Clinical trials: Human Microbiome
Acute Ischemic Stroke
Dynamic Changes of the Human Microbiome Predict the Risk of Poor Prognosis in Patients With Acute Ischemic Stroke: a Multi-center Study
Recent studies have found a close relationship between acute ischemic stroke(AIS) and gut microbiota, but whether the dynamic changes in human microbiome after stroke can predict poor prognosis of stroke remains unclear.
- Trial name
- NCT04978701
- Where
- China
- Volunteers
- 2,000 people
- Sponsor
- Nanfang Hospital, Southern Medical University
Acne Vulgaris, Acne
Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris
Acne vulgaris, or acne, is one of the most prevalent diseases worldwide, with skin conditions being one of the top causes of years lived with disability and non-fatal disease burden.
- Trial name
- OREA (NCT05131373)
- Testing
- ORG101 - Experimental 1
- Where
- 6 sites in Germany
- Volunteers
- 38 people
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Microbial Colonization
Lactamica 9: Neisseria Lactamica Inoculation in Late Pregnancy
Bacteria living in the nose and throat are generally harmless, but in some circumstances cause infections of the lungs (pneumonia) and brain (meningitis), which are among the commonest causes of death worldwide in young children…
- Trial name
- NCT04784845
- Testing
- N. lactamica Y92-1009
- Where
- United Kingdom
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- University of Southampton
IBD (Inflammatory Bowel Disease)
Human and Microbial Determinants of the Onset of IBD Flares
This study will collect longitudinal biological samples and survey data to identify the triggers of IBD flares.
- Trial name
- NCT06967311
- Where
- Brazil
- Volunteers
- 100 people
- Sponsor
- Viome
Physical Abilities, FMT
Assessing the Potential Role of the Gut Microbiome in Modulating Physical Abilities in Humans
The intestinal microbiome is a microbial system that is influenced by host genetics and environmental exposures such as nutrition, stress and medications.
- Trial name
- NCT05024188
- Testing
- Antibiotics, Autologous Fecal Microbiota Transplantation, Cellules Pills
- Where
- Israel
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Assaf-Harofeh Medical Center
Healthy
SwissGut - The Healthy Swiss Microbiome
Objective: This study is designed to address the complex interplay between the gut microbiome, environmental factors, and inflammatory diseases, with a specific emphasis on serving as a healthy cohort for several related…
- Trial name
- SwissGut (NCT06191224)
- Where
- Switzerland
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Benjamin Misselwitz
Obesity
The Effects of Natural Sugars in Breast Milk on Healthy Infant Growth and Development
This study will investigate the effects of breastfeeding and breastmilk composition on infant gut microbiome development as well as obesity and cognitive outcomes.
- Trial name
- NCT04434027
- Where
- United States
- Volunteers
- 221 people, healthy volunteers welcome
- Sponsor
- University of Southern California
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
Insulin Sensitivity, Overweight or Obesity
Pulses Consumption and Its Role in Managing Systemic Inflammation, Insulin Sensitivity and Gut Microbiome in Human
Objective 1: Characterize indices of systemic inflammation and gut microbiota composition and function after chronic (12 weeks) intake of pulses compared to control diet in human OW/OB-IR participants.
- Conditions
- Insulin Sensitivity, Overweight or Obesity, Inflammatory Response
- Trial name
- PS (NCT04267705)
- Testing
- Control, Black bean, Chickpea
- Where
- United States
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Clinical Nutrition Research Center, Illinois Institute of Technology
Cardiometabolic Health, Healthy Aging
Impacts of Fruit on the Gut Health and Human Health
The objectives of this study are to investigate the effect of fruit consumption on the gut microbiota and their collective fecal and plasma metabolomes, vascular and cardiometabolic functions, cognition, and motor control.
- Conditions
- Cardiometabolic Health, Healthy Aging, Cognition
- Trial name
- NCT05063929
- Testing
- Fruit (2 cup eq), Fruit restriction (1/2 cup eq)
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- San Diego State University
Preterm Birth, Neurodevelopmental Disorders
Guangzhou Preterm and Term Birth Cohort Study
The Guangzhou Preterm-Term Birth Cohort (GPTBC) is a prospective observational study of how early-life nutrition, environmental exposures, and family factors relate to the health and development of preterm and term infants and…
- Conditions
- Preterm Birth, Neurodevelopmental Disorders, Overweight, Obesity
- Trial name
- GPTBC (NCT07756177)
- Testing
- No Intervention: Observational Cohort
- Where
- China
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Sun Yat-sen University
Human Immunodeficiency Virus, Chronic Hepatitis b
Gut Microbiome in People Living With HIV and HBV
Building a Microbiome Data Platform and Conducting Clinical Evidence Research in Individuals Infected with the Human Immunodeficiency Virus (HIV) and Hepatitis B virus.
- Conditions
- Human Immunodeficiency Virus, Chronic Hepatitis b, Gut Microbiome
- Trial name
- NCT06130137
- Volunteers
- 200 people
- Sponsor
- Kangbuk Samsung Hospital
Dietary Fiber, Gastrointestinal Microbiome
Luxembourgish Fiber Cohort
Many human populations across the world are deficient in the intake of dietary fiber. This decline in fiber consumption parallels an increase in prevalence of a multitude of diseases (e.g. colorectal cancer, multiple sclerosis).
- Conditions
- Dietary Fiber, Gastrointestinal Microbiome, Healthy Volunteers
- Trial name
- Lux-FiCo (NCT04352231)
- Testing
- High Fiber Diet Intervention, Low Fiber Diet Intervention
- Where
- 2 sites in Luxembourg
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Luxembourg Institute of Health
Malnutrition Pregnancy, Malnutrition in Children
Early Life Malnutrition, Environmental Enteric Dysfunction and Microbiome Trajectories
Malnutrition in women of reproductive age remains a public health concern in Sub-Saharan Africa (SSA). Malnutrition during pregnancy affects foetal growth with a tendency of the exposed infants to also develop it.
- Conditions
- Malnutrition Pregnancy, Malnutrition in Children, Malnutrition (Calorie), Environmental Enteric Dysfunction
- Trial name
- UZBCS-2 (NCT07195006)
- Testing
- Malnutrition in pregnancy as exposure, Poor WASH living conditions as exposure
- Where
- Zimbabwe
- Volunteers
- 368 people, healthy volunteers welcome
- Sponsor
- University of Zimbabwe
Changes in Human Gut Microbiome in Healthy Adults
Prospective Randomized Controlled Pilot Study of Gut Microbiome Modulation by Nigella Sativa Seed Oil and Thymoquinone Metabolism in Healthy Volunteers
For many patients, the additive use of dietary supplements without side effects is motivating for therapy and enhances quality of life.
- Trial name
- NCT07450807
- Testing
- Intake of Thymoquinone (TQ) containing Nigella Sativa Seed Oil (NSSO) capsules
- Where
- Germany
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Aysun Tekbaş
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
Dysbiosis, Clostridium Difficile
REMBRANDT: REcovery of the MicroBiome fRom Antibiotics for Dental implanTs
Antimicrobial therapy can lead to disruption of the gut microbiome and infection with Clostridioides difficile, a disease associated with high morbidity and mortality, particularly among the elderly.
- Conditions
- Dysbiosis, Clostridium Difficile, Pet-Human Bonding, Antibiotic-Associated Colitis
- Trial name
- NCT05622721
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- University of Pennsylvania
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