Clinical trials: Intestinal Microbiome
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
Mechanisms, Defense
The Effect of Concord Grape Polyphenol-soy Protein Isolate Complex (GP-SPI) on Gut Microbiota
The overall purpose of this study is to evaluate the effect of nutritional supplementation with a well-characterized preparation of Concord grape polyphenol-soy protein isolate (GP-SPI) on the composition of the gut microbiota.
- Trial name
- NCT04018066
- Testing
- GP-SPI
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Rutgers, The State University of New Jersey
Crohn Disease, Pediatric Crohns Disease
Personalized AZithromycin/metronidAZole Therapy in Pediatric Crohn's Disease (CD)
This is a multi-center, randomized, controlled open-label add-on design trial pilot study to evaluate the efficacy of personalized adjunctive antibiotic (azithromycin + metronidazole) therapy in pediatric subjects with mild to…
- Trial name
- PAZAZ (NCT04186247)
- Testing
- Azithromycin, Metronidazole, Standard of Care
- Where
- 5 sites in United States, Canada and 2 more
- Volunteers
- 13 people
- Sponsor
- University of North Carolina, Chapel Hill
Healthy Volunteers
Evaluation of Changes to Skin Microbiome With Tape-Stripped Wounds
This single center, randomized, 15-day clinical trial is being conducted to assess the changes to the skin microbiome of induced wounds on the back in approximately 35 healthy adult subjects aged 18-55 years, with Fitzpatrick…
- Trial name
- NCT03365934
- Testing
- ADHESIVE BANDAGE #1, ADHESIVE BANDAGE #2, ADHESIVE BANDAGE #3
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
Gut Health
Investigation of the Effects of Dietary Fibres on the Gut Microbiome in a Transgenerational Cohort
Dietary fibres are complex carbohydrates present in fruit, vegetables, grains, and beans which are broken down into smaller molecules (short-chain fatty acids) in the colon by the gut microbiota.
- Trial name
- NCT05364437
- Testing
- Dietary Fibres Supplement, Cellulose Control
- Where
- United Kingdom
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Intestinal Bacteria Flora Disturbance
The Effect of Fruit/Vegetable Drinks on the Human Intestine
This is a 4 ½ week study with 20 healthy subjects (including a 2 week run-in ) . Subjects will be taking vegetable/fruit juice supplementation for 3 days.
- Trial name
- NCT02377063
- Testing
- Pressed Juice
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
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
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
Obesity, Morbid, Insulin Resistance
Stool Transplantation for Treatment of Insulin Resistance in Morbidly Obese Patients
More and more people in Canada and around the world are severely (morbidly) obese, and this is associated with a high risk for poor blood sugar control (insulin resistance, IR) and diabetes.
- Trial name
- NCT02970877
- Testing
- Fecal filtrate from 150 g stool from healthy lean donors, Fecal filtrate from 150 g of the recipient's own stool
- Where
- Canada
- Volunteers
- 29 people
- Sponsor
- Johane Allard
Healthy
Almonds: Digestive Health and Immune Function of Adults and Children
The purpose of this study is to determine whether incorporating almonds into the diets of families with young children will induce beneficial changes in gastrointestinal function, the fecal microbiota profile, and immune and…
- Trial name
- NCT01973595
- Testing
- Almonds, Then no almonds, No Almonds, Then almonds
- Where
- United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- University of Florida
Genital Tract Mucosal Immunity, Genital Tract Microflora
Study of Immune Cell Changes in the Genital Tract 2 Months After Initiation of an IUD for Contraception
This pilot study is being performed to investigate the influence that starting contraception with an IUD has on the local immune cell populations and features, with a particular focus on the cells and cell-surface features that…
- Trial name
- CHIC (NCT01240811)
- Testing
- IUD placement, Levonorgestrel IUD, Copper T380A IUD
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Sharon Achilles
Healthy Adults
Effect of Bismuth Subsalicylate on the Gut Microbiome and Host Response in Healthy Adults
Background: Many kinds of good or normal bacteria live on your skin and inside your stomach and intestines (gut). These bacteria are important to your health.
- Trial name
- NCT05930197
- Testing
- Bismuth subsalicylate
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy
Xanthohumol Metabolism and Signature
A pilot study to assess the safety and tolerability of oral xanthohumol in humans, to identify a biological signature of xanthohumol exposure, and to characterize the role of xanthohumol metabolism by intestinal microorganisms in…
- Trial name
- XMaS (NCT03735420)
- Testing
- Xanthohumol
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- National University of Natural Medicine
IBS - Irritable Bowel Syndrome
Irritable Bowel Syndrome and Control Volunteers: Diet Challenge
The purpose of this study is to study the relationship between the bile acids, short chain fatty acids and bacteria within the intestines.
- Trial name
- NCT03983434
- Testing
- Inulin
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Indiana University
Bacterial Microflora Reduction
Comparative Study of Antimicrobial Effectiveness
Comparative Study of Antimicrobial Effectiveness Evaluation of 26 ml Project X, 5.1ml Project X and Prevantics® Maxi Swabstick following ASTM E1173 - Standard Test Method for Evaluation of Preoperative, Precatheterization, or…
- Trial name
- NCT03817580
- Testing
- Project X 26ml, Project X 5.1ml, Prevantics Maxi Swabstick
- Where
- Romania
- Volunteers
- 170 people, healthy volunteers welcome
- Sponsor
- Professional Disposables International, Inc.
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
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
Irritable Bowel Syndrome
SH-DS01 on Fecal Metagenomic Stability
This is a randomized, double blind, Phase 1 study. There will be a 12-week comparison of the safety of DS-01 versus placebo with a secondary outcome measure of the efficacy in a cohort of 100 men or women with IBS with…
- Trial name
- NCT04598295
- Testing
- DS-01
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Beth Israel Deaconess Medical Center
Intestinal Microbiota and Barrier Function
Use of a Novel Synbiotic to Change Human Gut Bacteria and Improve Health in Obese Adults
This study evaluates the effect of a dietary supplement to improve gut health. The participants will take one of six dietary treatments for three weeks, and the gut bacteria and the gut intestinal barrier will be assessed to…
- Trial name
- NCT02355210
- Testing
- Bifidobacteria adolescentis BD1, Bifidobacteria animalis subsp. lactis BB-12, Bifidobacteria adolescentis BD1 and galactooligosaccharide
- Where
- United States
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- Rush University Medical Center
Ulcerative Colitis
Golimumab Effect in the Modulation of Gut Microbiota in Ulcerative Colitis
This study aims to characterize the changes on intestinal microbiota pattern associated with the use of golimumab in order to determine if intestinal microbiota markers may correlate with golimumab therapeutic effect in patients…
- Trial name
- GOLI2015 (NCT03018925)
- Testing
- Golimumab
- Where
- Spain
- Volunteers
- 15 people
- Sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta