Antibiotyping and Prevalence of Virulent Genotypes Among Helicobacter Pylori and Their Impact on Response to Therapy
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ClinicalTrials.gov Identifier: NCT05444439 |
Recruitment Status :
Not yet recruiting
First Posted : July 6, 2022
Last Update Posted : July 6, 2022
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Tracking Information | |||||
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First Submitted Date ICMJE | June 14, 2022 | ||||
First Posted Date ICMJE | July 6, 2022 | ||||
Last Update Posted Date | July 6, 2022 | ||||
Estimated Study Start Date ICMJE | September 2022 | ||||
Estimated Primary Completion Date | September 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
Detection of diet and drugs effect on response to treatment [ Time Frame: up to 12 months ] Detect diet intake (fatty and spicy meal), drugs use (as NSAIDs, antibiotics, proton pump inhibitors in last month) by Questionnaire.
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Antibiotyping and Prevalence of Virulent Genotypes Among Helicobacter Pylori and Their Impact on Response to Therapy | ||||
Official Title ICMJE | Antibiotyping and Prevalence of Virulent Genotypes Among Helicobacter Pylori and Their Impact on Response to Therapy | ||||
Brief Summary |
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Detailed Description | Helicobacter pylori (H. pylori) infection is one of the most common infections in humans, affecting more than half of the world population. New infections are thought to occur as a consequence of direct human-to-human transmission or environmental contamination. The prevalence of the infection varies widely in rural developing areas (more than 80%) compared to urban developed ones (less than 40%), as a consequence of different socioeconomic and hygienic conditions . The vertical mode is infection spread from ascendant to descendent within the same family, while horizontal transmission involves contact with individuals outside the family or environmental contamination. Most individuals are infected by Helicobacter pylori during early childhood; in developing countries. Successful eradication is important to prevent the development of antibiotic resistance, as well as to reduce the number of treatments and procedures. Thus, national/ regional antibiotic resistance data could be used to guide treatment regimens for H pylori infection . Several clinical factors associated with increased rates of antibiotic resistant H. pylori, including history of previous antibiotic exposure, increasing age, female gender, ethnicity/race, extent of alcohol use, and non-ulcer dyspepsia . The primary antibiotic resistance of H. pylori is increasing worldwide. The overall resistance rate was found to be 4.55% for amoxicillin; 27.22% for clarithromycin; 39.66% for metronidazole; and 22.48% for levofloxacin. Therefore, drug susceptibility result of these antibiotics is necessary to select the appropriate drug for the successful eradication of the infection. Helicobacter pylori exhibit specific geographic distributions that are related to clinical outcomes. Despite the high infection rate of H. pylori throughout the world, the genetic epidemiology surveillance of H. pylori still needs to be improved. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Histopathological examination Of gastric endoscopic biopsies Detection of cag A and vac A Genotypes by PCR in endoscopic biopsies Culture and sensitivity of endoscopic biopsies. Start empirical antibiotics regimens patient triple therapy ((levofloxacin 400 mg once , amoxicillin 1000 mg twice for 2 weeks) and (Proton pump inhibitor twice for 1 month)) then follow up by H. pylori Ag in stool. Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | H Pylori Infection | ||||
Intervention ICMJE |
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Study Arms ICMJE | One group of naive H.Pylori infection will submitted for upper endoscopy.
Upper endoscopy will be done under complete septic condition and multiple gastric biopsies from corpus and antrum will be taken for :
Interventions:
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE |
100 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | October 2023 | ||||
Estimated Primary Completion Date | September 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: - Any patient is above 18 years old with symptomatic H pylori infection patients diagnosed by positive H pylori Ag in stool (naïve treatment). Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Egypt | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05444439 | ||||
Other Study ID Numbers ICMJE | APVGHP | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Nariman Zaghloul Bekhiet, Assiut University | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Assiut University | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Assiut University | ||||
Verification Date | June 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |