Clinical trials: Gastrointestinal Microbiota
Vaccine Response Impaired, Vaccine Adverse Reaction
Vaccine Observation to Include All Communities for Equitable Science
VOICES is a longitudinal, prospective, observational study that will enroll up to 10,000 subjects of diverse racial backgrounds being administered an emergency use authorized COVID-19 vaccine, for collection and analysis of stool…
- Trial name
- VOICES (NCT04770649)
- Testing
- COVID-19 vaccine
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Persephone Biosciences
Metabolic Effects, Immunosuppressive Agents
Impact of SCFA Supplementation on Gut Microbiome Composition of Kidney Transplant Recipients
This is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effects of high-dose short-chain fatty acid (SCFA) supplementation on the gut microbiome and host metabolome in stable kidney…
- Conditions
- Metabolic Effects, Immunosuppressive Agents, Renal Function, Adverse Events
- Trial name
- RENOBIOME (NCT07024238)
- Testing
- SCFA
- Where
- Slovakia
- Volunteers
- 41 people
- Sponsor
- University Hospital, Martin
Sleep Problem, Neurobehavioral Manifestations
NapBiome: Targeting Gut Microbiota and Sleep Rhythm to Improve Developmental and Behavioral Outcomes in Early Childhood
The gut-brain axis plays a crucial role in the regulation and development of psychological and physical processes. The first year of life is a critical period for the development of the gut microbiome, which parallels important…
- Trial name
- NapBiome (NCT06396689)
- Testing
- Synbiotic
- Where
- 2 sites in Switzerland
- Volunteers
- 380 people, healthy volunteers welcome
- Sponsor
- Petra Zimmermann
Diabetes, Heart Diseases
PREDICT 2: Personalized Responses to Dietary Composition Trial 2
Foods in the human diet can affect the development of diseases over time, such as diabetes or heart disease. This is because the amount and types of foods in the diet eat can affect a person's weight, and because different foods…
- Conditions
- Diabetes, Heart Diseases, Diet Habit, Diet Modification
- Trial name
- NCT03983733
- Testing
- Dietary Intervention
- Where
- United States
- Volunteers
- 1,139 people, healthy volunteers welcome
- Sponsor
- Zoe Global Limited
Metabolic Dysfunction-Associated Steatotic Liver Disease Infant Development
TUDCA in High-Risk Lactating Mothers Identified by Early Postpartum Milk Hydrophobicity Index
This is a randomized, double-blind, placebo-controlled Phase 2 proof-of-concept trial in mother-infant dyads. The study aims to evaluate the safety, tolerability, and biological effects of maternal oral tauroursodeoxycholic acid…
- Trial name
- MILK-HI-TUDCA (NCT07517276)
- Testing
- tauroursodeoxycholic acid (TUDCA)
- Volunteers
- 80 people
- Sponsor
- Peking University First Hospital
Immune Modulation
Short-term Immunomodulatory Effects of Lactobacillus Casei DN-114001: Impacts on Gut Microbiota Composition and Systemic Immune Biomarkers in Healthy Adults
The study included 21 adult participants, aged 19-46 years (19 female participants and 2 male participants). The selection criteria included the following parameters: Body Mass Index (BMI), calculated as weight (kg) divided by…
- Trial name
- NCT06747143
- Testing
- Lactobacillus casei DN-114001
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- University of Valladolid
Advanced RCC
Gut Microbiota Modulation for Immunotherapy Resensitization in Advanced Renal Cell Carcinoma
The combination of immune checkpoint inhibitors (ICIs) and tyrosine kinase inhibitors (TKIs) has significantly improved clinical outcomes in patients with advanced renal cell carcinoma (RCC).
- Trial name
- REMEDY-RCC (NCT07611825)
- Testing
- Toripalimab, Ipilimumab
- Where
- 2 sites in China
- Volunteers
- 33 people
- Sponsor
- Jinling Hospital, China
Upper Respiratory Tract Infection, Gut Microbiota
The Effect of Synbiotics on the Upper Respiratory Tract Infection
Gut microbiome manipulation to alter the gut-lung axis may potentially protect humans against respiratory infections. However, clinical trials of synbiotics, one of the microbiota-targeted intervention, in this regard is few.
- Conditions
- Upper Respiratory Tract Infection, Gut Microbiota, Immune Function
- Trial name
- NCT04960878
- Testing
- Synbiotic
- Where
- China
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Huazhong University of Science and Technology
Antibiotic Side Effect, Antibiotic-associated Diarrhea
Metagenomic and Metabolomic Reconstitution of Gut Microbiota After Broad Spectrum Antibiotic Therapy
In the United States, healthcare providers prescribe over 270 million antibiotic prescriptions each year. While antibiotics have transformed medicine and methods of treating life-threatening bacterial infection, broad spectrum…
- Conditions
- Antibiotic Side Effect, Antibiotic-associated Diarrhea, Antibiotic-induced Dysbiosis, Antibiotic-induced Epithelial Barrier Disintegrity
- Trial name
- NCT04171466
- Testing
- Ciprofloxacin + Metronidazole, SH-DS01
- Where
- Canada
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Seed Health
Type 2 Diabetes
Assessing Gut Microbiome Changes Before and After an Oral Nutritional Supplement Intake Using the SIMBA Capsule in Diabetic Participants
This is a single-arm interventional clinical study, the primary objective is to assess the changes in the small intestinal (SI) metagenomic profile of in diabetic participants from baseline to midpoint and endpoint in response to…
- Trial name
- NCT06704022
- Testing
- Oral nutritional supplement
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- Nimble Science Ltd.
Gastrointestinal, Microbiota
Open-Label Clinical Trial Evaluating the Impact of a Multi-Strain Commensal Probiotic Dietary Supplement on Gastrointestinal Microbiota Composition, Functional Gastrointestinal Markers, and Gastrointestinal Symptoms
A single-arm, open-label prospective study will be conducted evaluating the impact of 8 weeks of supplementation at the manufacturer-recommended dose of Complete Commensal Probiotic™ on the GI-MAP stool test panel (Diagnostic…
- Trial name
- NCT07720362
- Testing
- Complete Commensal Probiotic
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- OvationLab
Non-Alcoholic Fatty Liver Disease
Aronia and Non-alcoholic Fatty Liver Disease
Adults newly diagnosed with NAFLD will be included in the study. At the beginning of the research, the socio-demographic characteristics and nutritional habits of the individuals will be questioned with a face-to-face…
- Trial name
- NCT06450769
- Testing
- Aronia juice, Mediterranean diet, Low-fat diet
- Volunteers
- 54 people
- Sponsor
- Istanbul Kent University
End Stage Renal Disease, Gut Microbiome Dysbiosis
Prebiotics in Peritoneal Dialysis
The Prebiotics in Peritoneal Dialysis trial is a non-randomized, open-label, crossover study of p-inulin for patients with end-stage renal disease treated with peritoneal dialysis.
- Trial name
- NCT03265639
- Testing
- P-inulin
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- Ali Ramezani
Liver Cirrhosis
Implications of Fecal Microbiota Transplantation in Modulating the Effects of Liver Cirrhosis
The study aims to investigate the beneficial effects of fecal transplantation in patients diagnosed with liver cirrhosis (regardless of etiology).
- Trial name
- NCT06478602
- Testing
- Fecal microbiota transplantation
- Where
- Romania
- Volunteers
- 19 people
- Sponsor
- Cristian Ichim
Post-infective Bowel Dysfunction, Functional Gastrointestinal Disorders
Campylobacter Enteritis and PI-BD: Dietary Reduction in Carbohydrates
The purpose of the study is explore the issues that relate to testing a particular dietary treatment, the low FODMAP diet, in a randomised trial using an appropriate control diet with which to compare it.
- Trial name
- CEDRIC (NCT02232373)
- Testing
- low FODMAP dietary advice, Maltodextrin, Oligofructose
- Where
- United Kingdom
- Volunteers
- 9 people
- Sponsor
- University of Nottingham
Cognitive Function and Mood, Cerebral Blood Flow
The Effects of Resveratrol Supplementation on Cognition, Cerebral Blood Flow, Microbiota and Systemic Inflammation.
Previous research shows that a diet high in fat has harmful effects on gut health. This increases the chance of developing obesity-related diseases (such as type 2 diabetes) and disrupts cognition and mood.
- Conditions
- Cognitive Function and Mood, Cerebral Blood Flow, Systemic Inflammation, Gut Microbiota
- Trial name
- NCT03448094
- Testing
- Resveratrol
- Where
- United Kingdom
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Northumbria University
Healthy Aging, Anti Aging
iVS-1 Probiotic Intervention Targeting Biological Aging in Midlife Adults
This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effects of Bifidobacterium adolescentis (iVS-1) supplementation on biological aging markers, metabolic health, and functional…
- Trial name
- VITAL (NCT07407894)
- Testing
- Bifidobacterium adolescentis iVS-1
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Synbiotic Health
Renal Failure, Hepatic Failure
The Role of Skin Microbiota in Hepatic or Renal Pruritus
Various neurotransmitters may share in the pathogenesis of hepatic and renal itching. Skin microbiota may share in the pathogenesis of pruritus.
- Conditions
- Renal Failure, Hepatic Failure, Pruritus
- Trial name
- NCT05604469
- Testing
- Isolation of skin microbiota
- Where
- Egypt
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Zagazig University
Obesity, Insulin Resistance
Probiotics on Body Composition and Insulin Resistance in Patients With Obesity and Its Association With Gut Microbiota
This study aims to evaluate the modifications in body composition and insulin resistance state in patients with grade II and III obesity included in an interventional lifestyle changes program and treated with probiotics (1 x…
- Conditions
- Obesity, Insulin Resistance, Microbial Colonization
- Trial name
- NCT04086173
- Testing
- Probiotics
- Where
- Mexico
- Volunteers
- 80 people
- Sponsor
- Hospital General de México Dr. Eduardo Liceaga
Prebiotic, IBS (Irritable Bowel Syndrome)
Psyllium Husk in Pediatric IBS
Children aged 6 to 17 years with IBS will be randomly assigned to either receive psyllium husk supplementation in addition to usual care or receive usual care alone.
- Conditions
- Prebiotic, IBS (Irritable Bowel Syndrome), Psyllium, Quality of Life (QOL)
- Trial name
- NCT07880327
- Testing
- Psyllium Husk, Conventional therapy group
- Volunteers
- 70 people
- Sponsor
- Eman ElHaddad
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