Clinical trials: Gastrointestinal Microbiota
Healthy
Pharmacokinetics and Bioavailability of Pomegranate Phenolics and Urolithins in Healthy Subjects.
Pomegranate phenolics (such as the ellagitannin punicalagin and ellagic acid) are metabolized by the human gut microbiota to yield a number of metabolites called urolithins (mainly Uro-A).
- Trial name
- POMEkinetics (NCT02056496)
- Testing
- Pomegranate extract
- Where
- Spain
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- National Research Council, Spain
Knee Arthroplasty, Total, Knee Osteoarthritis
Cementless Triathlon 5YR Follow-Up
All artificial joint implants need to be solidly held (fixed) within the bone. Cementless fixation has become a popular method to achieve fixation for total knee replacements where the bone grows directly onto the implanted…
- Conditions
- Knee Arthroplasty, Total, Knee Osteoarthritis, Radiostereometric Analysis
- Trial name
- NCT05877261
- Testing
- Cementless Total Knee Replacement
- Where
- Canada
- Volunteers
- 18 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Gut Microbiota
Effects of Riboflavin on Faecalibacterium Prausnitzii and the Gut Microbiota
The purpose of this trial is to investigate comprehensively the effect of riboflavin supplementation on the abundance of F. prausnitzii and on other members of the gut microbiota in faeces of healthy volunteers.
- Trial name
- NCT02929459
- Testing
- Riboflavin Dose 1, Riboflavin Dose 2
- Where
- Netherlands
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- dsm-firmenich Switzerland AG
Breast Cancer, HER-2 Positive Breast Cancer
Gut Microbiome Changes During Abemaciclib Therapy in Breast Cancer
Abemaciclib (Verzenio) is a commonly used treatment for hormone receptor-positive breast cancer, but it can cause gastrointestinal side effects such as diarrhea, which may affect quality of life and treatment tolerance.
- Trial name
- MICRO-VERZ (NCT07406594)
- Testing
- Resistant Potato Starch
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Vermont Medical Center
Human Microbiome
Oral Pomegranate Extract on the Microbiome and Skin Biophysical Properties
Pomegranate extract (Pomella) is well known for its antioxidant properties due to its phenolic compounds. It has also been shown to increase the amount of short chain fatty acid producing Lactobacillus and Bifidobacteria genera.
- Trial name
- NCT04596722
- Testing
- Pomella
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Integrative Skin Science and Research
Clostridium Difficile, Pseudomembranous Colitis
Fecal Microbiota Transplantation for Severe Clostridium Difficile Infection
Fecal microbiota transplantation (FMT) is acknowledged as a highly effective treatment for recurrent Clostridium difficile infection (CDI). Usually single fecal infusion achieves satisfactory cure rates of recurrent CDI).
- Trial name
- NCT03427229
- Testing
- Single-infusion FMT, Vancomycin (before randomization), multiple-infusion FMT
- Volunteers
- 58 people
- Sponsor
- Catholic University of the Sacred Heart
Gut Microbiome, Healthy Donors
Investigating the Impact of the Seaweed Derived Food Additive, Carrageenan, on the Human Gut Microbiome
The goal of this study is to investigate whether a seaweed derived food additive, carrageenan, has an impact on the human gut microbiome in vivo.
- Trial name
- NCT06738329
- Testing
- Carrageenan gummy sweet, Carrageenan and inulin gummy sweet
- Where
- United Kingdom
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- University of Reading
Asphyxia Neonatorum, Morbidity;Newborn
Effects of Probiotic Mixture Supplementation and Evaluation of Intestinal Mucosal Tolerance and Gut Microbiome in Newborns With Perinatal Asphyxia Receiving Hypothermic Treatment
The VISNAT trial is a PILOT STUDY due to absence of previous evidences in literature on using probiotic in newborns with perinatal asphyxia.
- Trial name
- VISNAT (NCT04145713)
- Testing
- Probiotic mixture
- Where
- Italy
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Policlinico Hospital
Renal Failure Chronic
Probiotics and Low Protein Diet in Advanced Chronic Kidney Disease
Here the investigators will perform a double-blinded randomized placebo-controlled clinical trial to evaluate the synergic effect of low protein diet and prebiotics in reducing the microbial inflammatory uremic toxins.
- Trial name
- ProLowCKD (NCT04204005)
- Testing
- Probiotics
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Probiotical S.p.A.
Obesity
Involvement of the Gut Microbiota-brain Cross-talk in the Loss of Eating Control
Overweight and obesity are increasingly prevalent worldwide. These bodyweight disorders are closely related to deficiencies in the control of food intake.
- Trial name
- GMBTalk-Food (NCT05646901)
- Where
- Spain
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Diet Habits, High-fibre Diet
Effects of High-Fiber Diet on Gut Microbiota, Metabolism, and Immune Microenvironment in Solid Tumor Patients: A Clinical Study
Cancer remains a major global public-health challenge and a central focus of medical research. According to the International Agency for Research on Cancer (IARC, 2020), 19.29 million new malignant tumors and 9.96 million cancer…
- Conditions
- Diet Habits, High-fibre Diet, Solid Tumor Cancer
- Trial name
- NCT07477522
- Testing
- High-fibre diet
- Where
- 2 sites in China
- Volunteers
- 17 people
- Sponsor
- West China Hospital
Oral Microbiota, Pancreatitis
The Characteristics of Oral Microbiota in Chronic Pancreatitis and Autoimmune Pancreatitis
There are more than 700 different bacteria colonized in human oral cavity, which are collectively referred to as oral microbiota.
- Conditions
- Oral Microbiota, Pancreatitis, Pancreatic Cancer
- Trial name
- NCT07015580
- Testing
- 16S rRNA sequencing
- Where
- China
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Ruijin Hospital
Clostridioides Difficile Infection
Clostridioides Difficile: Understanding Responses and Treatment Effects
The goal of this observational study is to learn how different treatments for Clostridioides difficile infection (CDI) work, and which biological mechanisms are involved in recovery.
- Trial name
- CURE-CDI (NCT07374094)
- Testing
- Antibiotic treatment, Fecal microbiota transplantation (FMT)
- Where
- Sweden
- Volunteers
- 200 people
- Sponsor
- Umeå University
Fractures, Bone, Infection, Bacterial
Gut Microbiome of Patients Undergoing Antibiotic Therapy for Orthopedic Device-related Infection
The microbiome of 80 orthopedic-device related infection (ODRI) patients treated with antibiotics and 10 healthy controls will be investigated. Samples (blood, stool, saliva, skin-swab) are collected 4x within 6 months.
- Conditions
- Fractures, Bone, Infection, Bacterial, Joint Infection, Bone Infection
- Trial name
- IMPAT-ODRI (NCT04440631)
- Testing
- no intervention, observational only
- Where
- 2 sites in Switzerland
- Volunteers
- 12 people
- Sponsor
- AO Research Institute Davos
Parkinson Disease, Irritable Bowel Syndrome
Early Signs of Parkinsons Disease in IBS
Bowel symptoms like constipation and abdominal pain are characteristic symptoms of irritable bowel syndrome (IBS). The pathogenesis and pathophysiology are not fully understood but subject to intense research, with emphasis on…
- Trial name
- NCT05573542
- Where
- Sweden
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Örebro University, Sweden
Obesity, Gastrointestinal Microbiome
Study on the Mechanism of Regulating Gut Microbiome in Obese People by Regulating Brain-gut Axis With Fast Diet
1. Normal diet：Starting from May 20, 2018, the subjects will eat a normal diet for 4 days, with no restriction on calories and food types. The subjects are required to record their daily diet and dietary intake of calories. 2.
- Conditions
- Obesity, Gastrointestinal Microbiome, Magnetic Resonance Imaging
- Trial name
- NCT04691583
- Testing
- Fast diet
- Where
- China
- Volunteers
- 35 people
- Sponsor
- Henan Provincial People's Hospital
Gut Microbiota, Epilepsy
MiCrobiota-gut-brain Axis in Resistant Epilepsy
Epilepsy is one of the most common neurological chronic conditions with a serious burden on patients, their caregivers, and society. Drug-resistant epilepsy (DRE) heightens this burden. New approaches are thus a priority.
- Conditions
- Gut Microbiota, Epilepsy, Drug-Resistant Epilepsy
- Trial name
- CARE (NCT07010445)
- Testing
- Naïve: epilepsy first diagnosis,, DRE-surgery: resective surgery;, anti-epileptic drugs;
- Where
- Italy
- Volunteers
- 120 people
- Sponsor
- Niguarda Hospital
Clostridium Difficile, Ulcerative Colitis
FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach
Clostridioides difficile infection (CDI) is the most frequent cause of infectious diarrhea in hospitalized patients and is responsible for 20-30 % of antibiotic-associated diarrhea cases.
- Trial name
- NCT06071312
- Testing
- single FMT, sequential FMT
- Where
- Italy
- Volunteers
- 64 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Metabolic Syndrome, Polycystic Ovary Syndrome
Combined Oral Contraceptive Pill and Resistance Starch
This study will enroll women with PCOS to study the effects of first line therapy, oral contraceptive pills, and then either 12 weeks of resistant starch or 12 weeks of placebo to explore if resistant starch improves…
- Trial name
- COR-PCOS (NCT06852365)
- Testing
- wheat dextrin, Oral Contraceptives, Low-Dose, Maltodextrin
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Pennsylvania
Helicobacter Infections
Levofloxacin Versus Clarithromycin Triple Therapy in First-Line Treatment for Helicobacter Pylori Eradication
Clarithromycin-based triple therapy containing a proton-pump inhibitor (PPI) twice daily, amoxicillin 1g twice daily, and clarithromycin 500 mg twice daily for 7 days is one of the standard firs-line therapy for Helicobacter…
- Trial name
- NCT00816140
- Testing
- Cravit based triple therapy, Klaricid based triple therapy
- Where
- Taiwan
- Volunteers
- 432 people, healthy volunteers welcome
- Sponsor
- National Taiwan University Hospital
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