Clinical trials: Gastroenteritis Escherichia Coli
Diarrhea
The Protective Immune Response to Attenuated Enterotoxigenic Escherichia Coli Infection
The existing diarrhoeagenic Escherichia coli (E. coli) challenge model is already suitable for dietary interventions in its current form, targeted to impact on the immediate clinical symptoms upon E. coli infection.
- Trial name
- MIRRE (NCT03596827)
- Testing
- E. coli strain E1392-75-2A dose 1E10 CFU, E. coli strain E1392-75-2A dose 1E9 CFU, E. coli strain E1392-75-2A dose 1E8 CFU
- Where
- Netherlands
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- NIZO Food Research
Diarrhea Infectious
Study in Healthy Adults Challenged With Enterotoxigenic E. Coli, of the Safety, Tolerability and Anti-Diarrheal Activity of VENBETA6890, an Orally Administered, Human Monoclonal IgA
This is a phase 1, randomized, placebo-controlled, blinded study in up to 36 healthy adults, aged 18-45 years, challenged with Enterotoxigenic Escherichia coli, evaluating the safety, tolerability and anti-diarrheal activity of…
- Trial name
- MBL-ETEC-21-01 (NCT06896136)
- Testing
- VENBETA6890
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mark Klempner
Enteritis; Escherichia Coli, Enterotoxigenic
Challenge Study of an ETEC Vaccine
The purpose of the study is to determine the efficacy of a vaccine against enterotoxigenic E. coli (ETEC)-caused diarrhea.
- Trial name
- NCT01922856
- Testing
- LTR192G with dscCfaE, No Intervention
- Where
- 2 sites in United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Gastroenteritis, Bacterial Infection
The Effect of Probiotics on E. Coli Gastroenteritis
Background: The incidence of gastrointestinal infections is very high. In European countries 10-25% of the population suffers from at least one foodborne infection per year.
- Conditions
- Gastroenteritis, Bacterial Infection, Diarrhea
- Trial name
- PRETEC (NCT01225042)
- Testing
- probiotics
- Where
- Netherlands
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- NIZO Food Research
Shigella Sonnei Dysenteries
Safety, Immunogenicity and Efficacy Study of Inactivated Whole Cell Shigella Flexneri 2a Vaccine With and Without dmLT in Adults
This is a research study about an experimental (investigational) oral inactivated whole cell Shigella flexneri 2a killed vaccine (Sf2aWC) and an adjuvant called dmLT.
- Trial name
- NCT03038243
- Testing
- Shigella flexneri 2a whole cell (Sf2aWC) vaccine and double mutant E. coli heat labile toxin (dmLT), Shigella flexneri 2a whole cell (Sf2aWC) vaccine
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- PATH
Gastroenteritis Escherichia Coli
Phase 1 Study of dmLT ID Vaccination in Healthy Adults
This study is to determine the safety and immunogenicity of an Enterotoxigenic Escherichia coli (ETEC) candidate vaccine, attenuated recombinant Double Mutant Heat-Labile Toxin (dmLT) from ETEC, administered by the Intradermal…
- Trial name
- NCT02531685
- Testing
- Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Gastroenteritis Escherichia Coli
Safety and Immunogenicity of Peru-15-pCTB in Healthy Adult Subjects
Enterotoxigenic Escherichia (E.) coli (ETEC) bacteria are the main cause of traveler's diarrhea and are significant pathogens affecting children and elderly individuals of developing countries.
- Trial name
- NCT00654108
- Testing
- Ciprofloxacin, Peru-15-pCTB, Sodium bicarbonate/Ascorbic Acid/Aspartame Buffer
- Where
- United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Gastroenteritis Escherichia Coli
Phase I Study of ETEC Vaccine
The purpose of this study is to learn if a new candidate vaccine (dmLT) against ETEC (E. coli infection) is safe. This vaccine will be tested to see what effects it has on the body and the ability of the vaccine to help the body…
- Trial name
- NCT01147445
- Testing
- Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine
- Where
- 2 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Gastroenteritis, Bacterial Infection
The Effect of Probiotics on E. Coli-induced Gastroenteritis
Background: The incidence of gastrointestinal infections is very high. In Western countries at least 30% of the population suffers from at least one food-borne infection per year.
- Conditions
- Gastroenteritis, Bacterial Infection, Diarrhea
- Trial name
- PROTETEC (NCT01709266)
- Testing
- Probiotics
- Where
- Netherlands
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- NIZO Food Research
Gastroenteritis Escherichia Coli
Safety of Sublingual dmLT for ETEC
A Phase 1 dose escalating study of ETEC candidate vaccine to determine safety and immunogenicity of a multi-dose regimen in healthy adult volunteers.
- Trial name
- NCT02052934
- Testing
- Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Crohn's Disease, Ulcerative Colitis
Proteomic Analysis of Crohn's Disease Macrophages in Response or Not to AIEC
The M2iSH laboratory showed with two previous clinical trials that Crohn's Disease (CD) macrophages present i) a defect to control Adherent-Invasive Escherichia coli (AIEC) infection related to polymorphisms associated with CD…
- Trial name
- ROMAN (NCT03404557)
- Testing
- Proteomic analysis
- Where
- France
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- University Hospital, Clermont-Ferrand
Diarrhea, Gastroenteritis
Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli
Although the existing diarrhoeagenic Escherichia coli (E. coli) challenge model is already suitable for dietary interventions in its current form, further characterization of the working-mechanism of the attenuated strain and…
- Conditions
- Diarrhea, Gastroenteritis, Bacterial Infections, Escherichia Coli Infections
- Trial name
- CORAL (NCT02541695)
- Testing
- E. coli strain E1392-75-2A
- Where
- 2 sites in Netherlands
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- NIZO Food Research
Diarrhea, Travelers Diarrhea
Clinical Study to Assess the Efficacy of Once-daily IMM-124E (Travelan®) in a Controlled Human Infection Model.
This is a randomized, double-blind, placebo-controlled study to investigate a single daily dose of Travelan® protects healthy adult volunteers from moderate-to-severe diarrhea upon challenge with Enterotoxigenic Escherichia coli…
- Conditions
- Diarrhea, Travelers Diarrhea, Infectious Diarrhea
- Trial name
- NCT05933525
- Testing
- Travelan
- Where
- United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Immuron Ltd.
Weight Gain, Anemia, Iron Deficiency
Egg Intervention During Pregnancy in Indonesia
The study consists of two arms: 1) intervention group using eggs as supplementary food given from 2nd trimester of pregnancy to birth, and 2) observational group of pregnant mothers.
- Conditions
- Weight Gain, Anemia, Iron Deficiency, Birth Weight, Birth Length
- Trial name
- PRECODE (NCT04694235)
- Testing
- Egg intervention
- Where
- Indonesia
- Volunteers
- 702 people, healthy volunteers welcome
- Sponsor
- SEAMEO Regional Centre for Food and Nutrition
Diarrhea
Rifaximin for Prevention of Travellers' Diarrhea
The purpose of this study is to determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo.
- Trial name
- NCT00742469
- Testing
- Rifaximin
- Where
- Mexico
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Crohn Disease
Safety and Efficacy of EcoActive on Intestinal Adherent Invasive E. Coli in Patients With Inactive Crohn's Disease
This study will evaluate the safety of oral administration of EcoActive to patients with inactive Crohn's disease and how it affects the levels of AIEC in stool.
- Trial name
- NCT03808103
- Testing
- Bacteriophage preparation
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Intralytix, Inc.
Crohn's Disease
MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients
The study is a multicenter, international descriptive study with a bio-collection in 300 evaluable Crohn's disease patients to be processed after usual biological tests via bioinformatics tools.
- Trial name
- MOBIDIC (NCT02882841)
- Testing
- Biopsies, stool and blood collection
- Where
- 3 sites in United States, France and 1 more
- Volunteers
- 143 people
- Sponsor
- Enterome
Dysentery
Identification of Correlates of Protection Against Shigella and Enterotoxigenic Escherichia Coli Infections
The aim of this study is to accelerate the development of vaccine candidates against diarrheal diseases caused by Shigella and Enterotoxigenic Escherichia coli (ETEC).
- Trial name
- NCT01638039
- Testing
- Laboratory Tests
- Where
- 7 sites in Israel
- Volunteers
- 330 people, healthy volunteers welcome
- Sponsor
- Hillel Yaffe Medical Center
Gastroenteritis Escherichia Coli, Immunisation
A Double-Blind Placebo-Control Dose Escalating Study to Evaluate the Safety and Immunogenicity of dmLT by Oral, Sublingual and Intradermal Vaccination in Adults Residing in an Endemic Area
This is a trial to evaluate the safety and immunogenicity of double mutant heat-labile toxin LTR192G/L211A (dmLT) from Enterotoxigenic Escherichia coli (ETEC) by oral, sublingual, or intradermal vaccination in approximately 135…
- Trial name
- NCT03548064
- Testing
- Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine
- Where
- 2 sites in United States, Bangladesh
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy Volunteer
Efficacy of B7A BSIgG Against E. Coli Strain B7A Challenge
Enterotoxigenic Escherichia coli (ETEC) is a major cause of diarrhea worldwide. Vaccines and therapeutics are under development to prevent ETEC disease in children and travelers.
- Trial name
- NCT03040687
- Testing
- Anti CS6 BSIgG product (Lot PD1601105CS), Anti B7A BSIgG product (Lot PD1601132ET), Bovine Immunoglobin Negative Control (Lot PD161071NC)
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health