Dyspepsia Clinical Trial
Official title:
Helicobacter Pylori Eradication With Berberine Hydrochloride,Esomeprazole,Amoxicillin and Clarithromycin Versus Bismuth,Esomeprazole,Amoxicillin,and Clarithromycin: a Randomized,Open-label, Non-inferiority, Phase Ⅳ Trail
This study aims at evaluating efficacy and safety of berberine-containing quadruple therapy(berberine, esomeprazole, clarithromycin and amoxicillin) versus bismuth-containing quadruple therapy (bismuth,esomeprazole,clarithromycin and amoxicillin) in H. pylori eradication. It is hypothesized that berberine-containing quadruple therapy is non-inferior to bismuth-containing quadruple therapy. Patients with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 2 and 6 follow-up visits, a urea breath test(UBT) will be performed to confirm eradication.
The study will include three phases: screening, treatment and follow-up. Screening: this
phase will last a maximum of 28 days and subjects eligibility will be evaluated after
informed consent signature. Endoscopy and Urea Breath test will be performed in addition to
the baseline routine evaluations.
Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A
randomization visit will take place on Day 0 and an end-of-treatment visit will take place
between day 12 and 14.
Follow-up: includes two visits. approximately 14 days of treatment and 28 days after the end
of treatment. Eradication of H. Pylori will be confirmed through urea breath test(UBT).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06094062 -
Smartphone App-assisted PPI
|
N/A | |
| Completed |
NCT03941288 -
Efficacy and Safety of Cannabidiol for Gastroparesis and Functional Dyspepsia
|
Phase 2 | |
| Completed |
NCT04429802 -
The Effect of Prucalopride (Resolor®) on Gastric Motor Function and Gastric Sensitivity
|
N/A | |
| Not yet recruiting |
NCT06369753 -
Visible Abdominal Distension
|
N/A | |
| Withdrawn |
NCT02863822 -
Study to Evaluate Dietary Modification in Patients With Functional Dyspepsia.
|
N/A | |
| Recruiting |
NCT00978159 -
Esomeprazole or Famotidine in the Management of Aspirin Related Non-Ulcer Dyspepsia
|
Phase 4 | |
| Completed |
NCT00723502 -
Efficacy and Safety Study of Finafloxacin Used in Helicobacter Pylori Infected Patients
|
Phase 2 | |
| Terminated |
NCT00220844 -
Tricyclic Antidepressants (TCAs) on Gastric Emptying
|
N/A | |
| Completed |
NCT00217347 -
Evaluation of Efficiency of Esophageal Capsule Endoscopy in the Screening of Patients With Gastroesophageal Reflux Disease or Dyspepsia as Compared to Upper Endoscopy
|
N/A | |
| Completed |
NCT00148603 -
Montelukast in the Treatment of Duodenal Eosinophilia
|
N/A | |
| Completed |
NCT00164996 -
Ultrathin Versus Conventional Esophagogastroduodenoscopy in Unsedated Patient With or Without Local Pharyngeal Anaesthesia
|
Phase 3 | |
| Completed |
NCT00110968 -
Long-term Safety and Efficacy of Itopride Hydrochloride (HCl) in Patients Suffering From Functional Dyspepsia
|
Phase 3 | |
| Completed |
NCT00232102 -
Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia
|
Phase 3 | |
| Completed |
NCT00232037 -
Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia
|
Phase 3 | |
| Recruiting |
NCT05718960 -
Traditional Dietary Advice Versus Reassurance-alone in Postprandial Functional Dyspepsia
|
N/A | |
| Terminated |
NCT04247100 -
A Study of Randomized Sham-control Auricular TENS Unit Stimulation in Pediatric Functional Gastrointestinal Disorders
|
N/A | |
| Completed |
NCT05750641 -
The Efficacy of Removal of Animal Milk From the Diet in Functional Dyspepsia: A Cross-sectional Study
|
||
| Completed |
NCT04697641 -
Helicobacter Pylori Eradication in Functional Dyspepsia
|
N/A | |
| Completed |
NCT03252743 -
ICBT for Pain-predominant FGIDs in Children and Adolescents: an Implementation Study.
|
N/A | |
| Recruiting |
NCT04918329 -
Functional Digestive Disorders Observatory
|