Clinical trials: Diarrhea Infectious
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
Clostridium Difficile Infection (CDI)
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes.
- Trial name
- NCT03244644
- Testing
- RBX2660, Open label RBX2660 (only for confirmed CDI recurrence)
- Where
- 66 sites in United States, Canada
- Volunteers
- 320 people
- Sponsor
- Rebiotix Inc.
Clostridium Difficile Infection
Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-005)
606 participants with Clostridium Difficile Associated Diarrhea (CDAD) participated in this study and received either oral vancomycin or CB-183,315 (surotomycin) in a blinded fashion.
- Trial name
- NCT01597505
- Testing
- Surotomycin, Vancomycin
- Volunteers
- 606 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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
Infectious Diarrhoea
Efficacy and Safety of CB-01-11 200mg Tablets in Infectious Diarrhoea
To assess the safety and the preliminary efficacy data on the three doses of the new Cosmo Technologies oral rifamycin SV colon-release 200 mg tablets manufactured according to MMX technology (CB-01-11) in the treatment of…
- Trial name
- NCT03447821
- Testing
- 400 mg Rifamycin SV dosage, 800 mg Rifamycin SV dosage, 1200 mg Rifamycin SV dosage
- Volunteers
- 40 people
- Sponsor
- Cosmo Technologies Ltd
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
Clostridium Difficile Infection
ACX-362E [Ibezapolstat] for Oral Treatment of Clostridioides Difficile Infection
Segments 2A and 2B of this trial evaluate the safety, efficacy, pharmacokinetics, fecal concentrations, and fecal microbiome effects of ACX-362E [ibezapolstat] in patients with C. difficile infection (CDI).
- Trial name
- NCT04247542
- Testing
- Ibezapolstat, Vancomycin
- Where
- 29 sites in United States
- Volunteers
- 53 people
- Sponsor
- Acurx Pharmaceuticals Inc.
Clostridium Difficile Infection
Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea
This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).
- Trial name
- NCT01983683
- Testing
- Cadazolid, Vancomycin
- Volunteers
- 631 people
- Sponsor
- Actelion
Antibiotic-Associated Diarrhea, Clostridium Difficile-Associated Diarrhea
Efficacy and Safety Study in the Prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridium Difficile-Associated Diarrhea (CDAD) in Hospitalized Adult Patients Exposed to Nosocomial Infection
The purpose of this study is to evaluate the efficacy and safety of Bio-K+ CL-1285 in the prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridum difficile-Associated Diarrhea (CDAD) in hospitalized patients exposed to…
- Trial name
- NCT00958308
- Testing
- BIO-K+ CL-1285®
- Volunteers
- 255 people, healthy volunteers welcome
- Sponsor
- Bio-K Plus International Inc.
Clostridium Difficile Infection, Infection
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)
This is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round of…
- Conditions
- Clostridium Difficile Infection, Infection, Communicable Diseases
- Trial name
- CD3-OLS (NCT03931941)
- Testing
- RBX2660
- Where
- 51 sites in United States, Canada
- Volunteers
- 793 people
- Sponsor
- Rebiotix Inc.
Clostridium Difficile Infection Recurrence
A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection
This trial will be initiated to explore whether RBX2660 (REBYOTA®) could be suitable for administration by the practice of colonoscopy.
- Trial name
- CDI-SCOPE (NCT05831189)
- Testing
- RBX2660
- Where
- 12 sites in United States
- Volunteers
- 41 people
- Sponsor
- Ferring Pharmaceuticals
Dysentery, Bacillary
A Study to Evaluate Safety and Immunogenicity of 1 Booster Dose of 1790GAHB Vaccine in Healthy Adults Primed With 3 Doses of 1790GAHB Vaccine in Study H03_01TP Compared to 1 Vaccination of 1790GAHB in Either Subjects Who Received Placebo in the Same Study or naïve Subjects Not Part of H03_01TP Study
GVGH Shigella Sonnei 1970GAHB is a vaccine aimed at preventing the disease caused by Shigella sonnei. A post-hoc analysis of subjects who participated in the parent study showed significantly different responses in subjects with…
- Trial name
- NCT03089879
- Testing
- GVGH Shigella sonnei 1790GAHB vaccine
- Where
- France
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Traveler's Diarrhea
Rifamycin SV-MMX® Tablets Versus Ciprofloxacin Capsules in Acute Traveller's Diarrhoea
The purpose of this study is to prove the non-inferiority of Rifamycin SV-MMX® versus Ciprofloxacin for the treatment of adults with traveller's diarrhoea.
- Trial name
- ERASE (NCT01208922)
- Testing
- Rifamycin SV-MMX®, Ciprofloxacin
- Where
- 19 sites in Ecuador, Guatemala and 1 more
- Volunteers
- 835 people
- Sponsor
- Dr. Falk Pharma GmbH
Intestinal Amebiasis
Ameparomo Capsules 250 mg Drug Use Investigation
This Study is intended to evaluate the safety and effectiveness of Ameparomo Capsules 250 mg under actual medical practice.
- Trial name
- NCT02680665
- Volunteers
- 120 people
- Sponsor
- Pfizer
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.
Recurrent Clostridium Difficile Infection
Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea
This study will assess the safety of a new biologic drug, RBX2660 (microbiota suspension) as a treatment for recurrent Clostridium difficile-associated diarrhea (CDAD), which is the primary symptom of recurrent Clostridium…
- Trial name
- PUNCH CD (NCT01925417)
- Testing
- RBX2660 (microbiota suspension)
- Where
- 13 sites in United States
- Volunteers
- 34 people
- Sponsor
- Rebiotix Inc.
Clostridium Difficile-associated Diarrhea (CDAD)
A Study to Investigate the Safety and Efficacy of Fidaxomicin (Oral Suspension or Tablets) and Vancomycin (Oral Liquid or Capsules) in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
The purpose of this study was to investigate the clinical response to fidaxomicin oral suspension or tablets and vancomycin oral liquid or capsules in pediatric participants with Clostridium difficile-associated diarrhea (CDAD).
- Trial name
- SUNSHINE (NCT02218372)
- Testing
- Fidaxomicin oral suspension, Fidaxomicin tablets, Vancomycin oral liquid
- Where
- 44 sites in United States, Belgium and 8 more
- Volunteers
- 148 people
- Sponsor
- Astellas Pharma Europe B.V.
Clostridium Difficile Infection
A Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-006)
A total of 608 participants with Clostridium Difficile Associated Diarrhea (CDAD) will participate in this study; participants will receive either oral vancomycin or CB-183,315 in a blinded fashion.
- Trial name
- NCT01598311
- Testing
- CB-183,315, Vancomycin
- Volunteers
- 608 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Clostridium Difficile Infection
Comparison of Cadazolid Versus Vancomycin in Children With Clostridium Difficile-associated Diarrhea (CDAD)
Cadazolid has demonstrated activity against a bacteria named Clostridium difficile in animal studies. The results of a first study conducted in adult patients have suggested efficacy of the new antibiotic, cadazolid, in the…
- Trial name
- NCT03105479
- Testing
- Cadazolid, Vancomycin capsule, Vancomycin solution
- Where
- 20 sites in United States, Belgium and 7 more
- Volunteers
- 1 people
- Sponsor
- Actelion