Clinical trials: Infectious Diarrhea
Diarrhea
Prevention of Diarrheal Disease Due to Infection With Enterotoxigenic E. Coli (ETEC)
This is a Phase II b, double-blind, randomized, placebo-controlled study in healthy adults (age 18-65 years) to evaluate the safety, immunogenicity, different diagnostic tools and efficacy of ETVAX.
- Trial name
- NCT03729219
- Testing
- E. coli ETVAX
- Where
- Finland
- Volunteers
- 749 people, healthy volunteers welcome
- Sponsor
- Scandinavian Biopharma AB
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
Shigellosis
Safety Study of Inactivated Shigella Whole Cell Vaccine in Adults
This is a research study about an experimental (investigational) oral inactivated whole cell Shigella flexneri 2a killed vaccine (Sf2aWC).
- Trial name
- NCT01509846
- Testing
- Vaccine: 2.6±0.8 x 10^8 vp/mL, 1 dose, Vaccine: 2.6±0.8 x 10^9 vp/mL, 3 doses, Vaccine: 2.6±0.8 x 10^10 vp/mL, 3 doses
- Where
- 2 sites in United States
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- PATH
Shigellosis
A Phase 1, Dose Escalation Study, to Evaluate a New Shigella Sonnei Vaccine in Healthy Adults.
This Phase 1 clinical trial is aimed to evaluate the safety and immunogenicity of 3 doses of 5 sequentially escalating dosages of a candidate vaccine against Shigella sonnei (1790GAHB vaccine) administered by intramuscular route…
- Trial name
- NCT02017899
- Testing
- S. sonnei 1790GAHB
- Where
- France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GSK Vaccines Institute For Global Health S.r.l.
Shigellosis
Phase 2b Challenge Study With the Bioconjugate Vaccine Flexyn2a
In this proof of concept challenge study, the bioconjugate candidate vaccine Flexyn2a will be tested for its ability to induce an immune response that protects healthy adult volunteers from infection with a wild-type Shigella…
- Trial name
- NCT02646371
- Testing
- Flexyn2a
- Where
- United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- LimmaTech Biologics AG
Cholera, Diarrhoea
Study of Alternative Vaccination Schedule of Oral Cholera Vaccine
The absence of a boosting response after a 14 day interval with the two-dose regimen of the modified killed oral cholera vaccine raises the possibility that a longer dosing interval may be required to observe a boost in the…
- Conditions
- Cholera, Diarrhoea, Vibrio Infection
- Trial name
- NCT01233362
- Testing
- Modified killed oral cholera vaccine at 14 day interval, Modified killed oral cholera vaccine at 28 day interval
- Where
- India
- Volunteers
- 386 people, healthy volunteers welcome
- Sponsor
- International Vaccine Institute
Diarrhea
Invaplex 50 Vaccine Dose-Ranging
The vaccine is given as a nose spray. Volunteers will receive a 3-dose vaccination with doses spaced two weeks apart. Volunteers will be assigned to a vaccination group based on their order of enrollment with consideration of…
- Trial name
- NCT00082069
- Testing
- Shigella flexneri 2a Invaplex 50
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Dysentery, Dysentery, Bacillary
Safety Study of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months
The purpose of this study is to evaluate safety of S.flexneriza-S.sonnei Bivalent Conjugate Vaccine in healthy volunteers aged above 3 Months.
- Trial name
- NCT03561181
- Testing
- S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine
- Where
- China
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Shigella
Safety, and Efficacy Study of ShigETEC, a Live, Attenuated, Oral Combination Vaccine to Prevent Shigella and ETEC Disease Delivered to Healthy Adults Ages 18 to 50 Years Old
The purpose of this study is to evaluate the efficacy of the oral, live, attenuated ShigETEC vaccine against challenge with S. flexneri 2457T.
- Trial name
- NCT07049159
- Testing
- ShigETEC vaccine, Challenge: Shigella flexneri 2457T at a dose of 1.5x10^3 CFU
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Eveliqure Biotechnologies GmbH
Enterotoxigenic Escherichia Coli Infection, Diarrhea
Study Confirming A Human Challenge Model and Investigating The Safety Of VLA1701
This is a single-center, double-blind, placebo-controlled, Phase II vaccination and challenge study designed to confirm a human challenge model with E. coli strain LSN03-016011/A.
- Trial name
- NCT03576183
- Testing
- VLA1701, Challenge Strain
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Valneva Austria GmbH
Diarrhea Infectious
Immunological Characteristics of a Population at Risk of Cholera After Oral Cholera Vaccine (CHOVAXIM)
The purpose of the study is to find out if individuals who received first and second dose of Oral Cholera Vaccine (OCV) in Lukanga Swamps, Central Province of Zambia have developed protection against future attacks to cholera.
- Trial name
- CHOVAXIM (NCT04423159)
- Testing
- OCV Vaccine
- Where
- Zambia
- Volunteers
- 225 people, healthy volunteers welcome
- Sponsor
- Centre for Infectious Disease Research in Zambia
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
Diarrhoea
A Study on the Immune Response and Safety of a Multicomponent Shigella Vaccine in Preventing Shigellosis in Infants
This study evaluates the immune response and safety of a multicomponent, 2-dose Shigella vaccine in preventing shigellosis in African infants.
- Trial name
- NCT06663436
- Testing
- altSonflex1-2-3 Dose A, altSonflex1-2-3 Dose B, altSonflex1-2-3 Dose C
- Where
- Kenya
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Shigellosis
Safety and Efficacy of the Bacteriophage Preparation, ShigActive™, in a Human Experimental Model of Shigellosis
The study is a first-in-human Phase 1/2a randomized, double-blind, placebo-controlled trial to assess the clinical safety and efficacy of ShigActive in healthy adults with experimental Shigella challenge.
- Trial name
- NCT05182749
- Testing
- bacteriophage
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Intralytix, Inc.
Shigellosis
A Study to Determine If a New Shigella Vaccine is Safe, Induces Immunity and The Best Dose Among Kenyan Infants
In this study, the tetravalent bioconjugate candidate vaccine Shigella4V will be tested to obtain first-in-human data on its safety and immunogenicity in infants and to identify the preferred dose of Shigella4V in 9 month old…
- Trial name
- NCT04056117
- Testing
- Shigella 4V, MenACWY, Rabies
- Where
- 2 sites in Kenya
- Volunteers
- 597 people, healthy volunteers welcome
- Sponsor
- LimmaTech Biologics AG
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
Dysbiosis
A Pilot Study Assessing Intestinal Microbiota Diversification and Changes After Travel to South(East) Asia From the US
This prospective, observational pilot study is designed to assess feasibility, refine the target population, and quickly test qualitative and quantitative changes in the microbiome after short-term travel to South or Southeast…
- Trial name
- ABROAD (NCT03043300)
- Testing
- Screening Criteria Review, Pre-Travel Questionnaire, Pre-Travel Stool Specimen Collection
- Where
- 2 sites in United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Emory University
Diarrhoea, Soil-transmitted Helminth Infection
Cluster Randomised Trial of Improved Sanitation in Rural Orissa, India
The study is a cluster-randomized, controlled trial conducted among 100 villages (including approximately 3500 households and 20,000 people) in Puri district, State of Orissa, India.
- Conditions
- Diarrhoea, Soil-transmitted Helminth Infection, Nutritional Status
- Trial name
- NCT01214785
- Testing
- Provision of household latrines
- Where
- India
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- London School of Hygiene and Tropical Medicine
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
Dysentery, Shigella
Safety and Efficacy Study of WRSS1, a Shigella Sonnei Vaccine Candidate
This study is an inpatient trial to determine the safety, immunogenicity and efficacy of the WRSS1 candidate vaccine in healthy Thai adult volunteers.
- Conditions
- Dysentery, Shigella, Diarrhea
- Trial name
- NCT01080716
- Testing
- Part 1/Arm 1 of Study: WRSS1 vaccine, Part 2/Arm 1 of Study: S. sonnei 53G, Part 2/Arm 2 of Study: S. sonnei 53G
- Where
- Thailand
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command