Clinical trials: Infectious Diarrhea
Diarrhoea
A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants
The aim of the current clinical study was to evaluate, for the first time in humans (FTIH), the safety and immunogenicity of the altSonflex1-2-3 candidate vaccine against S. sonnei and S. flexneri serotypes 1b, 2a, and 3a.
- Trial name
- NCT05073003
- Testing
- AltSonflex1-2-3 High Dose, AltSonflex1-2-3 Medium Dose, AltSonflex1-2-3 Low Dose
- Where
- 2 sites in Belgium, Kenya
- Volunteers
- 551 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Shigella
Shigella CVD 30000: Study of Responses to Vaccination With Shigella Vaccine
The purpose of this study is to determine whether SF2a-TT15 (a monovalent synthetic carbohydrate-based conjugate Shigella vaccine) is safe and effective in the prevention of Shigella infection.
- Trial name
- NCT04078022
- Testing
- SF2a-TT15 Shigella Vaccine, S. flexneri 2a strain 2457T Challenge Agent
- Where
- United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
Clostridium Difficile Infection, Clostridium Difficile Diarrhea
Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity
This Phase I, randomized, placebo-controlled, double-blinded, dose ranging study to assess the safety, tolerability, and immunogenicity of 2 dose levels of C. difficile vaccine.
- Trial name
- NCT00772954
- Testing
- Vaccine diluent buffer, Clostridium difficile toxoid vaccine (50 μg), Clostridium difficile toxoid vaccine (100 μg)
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Sanofi
HIV Associated Diarrhea
Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea
This is a randomized, double-blind, parallel-group, placebo-controlled, multi-center study. This study will compare an investigational new drug (crofelemer) to placebo for the control of HIV-associated diarrhea.
- Trial name
- ADVENT (NCT00547898)
- Testing
- Crofelemer 125 mg, Crofelemer 250 mg, Crofelemer 500 mg
- Where
- 82 sites in United States, Puerto Rico
- Volunteers
- 374 people
- Sponsor
- Bausch Health Americas, Inc.
Clostridium Enterocolitis, Pseudomembranous Colitis
Compassionate Use of Nitazoxanide for the Treatment of Clostridium Difficile Infection
The purpose of this study is for compassionate use of nitazoxanide in the treatment of diarrheal disease due to Clostridium difficile infection when the patient has failed previous treatment with metronidazole or vancomycin.
- Trial name
- NCT00304356
- Testing
- Nitazoxanide
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Daniel M. Musher MD
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
Anaerobic Infection, Infectious Enterocolitis
Anaemetro I.V. Infusion 500mg Drug Use Investigation
Secondary Data Collection Study; safety and effectiveness of Anaemetro under Japanese medical practice
- Conditions
- Anaerobic Infection, Infectious Enterocolitis, Amebic Dysentery
- Trial name
- NCT03491228
- Volunteers
- 107 people
- Sponsor
- Pfizer
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, Diarrhea
Efficacy of Rifaximin in Preventing Campylobacteriosis
This study is a randomized, double-blinded, placebo-controlled, in-patient trial evaluating the prophylactic efficacy of rifaximin against campylobacteriosis following challenge with C. jejuni.
- Conditions
- Dysentery, Diarrhea, Enteric Campylobacteriosis
- Trial name
- NCT02280044
- Testing
- Rifaximin intervention
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Healthy
Dose-Finding Study of Lyophilized Shigella Sonnei 53G Challenge Strain
Development of an S. sonnei human challenge model using a newly manufactured lyophilized lot of S. sonnei strain 53G (Lot 1794) that can be used in the future as a challenge strain for all S. sonnei vaccine candidates.
- Trial name
- NCT02816346
- Testing
- Shigella sonnei 53G
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- PATH
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
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.
Diarrhea, Respiratory Infection
Micronutrient Sprinkles in a Daycare Center
Diarrheal diseases are a major cause of morbidity and mortality globally in children less than 5 years of age. Prolonged diarrhea, recurrent infections and growth failure in developing countries are usually a consequence of…
- Trial name
- NCT00967551
- Testing
- Micronutrient Sprinkles with zinc, Micronutrient sprinkles without zinc
- Where
- Brazil
- Volunteers
- 143 people, healthy volunteers welcome
- Sponsor
- Emory University
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
Shigellosis
Safety, Immunogenicity and Efficacy of Shigella Conjugate Vaccines in 1-4 Year Olds in Israel
Shigellosis remains a serious and frequent disease throughout the world. Development of vaccines has been difficult because shigellae are habitants of and pathogens for humans only and there is no consensus about the mechanism(s)…
- Trial name
- NCT00368316
- Testing
- Shigella conjugate vaccines
- Where
- 2 sites in Israel
- Volunteers
- 2,799 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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
Diarrhea
Shigella WRSS1 Vaccine Trial in Bangladesh
This is a research study of an experimental (investigational) live attenuated Shigella sonnei vaccine (WRSS1) to find a dose of the vaccine that is safe, tolerable, and develops an immune response.
- Trial name
- NCT02934178
- Testing
- Shigella sonnei Strain WRSS1 Vaccine
- Where
- Bangladesh
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- PATH
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
Dysentery, Bacillary
A Study to Evaluate the Efficacy, Safety and Immunogenicity of a Vaccine Designed to Protect Against Infection With Shigella Sonnei in Healthy Adults
The purpose of this study is to evaluate the efficacy, safety and immunogenicity of the GSK3536852A vaccine, which was designed to protect against shigellosis caused by Shigella sonnei (S.
- Trial name
- NCT03527173
- Testing
- S.sonnei vaccine, S. sonnei 53G challenge strain
- Where
- United States
- Volunteers
- 71 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.