Treatment of Helicobacter Pylori Infection in Children with Nitazoxanide
Official title: Study of Novel Triple Nitazoxanide (NTZ) Based New Therapeutic Regimens for Helicobacter Pylori in Children
Run by Tanta University · NCT04415983 · Data updated 2026-11-12
This study is testing a new combination treatment for Helicobacter pylori infections in children to see if it works better than current options.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | Any age to 18 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta) |
| Status | Recruiting |
| Started | June 1, 2020 |
| Main results expected | October 1, 2030 |
| Study ends | December 1, 2030 |
| Registry record updated | June 4, 2020 |
| Trial ID | NCT04415983 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children who have tested positive for Helicobacter pylori infection.
✕Probably not a fit
Patients who have previously undergone treatment for Helicobacter pylori will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of a novel triple therapy regimen using Nitazoxanide (NTZ) combined with Clarithromycin and Metronidazole, along with a proton pump inhibitor, to treat Helicobacter pylori infections in children. The approach aims to provide a new therapeutic option for this common infection, which can lead to significant gastrointestinal issues if left untreated. The study is designed as a Phase 3 interventional trial, focusing on children who test positive for Helicobacter pylori.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and safer option for eradicating Helicobacter pylori in children.
How similar studies have gone: Other studies have explored treatments for Helicobacter pylori, but the specific use of Nitazoxanide in this context is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Positive helicobacter infection. Exclusion Criteria: * Previous treatment for H. Pylori.
Where it's running
-
Sherief Abd-Elsalam
Tanta, Egypt Recruiting
Study contacts
- Principal investigator: Rasha Gamal, Ass. Prof. — Pediatrics department - Tanta University
- Study coordinator: Sherief Abd-Elsalam, ass. prof.
- Email: sheriefabdelsalam@yahoo.com
- Phone: 00201147773440
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Fecal transplant to help eradicate stubborn Helicobacter pylori infection
This study tests whether giving a fecal microbiota transplant can help people with Helicobacter pylori infection that has not responded to standard treatments.
-
Fecal-guided simplified vonoprazan plus clarithromycin first-line therapy for H. pylori
We are testing whether a two-drug regimen of vonoprazan plus clarithromycin clears H. pylori in adults whose fecal PCR shows no clarithromycin resistance mutations.
-
Bismuth-amoxicillin-vonoprazan triple therapy versus bismuth-based quadruple therapy for H. pylori infection
This will test whether a 14-day bismuth-amoxicillin-vonoprazan triple therapy works better and is as safe as a 14-day bismuth-based quadruple therapy for adults with H. pylori infection.
-
P-CABs plus bismuth quadruple treatment for Helicobacter pylori infection
This study tests whether using potassium-competitive acid blockers (P-CABs) in bismuth-containing quadruple therapy works better and is safe for adults with H. pylori infection.
-
Bismuth versus no bismuth for treating H. pylori-related stomach and duodenal ulcers in children
This project will try adding bismuth to standard antibiotic and PPI treatment to see if it helps clear H. pylori and heal ulcers in children.
-
Tegoprazan 50 mg twice daily plus amoxicillin versus vonoprazan 20 mg twice daily plus amoxicillin for H. pylori eradication
This trial tests whether a 14-day tegoprazan plus amoxicillin regimen works as well as a vonoprazan plus amoxicillin regimen to cure Helicobacter pylori infection in adults.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.