Clinical trial NCT05444439: Antibiotyping and Prevalence of Virulent Genotypes Among Helicobacter Pylori and Their Impact on Response to Therapy
Official title: Antibiotyping and Prevalence of Virulent Genotypes Among Helicobacter Pylori and Their Impact on Response to Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: H Pylori Infection
Keywords: H Pylori Infection
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

Brief summary: * 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: detection of pre treatment antibiotic culture and sensitivity test
timeFrame: up to 12 months
measure: detection of vacuolating cytotoxin A and cytotoxin-associated gene A virulent Helicobacter Pylori genotypes by polymerase chain reaction amplification(PCR)
timeFrame: up to 12 months
measure: Relation of histopathological examination (gastritis classification) to clinical presentation and to resistance.
timeFrame: up to 12 months
Secondary outcomes:
measure: Detection of diet and drugs effect on response to treatment
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Nariman Zaghloul Bekhiet
Study officials:
References:
citation: Liu Y, Wang S, Yang F, Chi W, Ding L, Liu T, Zhu F, Ji D, Zhou J, Fang Y, Zhang J, Xiang P, Zhang Y, Zhao H. Antimicrobial resistance patterns and genetic elements associated with the antibiotic resistance of Helicobacter pylori strains from Shanghai. Gut Pathog. 2022 Mar 30;14(1):14. doi: 10.1186/s13099-022-00488-y.
citation: Deng L, He XY, Tang B, Xiang Y, Yue JJ. An improved quantitative real-time polymerase chain reaction technology for Helicobacter pylori detection in stomach tissue and its application value in clinical precision testing. BMC Biotechnol. 2020 Jun 22;20(1):33. doi: 10.1186/s12896-020-00624-z.
citation: Pokhrel N, Khanal B, Rai K, Subedi M, Bhattarai NR. Application of PCR and Microscopy to Detect Helicobacter pylori in Gastric Biopsy Specimen among Acid Peptic Disorders at Tertiary Care Centre in Eastern Nepal. Can J Infect Dis Med Microbiol. 2019 Feb 5;2019:3695307. doi: 10.1155/2019/3695307. eCollection 2019.