Clinical trials: Stool Microbiome
Rotavirus Infections, Reaction - Vaccine Nos
Does the Fecal Microbiome Influence Rotarix Immunogenicity
This is a proposal for a nested case-control study within an ongoing rotavirus vaccine immunogenicity clinical trial Karachi, Pakistan.
- Conditions
- Rotavirus Infections, Reaction - Vaccine Nos, Intestinal Bacteria Flora Disturbance
- Trial name
- NCT02220439
- Volunteers
- 76 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Pre Diabetic
A Pilot Study to Determine the Effect of a Cobiotic Formulation on the Gastrointestinal Microbiome
This study aims to investigate the effect of a cobiotic formulation, prepared as a smoothie beverage, on the ratio of intestinal microbiota of the Bacteroidetes phylum to those of the Firmicutes phylum in the stool as well as the…
- Trial name
- NCT01724736
- Testing
- NM504:
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- NuMe Health
Unresectable or Metastatic Advanced Pancreatic Ductal Adenocarcinoma
CHemotherapy And Stool Transplant in PDAC (CHASe-PDAC)
To confirm the safety of combining oral fecal microbiota transplantation (FMT) with gemcitabine and nab-paclitaxel chemotherapy as first line treatment in patients with unresectable or metastatic pancreatic ductal adenocarcinoma.
- Trial name
- CHASe-PDAC (NCT06393400)
- Testing
- Fecal Microbiota Transplantation, PEG3350, Gemcitabine
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- John Lenehan
General Population (no Specific Condition or Disease)
Collection of Stool From Healthy Donors for the ex Vivo Study of Shifts of Microbiome Induced by Dairy Phages and Antibiotics: a Model of Bacteria/Host Interaction (DAIRY-SHAPE)
The gut microbiota plays a crucial role in health through its involvement in pathogen defense, immune regulation, and nutrient digestion.
- Trial name
- DAIRY-SHAPE (NCT07212400)
- Where
- France
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Melanoma
Assessing the Tolerance and Clinical Benefit of feCAl tranSplantation in patientS With melanOma
Recent studies suggest that patients with metastatic melanoma whose gut microbiome is colonized by eubiotic bacteria have a stronger anti-cancer response to anti CTLA-4 and anti PD1.
- Trial name
- PICASSO (NCT04988841)
- Testing
- MaaT013, Ipilimumab, Nivolumab
- Where
- 5 sites in France
- Volunteers
- 70 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Gastric Cancer, Colorectal Cancer
Oral, Fecal and Intratumoral Microbiome Atlas in Colombian Patients With Advanced Solid Tumors Receiving First-Line Immunotherapy
This is a prospective observational cohort study conducted at Fundación CTIC in Bogotá, Colombia. It characterizes the oral, fecal and intratumoral microbiome of Colombian adults with advanced solid tumors (gastric, colorectal…
- Conditions
- Gastric Cancer, Colorectal Cancer, Breast Cancer, Cervical Cancer
- Trial name
- ATLAS (NCT07676461)
- Testing
- First-line immunotherapy (immune checkpoint inhibitors), INVIMA-approved, standard of care
- Where
- Colombia
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo
Ulcerative Colitis
Prediction of Dietary Intervention Efficacy in Mild Ulcerative Colitis Patients Based on Fecal Microbiome Signatures
A double-blind randomized placebo-controlled parallel trial with two intervention arms and two placebo arms and a period of eight intervention weeks to validate the prediction that prebiotics could induce a higher response in…
- Trial name
- PREDUCTOME (NCT05579483)
- Testing
- Prebiotics
- Where
- Netherlands
- Sponsor
- Wageningen University
Parkinson's Disease
Characterization of Fecal Microbiome Changes After Administration of PRIM-DJ2727 in Parkinson's Disease Patients
The purpose of this study is to characterize the intestinal flora in subjects with Parkinson's Disease (PD) and to determine safety and trends in improvements in diversity of colonic microbiome following fecal microbiota…
- Trial name
- NCT03026231
- Testing
- PRIM-DJ2727
- Sponsor
- The University of Texas Health Science Center, Houston
Gut Microbiota
To Investigate the Effect of Arabinogalactan on the Gut Microbiome in Adults
Dietary fiber is an important nutrient that supports gastrointestinal function, as well as the maintenance of blood glucose and cholesterol.
- Trial name
- NCT04351841
- Testing
- arabinogalactan, maltodextrin
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Biofortis, Merieux NutriSciences
Major Depressive Disorder (MDD), Depression - Major Depressive Disorder
Assessment of the Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Patients With Major Depressive Disorder
This study aimed to evaluate the efficacy and safety of fecal microbiota transplantation (FMT) in patients with major depressive disorder (MDD) who exhibit suboptimal early response to antidepressant treatment.
- Trial name
- NCT06692361
- Testing
- FMT capsule, Escitalopram (Lexapro), Corn Starch capsules
- Where
- 9 sites in China
- Volunteers
- 214 people
- Sponsor
- Gang Wang
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
Autism Spectrum Disorder
Fecal Microbiota Transplantation in Children With ASD
This is a single-center, randomized, double-dummy, triple-blind, placebo-controlled, three-arm parallel-group superiority trial.
- Trial name
- NCT07381374
- Testing
- ctive FMT via Nasojejunal Tube (FMT-Upper GI), Active FMT via Colonoscopy and Transendoscopic Tube (FMT-Lower GI)
- Where
- China
- Volunteers
- 1 people
- Sponsor
- Shenzhen Children's Hospital
Pouchitis
Safety and Efficacy of Fecal Microbiome Transplantation (FMT) in the Treatment of Antibiotic Dependent Pouchitis (ADP)
Antibiotic dependent pouchitis (ADP) is predestined to benefit from FMT, since bacterial dysbiosis, which can only be controlled with antibiotics, appears to be the major driver of the clinical symptoms.
- Trial name
- NCT02782325
- Testing
- Active FMT, then open label FMT
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of North Carolina, Chapel Hill
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
Non-Alcoholic Fatty Liver Disease, Probiotics MeSH Descriptor Data 2018
Effects of Probiotic on Inflammation and Microbiota in Patients With NASH
Individuals with clinically identified non-alcoholic fatty liver disease will undergo baseline evaluation of IL-17 and other inflammatory markers as well as microbiome determination.
- Conditions
- Non-Alcoholic Fatty Liver Disease, Probiotics MeSH Descriptor Data 2018, Interleukin-17 MeSH Descriptor Data 2018
- Trial name
- NASHPro (NCT03511365)
- Testing
- Probiotic Formulation VSL#3
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Northwell Health
Body Weight
Pulse Biomarker Discovery
Dietary pulses, including beans, chickpeas, and lentils, are high in soluble fiber with potential benefits to human health: Pulses are moderate energy density foods, low in fat and high in dietary protein, fiber, vitamins and…
- Trial name
- NCT04887584
- Testing
- Control diet, Low Pulse diet, High Pulse diet
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- USDA, Western Human Nutrition Research Center
Inflammatory Bowel Diseases, Microbiota
Evaluation of the Diagnostic Potential of Artificial Intelligence-assisted Fecal Microbiome Testing for Inflammatory Bowel Disease
The goal of this clinical trial is to evaluate the diagnostic potential of Artificial Intelligence-assisted Fecal Microbiome Testing for the diagnosis of inflammatory bowel disease.
- Conditions
- Inflammatory Bowel Diseases, Microbiota, Colonoscopy
- Trial name
- NCT05797207
- Testing
- Artificial Intelligence-assisted Fecal Microbiome Testing, Colonoscopy
- Where
- Turkey (Türkiye)
- Volunteers
- 300 people
- Sponsor
- Istanbul Medipol University Hospital
Microbiome, Plasma Cholesterol
The Effect of Oats Containing 1.4g Beta Glucan on Fecal Bacterial Population(s) and Plasma Cholesterol in Healthy Adults With Elevated Cholesterol Levels
The objectives of this study are to examine fecal bacterial population(s) and plasma cholesterol levels elicited by 40g of Oats and Cream of Rice over 6 weeks.
- Conditions
- Microbiome, Plasma Cholesterol, Prebiotic
- Trial name
- NCT03450395
- Testing
- Hot Cereal
- Where
- Ireland
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- PepsiCo Global R&D
Fecal Microbiota Transplantation, Crohn Disease
Microbial Restoration in Inflammatory Bowel Diseases
This is a prospective, two-centre, double-blind, parallel-arm, randomised, placebo-controlled trial evaluating the impact of FMT on patients with active Crohn's disease.
- Conditions
- Fecal Microbiota Transplantation, Crohn Disease, Inflammatory Bowel Diseases, Microbiome
- Trial name
- MIRO II (NCT04970446)
- Testing
- Antibiotics, Dietician designed diet, FMT
- Where
- Australia
- Volunteers
- 120 people
- Sponsor
- St Vincent's Hospital Melbourne
Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD)
AIM-IBD: A Microbiome-Targeted Supplement in Mild-to-Moderate Ulcerative Colitis
This Phase 2b randomized, double-blind, placebo-controlled, multicenter trial will evaluate the efficacy and safety of a once-daily oral microbiome-targeted food supplement compared with matching placebo in adults with…
- Conditions
- Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD), Colitis
- Trial name
- AIM-IBD (NCT07619638)
- Testing
- Microbiome-Targeting Nutraceutical
- Where
- Turkey (Türkiye)
- Volunteers
- 162 people
- Sponsor
- ENBIOSIS BIOTECHNOLOGIES