Antibiotyping and Prevalence of Virulent Genotypes Among Helicobacter Pylori and Their Impact on Response to Therapy

Assiut University

Status: Not yet enrolling

Conditions: H Pylori Infection

Treatments: Genetic: detection of vacuolating cytotoxin A (Vac A) and cytotoxin-associated gene A (Cag A) virulent H.Pylori genotypes by polymerase chain reaction amplification(PCR) in gastric biopsies :; Diagnostic Test: Culture and sensitivity of endoscopic gastric biopsies:; Drug: empirical H.pylori regimens; Procedure: Upper endoscopy; Diagnostic Test: H.Pylori Ag in stool; Other: Histopathological examination endoscopic gastric biopsies:

Study type: Interventional

Funder types: Other

Identifiers

NCT05444439

APVGHP

Details and patient eligibility

About

• Detection of primary antimicrobial susceptibility and resistance of Helicobacter Pylori infection.
• Detection of resistance and virulence genes of Helicobacter Pylori infection.
• Assessment of H pylori carcinogenicity gene.
• Evaluation of outcome and efficacy of antibiotics regimen will be used in our research.
• Evaluation of effect of other factors as diet (fatty and spicy meal), drugs as NSAIDs use, antibiotics for any cause on response of H pylori to antibiotics regimen.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• Patients who aren't eligible to endoscopy.
• Patients are under 18 years old
• Patient's refusal
• history of antibiotics or proton pump inhibitor use during last month.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

One group of naive H.Pylori infection will submitted for upper endoscopy.

Other group

Description:

Upper endoscopy will be done under complete septic condition and multiple gastric biopsies from corpus and antrum will be taken for : 1. Histopathological examination. 2. Culture and sensitivity of endoscopic biopsies. 3. detection of vacuolating cytotoxin A (Vac A) and cytotoxin-associated gene A (Cag A) virulent Helicobacter Pylori genotypes by polymerase chain reaction amplification(PCR). 4. Then start empirical antibiotics regimens.

Treatment:

Diagnostic Test: Culture and sensitivity of endoscopic gastric biopsies:

Procedure: Upper endoscopy

Other: Histopathological examination endoscopic gastric biopsies:

Diagnostic Test: H.Pylori Ag in stool

Genetic: detection of vacuolating cytotoxin A (Vac A) and cytotoxin-associated gene A (Cag A) virulent H.Pylori genotypes by polymerase chain reaction amplification(PCR) in gastric biopsies :

Drug: empirical H.pylori regimens