Clinical trials: Gastroenteritis
- Condition Gastroenteritis
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
Ulcerative Colitis
New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis
The purpose of this study is to establish the efficacy and safety of a new tablet formulation and dosing regimen of balsalazide disodium dosed twice daily in achieving clinical improvement in subjects with mildly to moderately…
- Trial name
- NCT00269438
- Testing
- 5 ASA, enemas, suppositories, corticosteroids
- Where
- 66 sites in United States
- Volunteers
- 225 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Pharmacokinetics, Safety Issues
A Clinical Study With Adalimumab Biosimilar
The study aims to evaluate the pharmacokinetic profile, safety profile, and immunogenic potential of adalimumab of a new citrate-free formulation of adalimumab (Adalimumab Richmond) [Test Product] vs.
- Trial name
- NCT06291948
- Testing
- Humira® (adalimumab) AC Pen [Reference Product], Adalimumab Richmond [Test Product]
- Where
- Argentina
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Laboratorios Richmond S.A.C.I.F.
Healthy
Safety and Pharmacokinetic Study of PF-06651600 in Healthy Volunteers
This study is a first in human study of PF-06651600. PF-06651600 is being developed for treatment of inflammatory bowel disease. This study will test single and multiple doses of PF-06651600.
- Trial name
- NCT02309827
- Where
- Belgium
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Pfizer
MASH, PSC
A Microdose Trial Investigating Binding of [68Ga]Ga-DOTA-CYS-ATH001 in Healthy Subjects and Different Patient Groups.
The goal of this clinical trial is to use positron emission tomography (PET) to evaluate and compare the binding of the novel tracer [68Ga]Ga-DOTA-Cys-ATH001 in the liver and/or gastrointestinal tract between healthy volunteers…
- Conditions
- MASH, PSC, Fibrostenotic Crohn's Disease, Healthy Volunteers
- Trial name
- NCT06562361
- Testing
- [68Ga]Ga-DOTA-Cys-ATH001
- Where
- 3 sites in Sweden
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Antaros Medical
Norovirus Infections, Norwalk Gastroenteritis
Clinical Trial to Evaluate the Recombinant Norovirus Bivalent (GI. 1 / GII. 4) Vaccine (Hansenula Polymorpha)
Phase II clinical study will explore dose and safety, immunogenicity in 4 age groups, including 18-59 years old group, 6-17 years old group, 3-5 years old group, 6-35 months old group, with a total of 1716 subjects.
- Trial name
- NCT04941261
- Testing
- middle-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine, high-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine
- Where
- China
- Volunteers
- 1,716 people, healthy volunteers welcome
- Sponsor
- National Vaccine and Serum Institute, China
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
Ulcerative Colitis
A Study of Single and Multiple Ascending Doses of H021 in Healthy Participants
The primary purpose of this study is to evaluate the safety and tolerability of H021 tablets following oral administration of single and multiple ascending doses in healthy participants.
- Trial name
- NCT06627556
- Testing
- H021
- Where
- Australia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Jiangsu Carephar Pharmaceutical Co., Ltd.
Inflammatory Bowel Diseases, Irritable Bowel Syndrome
ALPCO Calprotectin ELISA - Measurement of Calprotectin Levels in Human Stool
The ALPCO Calprotectin ELISA is an in vitro diagnostic test intended to quantitatively measure concentrations of fecal calprotectin in human stool samples. Calprotectin is a protein biomarker of mucosal inflammation.
- Trial name
- NCT03082287
- Testing
- Fecal Calprotectin Level
- Where
- United States
- Volunteers
- 424 people, healthy volunteers welcome
- Sponsor
- American Laboratory Products Company
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
Gastritis
A Study of Compare the Pharmacokinetic, Pharmacodynamic and Safety/Tolerability Characteristics Following Multiple Oral Administration of AD-234, AD-2341, and AD-2342 in Healthy Adults
Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-234, AD-2341, AD-2342 in healthy subjects.
- Trial name
- NCT07717775
- Testing
- AD-234, AD-2341, AD-2342
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Addpharma Inc.
Ulcerative Colitis
PRObiotic VSL#3® for Maintenance of Clinical and Endoscopic REMission in Ulcerative Colitis
Ulcerative colitis (UC) is an inflammatory bowel disease (IBD) characterized by chronic inflammation limited to colonic mucosa. Its pathogenesis is not still clear, even if a multifactorial aetiology has been advocated.
- Trial name
- PROREM UC (NCT03415711)
- Testing
- VSL#3®, Mesalamine
- Where
- Italy
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- VSL Pharmaceuticals
Ulcerative Colitis, Crohn Disease
HMPL004-6599 Phase I Dose-escalating Study
To assess the safety and tolerability of single and multiple doses of HMPL004-6599 in healthy male volunteers
- Trial name
- NCT03597971
- Testing
- HMPL004-6599
- Where
- Australia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Nutrition Science Partners Limited
Crohn's Disease
Bologna IBD Markers
Individuate possible predictive factors of anti-TNFalfa-induced deep remission in Crohn's disease.
- Trial name
- NCT02580864
- Where
- Italy
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Inflammatory Bowel Disease (IBD)
A Phase 1 Study of PVT401 in Healthy Subjects
The goal of this clinical trial is to learn what happens to PVT401 when it enters the human body and how it affects the immune system.
- Trial name
- NCT07423000
- Testing
- PVT401, Normal Saline (0.9% NaCl)
- Where
- Australia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Parvus Therapeutics, Inc.
Inflammatory Bowel Disease (IBD)
Phase I Study of QLS1510 Tablets in Healthy Participants
This is a Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QLS1510 in Healthy participants
- Trial name
- NCT07760077
- Testing
- QLS1510 Tablets
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Shanghai Qilu Pharmaceutical Research and Development Center LTD
Gastroenteritis, Rotavirus
Safety,Tolerability and Immunogenicity of Vaccination With Rotateq in Healthy Infants in India (V260-021)
To observe the safety, tolerability and immunogenicity of the administration of 3 doses of rotateq in healthy Indian infants between 6 weeks through exactly 12 weeks of age at entry.
- Trial name
- NCT00496054
- Testing
- Rotavirus Vaccine, Live, Oral, Pentavalent
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Eosinophilic Esophagitis
Comparing the Availability of AQ280 in the Body After Single Oral Doses of a Capsule Formulation Versus a Tablet for Oral Suspension Formulation
This is a Phase 1, investigator- and participant-blinded, placebo-controlled, randomized, crossover study to compare bioavailability of AQ280 following single oral doses of a capsule formulation versus a tablet for oral…
- Trial name
- NCT07093008
- Testing
- AQ280 Capsule, AQ280 Tablet for Oral Suspension
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- AQILION AB
Reflux Oesophagitis
Effect of 5, 10 or 25 mg of YF476 Daily for 14 Days on Stomach Acidity in Healthy Volunteers
The objective of the study was to assess whether the tolerance to the effect of YF476 on gastric pH observed with repeated doses in a previous study in healthy volunteers can be avoided by using smaller doses of YF476.
- Trial name
- NCT01597674
- Testing
- YF476
- Where
- United Kingdom
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Trio Medicines Ltd.
Rotavirus Gastroenteritis
Efficacy, Safety and Immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in Neonates
This phase III trial aims to assess the efficacy, safety and immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in neonates, lot-to-lot consistency, and antigen interference with co-administered EPI vaccines
- Trial name
- NCT04185545
- Testing
- Rotavirus RV3 Vaccine (Bio Farma)
- Where
- 21 sites in Indonesia
- Volunteers
- 1,400 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Shigellosis
Study to Expand Safety and Immunogenicity Data With Shigella Bioconjugate Vaccine (Shigella4V2) in 9-month-old Infants.
In this study, the second-generation tetravalent bioconjugate candidate vaccine Shigella4V2 will be tested to confirm data on its safety and immunogenicity in infants and to identify the best dose of Shigella4V2 in 9-month-old…
- Trial name
- S4V02 (NCT06523231)
- Testing
- Shigella4V2, MenACWY
- Where
- Kenya
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- LimmaTech Biologics AG