Clinical trials: Gastrointestinal Microbiome
Enterocolitis, Necrotizing, Bacteremia
Antibiotic "Dysbiosis" in Preterm Infants
Prolonged antibiotic use in preterm neonates has significant consequences on the developing intestinal microbiome, metabolome and host response, predisposing the neonate to various major morbidities, including necrotizing…
- Conditions
- Enterocolitis, Necrotizing, Bacteremia, Bronchopulmonary Dysplasia, Intraventricular Hemorrhage
- Trial name
- NCT02784821
- Testing
- Antibiotic, Gastric fluid, Breast milk
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- University of Florida
Microbial Colonization
Effects of Intravenous (IV) Omadacycline on Gut Microbiome
Given the clinical need to improve upon current antibiotic regimens for the treatment of C. difficile infection with a particular focus on the impact of therapies on gut microbiome, this study proposes to characterize the impact…
- Trial name
- NCT05515562
- Testing
- Omadacycline Injection
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Wake Forest University Health Sciences
Human Gut Microbiota
Effects of Pre-, Pro- & Anti-biotics on Gut Microbiota
The purpose of this study is to compare and contrast the effects of a prebiotic (Trametes Versicolor), a probiotic (Saccharomyces boulardii) and an antibiotic (amoxicillin) on the gut microbiota of healthy volunteers.
- Trial name
- NCT01414010
- Testing
- Trametes versicolor extract, Saccharomyces boulardii, Amoxicillin
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Beth Israel Deaconess Medical Center
Melanoma (Skin), Melanoma
Pembrolizumab and EDP1503 in Advanced Melanoma
This study is being done to determine if orally administered EDP1503 will enhance the response to standard immunotherapy treatment (pembrolizumab) in participants with advanced melanoma.
- Trial name
- NCT03595683
- Testing
- Pembrolizumab, EDP1503
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- University of Chicago
Human Microbiome
Effects of Triphala and VSL#3 Probiotic Supplementation on Stool Microbiome Profiles and Inflammation
Normal aging can lead to loss of gut microbial biodiversity which is linked to inflammaging and immunosenescence or the loss of immunocompetence.
- Trial name
- TRIPH2017 (NCT03907501)
- Testing
- Synbiotic, Probiotic
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
Urea Cycle Disorder
Manipulating the Gut Microbiome Study
The objective is to determine if acetohydroxamic acid (AHA) can prevent hydrolysis of urea by inhibiting the bacterial urease of gut flora of both healthy control adults as well as adults with urea cycle disorders
- Trial name
- NCT03181828
- Testing
- Acetohydroxamic Acid Oral Tablet, No treatment
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Nicholas Ah Mew
Prematurity; Extreme, Feeding Disorder Neonatal
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
The central hypothesis of this clinical trial is that, in extremely preterm infants, protein-enriched human milk diets compared to usual human milk diets during the first 2 weeks after birth increase fat-free mass (FFM)-for-age Z…
- Conditions
- Prematurity; Extreme, Feeding Disorder Neonatal, Breast Milk Expression, Growth Failure
- Trial name
- NCT04325308
- Testing
- Protein-enriched human milk diet, Usual human milk diet
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Alabama at Birmingham
Obesity
A Pilot Trial of Nabilone for the Treatment of Obesity
Obesity is a serious health problem which increases the likelihood of developing other life-changing medical conditions. Despite increasing knowledge about the neural and metabolic basis of obesity, the development of effective…
- Trial name
- NCT04801641
- Testing
- Nabilone
- Where
- Canada
- Volunteers
- 18 people
- Sponsor
- Centre for Addiction and Mental Health
Sarcopenia, Inflammation
Effect of Fermented Milk Containing Lactobacillus Casei Strain Shirota in Sarcopenia Elderly
Sarcopenia, which refers to the progressive loss of skeletal muscle mass and strength, shares many characteristics with other disease states typically associated with risks of falling and fracture, including osteoporosis…
- Conditions
- Sarcopenia, Inflammation, Aging
- Trial name
- NCT04985877
- Testing
- Yakult 300 LIGHT Fermented Milk
- Where
- 3 sites in Taiwan
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- Taipei Medical University
Type 1 Diabetes
The Effect of Gluten-free Diet on New Onset Type 1 Diabetes (T1D)
The primary aim of this pilot study is to test whether gluten-free diet (GFD) instituted in children shortly after onset of Type 1 Diabetes (T1D) can decelerate the decline in beta cell function as compared to age matched…
- Trial name
- NCT02867436
- Testing
- Gluten-free diet
- Where
- 2 sites in Czechia
- Volunteers
- 45 people
- Sponsor
- University Hospital, Motol
Healthy Nutrition
Dietary Impact on Intestinal Sulfate Metabolism
This is a 5-week crossover pilot study of 15 highly motivated healthy volunteers who will consume two 7-day intervention diets: 1) a diet low in sulfur-containing amino acids (Low-S diet), emphasizing plant-based foods and fat…
- Trial name
- NCT05333900
- Testing
- Plant-Based Diet then animal-based diet, Animal-based diet then plant-based diet
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
Gastrointestinal Microbiome
Human Pilot Study - HA35 (Hyaluronan Molecular Weight 35) Dietary Supplement for Promoting Intestinal Health
The purpose of this study is to evaluate whether oral HA35 supplementation changes the normal intestinal bacteria, increases intestinal protection, decrease intestinal inflammation and permeability, and to assess any health…
- Trial name
- NCT02867605
- Testing
- Hyaluronan
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- The Cleveland Clinic
Nutritional and Metabolic Diseases
Evaluation of Potential Screening Tools for Metabolic Body Odor and Halitosis
This study is designed as a retrospective cohort study to evaluate the potential of diagnostic procedures in defining populations of patients self-reporting unexpected and uncontrollable episodes of body odor and/or halitosis.
- Trial name
- NCT02692495
- Where
- United Kingdom
- Volunteers
- 16 people
- Sponsor
- Mebo Research, Inc.
ESRD, Hyperkalemia
The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia
The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia (potassium greater than 5 milliequivalents per liter) is a non-randomized, crossover study.
- Conditions
- ESRD, Hyperkalemia, End Stage Renal Disease
- Trial name
- NCT03326583
- Testing
- Patiromer
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Dominic Raj
Helicobacter Pylori Infection
Comparing the Efficacy of Reverse Hybrid Therapy and Concomitant Therapy
Reverse hybrid therapy achieves a higher eradication rate than concomitant therapy remains unanswered.
- Trial name
- NCT02646332
- Testing
- (dexlan+amox+clar+metr)+(dexlan+amox), dexlan+clarith+amox+metro
- Where
- Taiwan
- Volunteers
- 248 people
- Sponsor
- Kaohsiung Veterans General Hospital.
Hypertension
Gut Butyrate and Blood Pressure in African Americans
African Americans have the greatest burden of hypertension. Recently, the short-chain fatty acid, butyrate, has been reported to have some effect on blood pressure.
- Trial name
- NCT04415333
- Testing
- Sodium Butyrate 5 mmol, Sodium Butyrate 80 mmol
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Iron-deficiency
Prebiotic GOS and Lactoferrin With Iron Supplements
The ultimate goal of this research is to develop a means to safely administer iron supplements to infants in settings with a high infection burden.
- Trial name
- NCT03866837
- Testing
- Galacto-oligosaccharides, Bovine lactoferrin, Multiple micronutrient powders with 5 mg iron
- Where
- 2 sites in Kenya, Switzerland
- Volunteers
- 288 people, healthy volunteers welcome
- Sponsor
- Columbia University
Cystic Fibrosis, Dysbiosis
Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis
The study will assess if administration of high-dose vitamin D and a commonly used prebiotic (inulin) is effective to reduce gastrointestinal dysbiosis and to improve critical intestinal functions in Cystic Fibrosis with the…
- Trial name
- NCT04118010
- Testing
- Vitamin D3, Inulin
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Emory University
Ulcerative Colitis
A Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects With Mild-to-Moderate Ulcerative Colitis
A Multiple Dose Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects with Mild-to-Moderate Ulcerative Colitis.
- Trial name
- NCT02618187
- Testing
- SER-287, Vancomycin Pre-Treat
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- Seres Therapeutics, Inc.
End-Stage Renal Disease, Gut Microbiome Dysbiosis
Gut Microbiome and p-Inulin in Hemodialysis
The Microbiome trial is a non-randomized, open-label, sequential, multi-center study of p-inulin for patients with hemodialysis-dependent end-stage renal disease.
- Trial name
- NCT02572882
- Testing
- p-inulin
- Where
- 4 sites in United States
- Volunteers
- 13 people
- Sponsor
- University of Pennsylvania