Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to learn if including bismuth in the treatment helps heal stomach and duodenal ulcers caused by Helicobacter pylori (H. pylori) in children.
The main questions it aims to answer are:
Researchers will compare two treatment groups to see which works better. Participants will:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bismuth quadruple therapy | Experimental | Patients in this arm will receive PPI, Amoxicillin, Metronidazole, and Bismuth for 14 days, with doses adjusted according to weight and age. |
|
| Triple therapy with PPI + Amoxicillin + Metronidazole | Experimental | Patients in this arm will receive PPI, Amoxicillin, Metronidazole for 14 days, with doses adjusted according to weight and age. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bismuth quadruple therapy | Drug | A 14-day regimen including proton pump inhibitor (PPI; esomeprazole [Nexium MUPS]), bismuth subcitrate (or bismuth subsalicylate), amoxicillin, and metronidazole. All drug doses are adjusted according to the participant's age and weight. |
| Measure | Description | Time Frame |
|---|---|---|
| Eradication rate of Helicobacter pylori infection between the two treatment regimens | The efficacy of the two regimens will be evaluated by comparing H. pylori eradication rates. Clinical examination and a urea breath test or stool antigen test will be performed after completion of therapy to confirm eradication. Patients will receive a 14-day treatment regimen, followed by an additional 2-4 weeks of proton pump inhibitor (PPI) therapy to promote healing of gastric or duodenal lesions. | Two weeks after discontinuation of acid suppression therapy following completion of the eradication regimen. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trang Thuy Mai, MD | Contact | +84 838 857 890 | maithuytrang2000@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Can Tho Children's Hospital | Recruiting | Can Tho | 900000 | Vietnam |
Not provided
Not provided
Not provided
Not provided
Not provided
| Triple therapy with PPI + Amoxicillin + Metronidazole | Drug | A 14-day regimen including proton pump inhibitor (PPI; esomeprazole [Nexium MUPS]), amoxicillin, and metronidazole. All drug doses are adjusted according to the participant's age and weight. |
|
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| ID | Term |
|---|---|
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided