Clinical trials: Diarrhoea
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
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
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
Diarrhoea
Safety and Efficacy of IQP-MM-101 in Reducing Symptoms of Diarrhoea
Diosmectite in IQP-MM-101 has been used for diarrhoea control. Backed by data from several studies demonstrating their efficacy, the investigators are conducting this study to look into the efficacy and safety of IQP-MM-101 in…
- Trial name
- NCT01969214
- Testing
- IQP-MM-101
- Where
- Germany
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- InQpharm Group
ETEC Diarrhea
Pre-Study of Wild Type Enterotoxigenic E. Coli (ETEC) Strain for Verification of a Planned Challenge Dose
This was an open-label, single-site pre-study designed to evaluate the safety, tolerability, and infectivity of wild-type Enterotoxigenic Escherichia coli (ETEC) strain E24377A in healthy adults.
- Trial name
- NCT06290089
- Testing
- Enterotoxigenic E. coli (ETEC) strain
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Scandinavian Biopharma AB
Autism Spectrum Disorder, Gastrointestinal Symptoms
Combination Probiotic: BB-12 With LGG (Different Doses) in Treating Children With Autism Spectrum Disorder
This protocol is a blinded randomized controlled study of the effects of BB-12 with LGG at different doses in 70 healthy children with autism spectrum disorders at lower and higher doses over an 56-day period and a 28- day…
- Trial name
- NCT03514784
- Testing
- BB-12 with LGG (Higher Dose), BB-12 with LGG (Lower Dose)
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston
Escherichia Coli Infection
Safety Study of Chimeric Vaccine to Prevent ETEC Diarrhea
The purpose of the study is to determine if immunization with a chimeric E. coli protein, dsc14CfaE-sCT2/LTB5, is safe and immunogenic when administered by vaccination under the skin.
- Trial name
- NCT01644565
- Testing
- Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5, Recombinant fimbrial adhesin dscCfaE, Modified E. coli heat labile enterotoxin LTR192G
- Where
- United States
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Diarrhea
Safety and Immunogenicity Study of Traveler's Diarrhea Vaccine Patch
The purpose of this study is to evaluate and compare the safety and immune responses following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E.
- Trial name
- NCT01067781
- Testing
- Heat-Labile Enterotoxin of E. coli (LT)
- Where
- 5 sites in United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Intercell USA, Inc.
Diarrhea, Diarrhea Rotavirus
Phase III Study of Liquid Formulation of ROTAVIN
This study is conducted to demonstrate non-inferiority in the immunogenicity of the liquid formulation of ROTAVIN in comparison to currently licensed frozen formulation of the vaccine (ROTAVIN-M1), 28 days after the second…
- Trial name
- NCT03703336
- Testing
- ROTAVIN (liquid formulation), ROTAVIN-M1 (frozen formulation)
- Where
- 2 sites in Vietnam
- Volunteers
- 825 people, healthy volunteers welcome
- Sponsor
- Center for Research and Production of Vaccines and Biologicals, Vietnam
Diarrhea, Gastroenteritis
An Alternate Dosing Schedule for Pentavalent Rotavirus Vaccine (RotaTeq)
This is a pilot study to assess the safety and immunogenicity of pentavalent rotavirus vaccine (RV5) when administered according to an alternate dosing schedule (2-5 weeks, 2 months and 4 months).
- Trial name
- NCT01960725
- Testing
- RV5 (Pentavalent Rotavirus Vaccine)
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Dennis Clements
Antibiotic-associated Diarrhea
Mechanisms of Preventing Antibiotic-Associated Diarrhea and the Role for Probiotics
The focus of the study is to better understand the mechanisms causing antibiotic-associated diarrhea (AAD) and how probiotics may prevent some of the iatrogenic effects of antibiotic medications.
- Trial name
- YOBIOTIC (NCT03755765)
- Testing
- Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet, BB-12, Control
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Georgetown University
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.
Prevention of Travelers' Diarrhea
LT Vaccine Patch Self-Administration Study
To evaluate the immune responses achieved following self-administered heat-labile enterotoxin of E. coli (LT) vaccination by transcutaneous immunization compared to the immune responses achieved by clinician-administered…
- Trial name
- NCT00565461
- Testing
- heat-labile enterotoxin of E. coli (LT)
- Where
- 3 sites in United States
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Intercell USA, Inc.
Healthy
Safety of Lactobacillus Reuteri in Healthy Children Aged 2-24 Months
Phase I double blinded randomized trial of the safety and tolerability of Lactobacillus reuteri DSM 17938 given for five successive days in healthy children.
- Trial name
- PRIDEC Peru (NCT02460575)
- Testing
- Lactobacillus reuteri 17938
- Where
- Peru
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Tulane University School of Medicine
Obesity
Effects of Carbohydrate in Diet and Supplements on the Gastrointestinal Tolerability of LIK066
The purpose of this study was to determine if LIK066 taken with a meal containing low carbohydrate is associated with less diarrhea compared to a high carbohydrate meal and to assess the potential effects of supplements such as…
- Trial name
- NCT03198767
- Testing
- LIK066, Carbohydrate 50%, Carbohydrate 25%
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Recurrent C. Difficile Associated Diarrhea
Fresh, Frozen or Lyophilized Fecal Microbiota Transplantation for Multiple Recurrent C. Difficile Associated Diarrhea
The objective of the study is to investigate the efficacy of fresh, frozen or lyophilized fecal microbiota transplantation (FMT) via colonoscopy in patients with recurrent C. difficile associated diarrhea (RCDAD).
- Trial name
- NCT02318992
- Testing
- Fecal Microbiota
- Where
- United States
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston
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
Live Attenuated ETEC Vaccine ACE527 With and Without dmLT Adjuvant in Adults
This is a research study about an experimental (investigational) oral ETEC vaccine (ACE527). ACE527 is a live attenuated vaccine that is being made to prevent disease from enterotoxigenic Escherichia coli (ETEC), which causes…
- Trial name
- NCT01739231
- Testing
- ACE527, dmLT, H10407 challenge strain
- Where
- United States
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- PATH
Healty Volunteers, Preventable Disease, Vaccine
A Phase 2 Bridging Study to Assess the New Formulation of ETVAX
This is a phase 2,prospective double-blind, randomized, parallel-group study with the aim to demonstrate non-inferiority, in terms of immunogenicity, between the wet formulation and a newly developed partially dried formulation…
- Trial name
- NCT05178134
- Testing
- Etvax
- Where
- Sweden
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- Scandinavian Biopharma AB
Prevention of Travelers' Diarrhea
Traveler's Diarrhea (TD) Automated Process
To evaluate and compare the immune responses and safety following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or placebo patches.
- Trial name
- NCT00751777
- Testing
- heat-labile enterotoxin of E. coli (LT)
- Where
- 3 sites in United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Intercell USA, Inc.