Clinical trials: Diarrhea Infectious
Shiga Toxin Producing Bacterial Infection
Study of Chimeric Monoclonal Antibodies to Shiga Toxins 1 and 2
This study is designed to evaluate the safety and efficacy of cαStx1 and cαStx2 administered concomitantly in children presenting early signs of Shiga Toxin-Producing Bacterial (STPB) Infection.
- Trial name
- NCT01252199
- Testing
- cαStx1/cαStx2
- Where
- 11 sites in Argentina, Chile and 1 more
- Volunteers
- 45 people
- Sponsor
- Thallion Pharmaceuticals
Shigella, Diarrhea
First in Human Dose Escalation Study Evaluating the Safety and Immunogenicity of IVT's Shigella-04 Vaccine in Healthy Young Adults
Phase 1 trial to evaluate the Safety and Immunogenicity of Inventprise's (IVT) Shigella-04 in Healthy Young Adults
- Trial name
- NCT07205926
- Testing
- IVT Shigella-04
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Inventprise Inc.
Clostridium Difficile Infection, Diarrhea
Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in Adults
This study will further evaluate the ACAM-CDIFF™ vaccine in a population of middle-aged to elderly individuals at risk of exposure to Clostridium difficile because of impending hospitalization or residence in a care facility.
- Trial name
- NCT01230957
- Testing
- Clostridium difficile toxoids A and B (Low-dose with adjuvant), Clostridium difficile toxoids A and B (Low-dose without adjuvant), Clostridium difficile toxoids A and B (high-dose with adjuvant)
- Where
- 30 sites in United States
- Volunteers
- 650 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Diarrhea, HIV Infections
A Multicenter Placebo-Controlled Dose Titration Study to Evaluate the Efficacy and Safety of Sandostatin (SMS 201-995) in the Treatment of Patients With Acquired Immunodeficiency Related Diarrhea
To determine the efficacy and safety of Sandostatin (octreotide) compared to placebo in controlling diarrhea which is a manifestation or complication of documented HIV infection and which is refractory (does not respond) to all…
- Trial name
- NCT00002252
- Testing
- Octreotide
- Where
- 23 sites in United States
- Sponsor
- Sandoz
Clostridium Difficile Infection
Safety and Clinical Effectiveness of Oral Probiotic MIYA-BM to Prevent Recurrent Clostridium Difficile Infections
Patients with confirmed C. difficile infection (CDI) who meet eligibility requirements will be invited to participate. All study patients must receive treatment for CDI with metronidazole or vancomycin.
- Trial name
- NCT01077245
- Testing
- MIYA-BM Fine Granules (CBM588)
- Sponsor
- Osel, Inc.
Clostridium Difficile Infection
Study to Assess Safety, Tolerability and Efficacy of Incremental Doses of MGB-BP-3 in Patients With CDAD
The objective of this Phase IIa study is to assess the safety, tolerability, and efficacy of incremental doses of MGB-BP-3 in patients with Clostridium difficile-associated diarrhea (CDAD).
- Trial name
- NCT03824795
- Testing
- MGB-BP-3
- Where
- 9 sites in United States, Canada
- Volunteers
- 34 people
- Sponsor
- MGB Biopharma Limited
Shigellosis, Bacillary Dysentery
SF2a-TT15 Conjugate Vaccine in Healthy Adult Volunteers
This is a first-in-human, single-center, single-blinded, observer-masked randomized, dose escalation (two doses), placebo-controlled study in healthy volunteers.
- Trial name
- NCT02797236
- Testing
- SF2a-TT15 vaccine, SF2a-TT15 vaccine + adjuvant
- Where
- Israel
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Dysentery, Dysentery, Shigella
Clinical Trial of the S. Flexneri-S. Sonnei Bivalent Conjugate Vaccine
The goal of this clinical trial is to evaluate the protective efficacy of S. Flexneri-S. Sonnei bivalent conjugate vaccine against diarrhea caused by Shigella infection in infants and children aged 6 months to 5 years.
- Trial name
- NCT06838195
- Testing
- S. Flexneri-S. Sonnei bivalent conjugate vaccine
- Where
- Bangladesh
- Volunteers
- 8,000 people, healthy volunteers welcome
- Sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Shigellosis
A Human Challenge Study to Assess Protection of a Shigella Tetravalent Bioconjugate Vaccine
In this challenge study, the bioconjugate candidate vaccine Shigella4V2 will be tested for its ability to induce an immune response that protects healthy adult volunteers from infection with a wild-type Shigella sonnei strain…
- Trial name
- S4V03 (NCT06615375)
- Testing
- Shigella4V2
- Where
- 3 sites in United States
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- LimmaTech Biologics AG
Clostridium Difficile Infection
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
This study will evaluate efficacy and safety information about RBX2660 for the treatment of recurrent Clostridium difficile infection (CDI), and will compare the efficacy of one treatment with RBX2660 versus antibiotic-treated…
- Trial name
- NCT02589847
- Testing
- RBX2660, Standard of Care Antibiotics
- Where
- 30 sites in United States, Canada
- Volunteers
- 272 people
- Sponsor
- Rebiotix Inc.
Healthy Term Infants
The Combiotic-Study
The primary objective of this study is to demonstrate that a synbiotic formula, fed for the duration of the first year of life (infant and follow-on formula) reduces the incidence rate of episodes of infectious diarrhea in…
- Trial name
- GOLFIII (NCT02221687)
- Testing
- Synbiotic formula, Control formula
- Where
- 25 sites in France
- Volunteers
- 540 people, healthy volunteers welcome
- Sponsor
- HiPP GmbH & Co. Vertrieb KG
Diarrhea, Gastroenteritis
Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea
The goal of this clinical trial is to learn how rifaximin 200 mg is processed in the body (pharmacokinetics) in children 6 to 11 years old with acute diarrhea that may be caused by bacteria.
- Conditions
- Diarrhea, Gastroenteritis, Bacterial Infection, Acute Diarrhea
- Trial name
- NCT07285785
- Testing
- Rifaximin 200 mg Tablet, Oral Rehydration Therapy (ORT)
- Where
- 10 sites in United States
- Volunteers
- 54 people
- Sponsor
- Bausch Health Americas, Inc.
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.
Diarrhea, HIV Infections
A Multicenter Placebo-Controlled Double Blind Study to Evaluate the Efficacy and Safety of Sandostatin ( SMS 201-995 ) in Patients With Acquired Immunodeficiency Related Diarrhea Who Were Either "Responders" or "Non-Responders" in a Prior Placebo-Controlled Double-Blind Sandostatin Study.
The primary objective of this study is to determine the relapse rate in patients with AIDS-related diarrhea who were found to be "Responders" in a previous placebo-controlled, double-blind study of Sandostatin (Study #D203 - FDA…
- Trial name
- NCT00002253
- Testing
- Octreotide
- Where
- 22 sites in United States
- Sponsor
- Sandoz
Healthy Volunteers
ShigETEC Vaccine Study in Bangladesh
The goal of this clinical trial is to test ShigETEC vaccine, a combination vaccine against Shigella and ETEC diarrhoea in Bangladeshi adults (aged 18-45 years) and paediatric participants of three different age groups (aged 2-5…
- Trial name
- NCT05987488
- Testing
- ShigETEC live, attenuated, oral vaccine
- Where
- Bangladesh
- Volunteers
- 196 people, healthy volunteers welcome
- Sponsor
- Eveliqure Biotechnologies GmbH
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
Shigellosis
Safety and Reactogenicity of Bioconjugate Vaccine to Prevent Shigella
Healthy volunteers will receive a 2-dose vaccination with Shigella dysenteriae candidate vaccine spaced 8 weeks apart. The objective is to demonstrate the safety and reactogenicity of the Shigella dysenteriae bioconjugate vaccine…
- Trial name
- NCT01069471
- Testing
- Shigella vaccine
- Where
- Switzerland
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- GlycoVaxyn AG
Diarrhea, Acute Respiratory Infection
Oral Supplement for Pregnant and Lactating Mothers
To assess protection against early life infections through supplementation of mothers during pregnancy to the newborns' growth, morbidity, immune status intra and extra-uterine.
- Trial name
- NCT01073033
- Testing
- milk supplement 1, milk supplement 2
- Where
- Philippines
- Volunteers
- 234 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)