and the skin microbiome in the province of Zhejiang.
- Trial name
- NCT05804851
- Where
- China
- Volunteers
- 237 people, healthy volunteers welcome
- Sponsor
- Westlake University
Infant, Very Low Birth Weight
Growth and Microbiome Development in Very Low Birth Weight Infants Fed Primarily Mother's Own Milk vs. Donor Human Milk
A study to compare growth, development of the intestinal bacterial environment, and other short term outcomes in groups of babies fed primarily their own mother's milk compared to those who receive primarily donor human milk.
- Trial name
- NCT02573779
- Testing
- Observational - no intervention
- Where
- 2 sites in United States
- Volunteers
- 125 people
- Sponsor
- Baylor College of Medicine
Microbial Colonization, Atopic Dermatitis
Nationwide Research on the Rewilding of Kindergarten Yards
Biodiversity is essential for nature and human well-being. Land use has reduced biodiversity in cities that is associated with altered commensal microbiota and a rising burden of immunological disorders among urban children.
- Conditions
- Microbial Colonization, Atopic Dermatitis, Asthma in Children, Allergy
- Trial name
- Vahvistu (NCT06390878)
- Testing
- Biodiversity, Playground equipment
- Where
- 2 sites in Finland
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- Natural Resources Institute Finland
Breast Milk Collection, Human Milk/Breastfeeding
Human Milk and Its Effect on Infant's Metabolism and Infant Gut Microbiome
This protocol explains the MAINHEALTH cohort. The study examine the influence of maternal health parameters on human breast milk composition and integrates milk phenotype with infant metabolism and infant gut microbial content…
- Conditions
- Breast Milk Collection, Human Milk/Breastfeeding, Human Milk Microbiome, Infant Gut Microbiome
- Trial name
- MAINHEALTH (NCT05111990)
- Where
- Denmark
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Healthy Newborn Infants
Resilience to Antibiotic-induced Obesogenic Microbiota: Discovering Mechanism of Microbiota Modulation
The aim is to study whether the microbiota of children who are exposed to antibiotics at birth could be modified by synbiotic supplement and thereby reduce the risk of obesity, chronic diseases and respiratory tract infections.
- Trial name
- ReCoverHealth (NCT06974994)
- Testing
- Synbiotic Supplement
- Where
- Finland
- Volunteers
- 125 people
- Sponsor
- Turku University Hospital
Host and Microbiome, Pregnancy Outcomes
Human Genes and Microbiota in Early Life
The long-term goal of the Human Genes and Microbiota in Early Life (HuGME) is to explore the short- and long-term effects of maternal microbiota during pregnancy and the microbiota colonization of their offspring early in life…
- Conditions
- Host and Microbiome, Pregnancy Outcomes, Pregnancy Complications, Neurodevelopmental Disorders
- Trial name
- HuGME (NCT06926166)
- Testing
- No intervention
- Where
- China
- Volunteers
- 20,000 people, healthy volunteers welcome
- Sponsor
- Guangzhou Women and Children's Medical Center
Early Life Adversity, Microbiome, Human
Between the Belly and the Brain: Distorted Gut-brain Crosstalk in Early-life Adversity
The goal of this observational study is to learn about the effects of early-life adversity (ELA) on the composition of children's microbiome and on their psychosocial functioning.
- Conditions
- Early Life Adversity, Microbiome, Human, Anxiety Symptoms, Depressive Symptoms
- Trial name
- BellyBrain (NCT06922773)
- Testing
- Completion of questionnaires; child psychiatric screening; faecal sample analysis
- Where
- Belgium
- Volunteers
- 50 people
- Sponsor
- Universitair Ziekenhuis Brussel
Infant Development, Body Composition, Beneficial
OTIS - Optimized Complementary Feeding Study
Dietary factors during infancy, e.g. high intakes of protein, fast carbohydrates and saturated fat increase the risk of adult obesity, type 2 diabetes and hypertension.
- Conditions
- Infant Development, Body Composition, Beneficial, Dietary Modification
- Trial name
- OTIS (NCT02634749)
- Testing
- Systematic introduction of taste portions, Protein reduced complementary foods, Nordic diet
- Where
- Sweden
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Umeå University
Inflammatory Bowel Disease, Ulcerative Colitis
Pediatric FEcal Microbiota Transplant for Ulcerative Colitis
The PediFETCh study is a pilot trial designed to assess the feasibility of fecal microbiota transplants for the therapy of pediatric ulcerative colitis (UC) and pediatric inflammatory bowel disease-unclassified (IBD-U).
- Trial name
- PediFETCh (NCT02487238)
- Testing
- Fecal Microbiota Enema, Normal Saline Enema
- Where
- 3 sites in Canada
- Volunteers
- 35 people
- Sponsor
- McMaster Children's Hospital
Human Microbiome, Pediatrics
Human Microbiome Research and Development for Overcoming Pediatric Diseases
Prediction and treatment of pediatric diseases and long-term outcomes through microbiome and multi-omics analysis by life cycle: We aim to demonstrate that a wide range of diseases are associated with gut microbiome dysbiosis and…
- Conditions
- Human Microbiome, Pediatrics, Disease, Growth & Development
- Trial name
- NCT06812091
- Where
- South Korea
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Hanyang University
Asthma, Asthma Attack
Genomics and Metagenomics of Asthma Severity
The Genomics and Metagenomics of Asthma Severity (GEMAS) study aims to assess the role of genomics, the microbiome, and the interaction between them in the development of asthma exacerbations in European patients with asthma.
- Trial name
- GEMAS (NCT04501926)
- Where
- 6 sites in Spain
- Volunteers
- 300 people
- Sponsor
- Maria Pino-Yanes
Microbial Colonization
Comparing Impacts of Donor Human Milk to Formula Supplementation on the Gut Microbiome of Full-term Infants
The goal of this pilot randomized controlled trial (RCT) is to examine donor human milk (DHM) as a clinical intervention targeted at achieving beneficial microbiome signatures in full-term infants who are exposed to intrapartum…
- Trial name
- PPDHM (NCT05815433)
- Testing
- Donor Human Milk - Nutritional Replacement
- Where
- Canada
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- University of Calgary