Clinical trials: Diarrhea Infectious
Shigellosis, Bacillary Dysentery
Safety and Immunogenicity of Artificial Invaplex (Shigella Flexneri 2a InvaplexAR)
This study is an open-label, dose-escalating Phase 1 investigation of S. flexneri 2a InvaplexAR vaccine. A total of up to 40 subjects will receive one of four S. flexneri 2a InvaplexAR vaccine doses.
- Trial name
- NCT02445963
- Testing
- Shigella flexneri 2a InvaplexAR
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Campylobacter Infection
Safety Study of a Capsule-Conjugate Vaccine to Prevent Campylobacter-Caused Diarrhea
The purpose of this study is to assess the safety of increasing doses of a potential vaccine against Campylobacter with and without Alhydrogel®, an aluminum hydroxide adjuvant.
- Trial name
- CJCV1-01 (NCT02067676)
- Testing
- Capsule-Conjugate Campylobacter Vaccine (CJCV1), Alhydrogel®, aluminum hydroxide adjuvant (alum)
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Clostridium Difficile Infection
Microbiota or Placebo After Antimicrobial Therapy for Recurrent C. Difficile at Home (MATCH)
The purpose of this study is to determine whether Fecal Microbiota Therapy (FMT) is effective vs. placebo in the prevention of C. difficile infection recurrence.
- Trial name
- MATCH (NCT03005379)
- Testing
- Fecal Microbiota Therapy (FMT)
- Where
- United States
- Volunteers
- 153 people
- Sponsor
- VA Office of Research and Development
Clostridioides Difficile Infection
Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects
Study to evaluate the safety of ridinilazole in adolescent subjects and how ridinilazole is metabolized.
- Trial name
- Ri-CoDIFy 3 (NCT04802837)
- Testing
- Ridinilazole, Vancomycin
- Where
- 18 sites in United States
- Volunteers
- 2 people
- Sponsor
- Summit Therapeutics
Antibiotics Associated Colitis, Pulmonary Infection
Effect of Probiotic Lactobacilli (Lacidofil Cap®) for the Prevention of Antibiotic-Associated Diarrhea
Antibiotic-Associated Diarrhea (AAD) is a common complication of antibiotic use. The frequency of AAD can be high (26 - 60%) or moderate (13-29%) during hospital outbreaks and is relatively infrequent in outpatients.
- Trial name
- NCT01058356
- Where
- South Korea
- Volunteers
- 214 people
- Sponsor
- Pharmbio Korea Co., Ltd.
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
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.
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.
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, Clostridium Infections
Efficacy and Safety of BIO-K + CL1285 in Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients
The purpose of this study is to evaluate the efficacy and safety of Bio-K + CL1285 versus placebo in the prevention of antibiotic-associated diarrhea in hospitalized adult patients.
- Trial name
- NCT00328263
- Testing
- Lactobacillus acidophilus CL1285 and Lactobacillus casei
- Where
- 8 sites in Canada
- Volunteers
- 472 people
- Sponsor
- Bio-K Plus International Inc.
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
Pneumonia, Diarrhea
Azithromycin to Prevent Post-discharge Morbidity and Mortality in Kenyan Children
Children hospitalized with severe illness in sub-Saharan Africa are at high risk of morbidity and mortality following discharge from hospital.
- Conditions
- Pneumonia, Diarrhea, Malaria, Co-infection
- Trial name
- Toto Bora (NCT02414399)
- Testing
- Azithromycin
- Where
- Kenya
- Volunteers
- 1,400 people, healthy volunteers welcome
- Sponsor
- University of Washington
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
Diarrhoea, Clostridium Difficile
Proof-of-Concept, Calcium Aluminosilicate Anti-Diarrheal (CASAD) for Treatment of Clostridium Difficile Infection
Clostridium difficile (C. difficile) can cause symptoms ranging from mild diarrhea to life-threatening colitis. Illness from C. difficile most commonly affects patients in hospitals and long-term care facilities and typically…
- Trial name
- NCT01570634
- Testing
- Calcium Aluminosilicate Anti-Diarrheal (CASAD)
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Salient Pharmaceuticals Incorporated
Infectious Diarrhea
Film Array Gastrointestinal Panel Compared to Usual Care for ED Evaluation of Infectious Diarrhea
This research study will test a laboratory test called Film-Array Gastrointestinal (GI) Panel. This GI Panel is a test that can identify the bacteria or viruses that may cause diarrhea.
- Trial name
- NCT03809117
- Testing
- Biofire Film Array Gastrointestinal Panel
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- Andrew Meltzer
Covid19
Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection
This is a 2-part, 2-arm, Phase 2 , multicentre, randomized, double-blind, placebo-controlled study in adults with COVID-19 with gastrointestinal infection.
- Trial name
- RESERVOIR (NCT04858425)
- Testing
- Niclosamide
- Where
- 25 sites in United States, India and 1 more
- Volunteers
- 166 people
- Sponsor
- Entero Therapeutics
HIV Enteropathy, Diarrhea With HIV
Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea
This study is being conducted to evaluate the safety and tolerability of crofelemer 125 mg twice a day, taken orally, over 48 weeks of therapy in human immunodeficiency virus-positive (HIV+) subjects with diarrhea.
- Trial name
- NCT01374490
- Testing
- Crofelemer
- Where
- 21 sites in United States
- Volunteers
- 250 people
- Sponsor
- Bausch Health Americas, 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
Recurrent Clostridium Difficile Infection, Clostridium Difficile Infection
Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection
This study evaluates the efficacy of prophylaxis with oral vancomycin for preventing recurrent Clostridium difficile Infection (CDI) in patients who have experienced at least one CDI episode in the last 180 days and are receiving…
- Conditions
- Recurrent Clostridium Difficile Infection, Clostridium Difficile Infection, CDI, C.Difficile Diarrhea
- Trial name
- NCT03462459
- Testing
- Vancomycin
- Where
- 2 sites in United States
- Volunteers
- 79 people
- Sponsor
- University of Wisconsin, Madison
Clostridium Difficile Infection
Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection
The objectives of this study are: (1) to evaluate the safety and tolerability of VP 20621 dosed orally for up to 14 days in adults previously treated for CDI; (2) to characterize the frequency and duration of stool colonization…
- Trial name
- NCT01259726
- Testing
- VP20621
- Where
- 59 sites in United States, Belgium and 4 more
- Volunteers
- 173 people
- Sponsor
- Shire