Concomitant Infection of Intestinal Parasites and Helicobacter Pylori

Concomitant Infection of Intestinal Parasites and Helicobacter Pylori in Sohag University Hospital

Intestinal parasitic infections such as Giardia lamblia, Entamoeba histolyica and Enterobius Vermicularis are among the most common infections worldwide.So parasitic infections are considered one of the major health problems in the world especially in developing countries.

Helicobacter pylori is a gram-negative,helical-shaped,motile bacillus bacterium,which colonizes the gastric mucosa.

H.pylori bacterium secretes urease,a special enzyme that converts urea to ammonia.

Ammonia reduces the stomach's acidity .This risk factor allows pathogenic intestinal protozoa such as G.lamblia to take the opportunity to cross through the stomach's increased pH and cause disease.

Study Overview

• Status: Recruiting
• Conditions: Dyspepsia Abdominal Burning Pain Diarrhea Dysentery
• Intervention / Treatment: Diagnostic test: H.pylori stool antigen rapid test and stool parasitological examination

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Asmaa Nabil Abouzeid; Phone Number: 01144306719; Email: asmaanabil@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Asmaa Nabil Abouzeid
    • Contact: Asmaa Nabil Abouzeid; Phone Number: 01144306719; Email: asmaanabil@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Samples will be collected from outpatients complaining of dyspepsia, abdominal burning pain, diarrhea,and dysentery with persons of any age or sex groups from different locations (cities and villages)

Description

Inclusion Criteria:

• patients complaining of dyspepsia , abdominal burning pain,diarrhea,dysentery,of persons of any age or sex group.

Exclusion Criteria:

• patients taking antibiotics within the previous four weeks, proton pump inhibitors within the previous two weeks, or anti-parasitic drugs within the previous two weeks.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
A; 100 positive stool samples for H.pylori	Diagnostic test: H.pylori stool antigen rapid test and stool parasitological examination; 200 stool samples ( 100 positive and 100 negative for H.pylori) after performance of H.pylori stool rapid antigen test then parasitological stool examination will be done
B; 100 negative stool samples for H.pylori	Diagnostic test: H.pylori stool antigen rapid test and stool parasitological examination; 200 stool samples ( 100 positive and 100 negative for H.pylori) after performance of H.pylori stool rapid antigen test then parasitological stool examination will be done

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the prevalence of intestinal parasitic infections among positive and negative H.pylori infected outpatients in Sohag University Hospital	Collection of 200 stool samples (100 positive and 100 negative for H.pylori) then parasitological examination done for all samples	18 weeks following the start point of the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the prevalence of intestinal parasitic infection among H.pylori infected outpatients in Sohag University Hospital	Macroscopic and microscopic examination of 100 positive H.pylori stool samples	18 weeks following the start point of the study

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: May 1, 2022
• First Submitted That Met QC Criteria: May 1, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Helicobacter pylori Intestinal Parasites
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Neurologic Manifestations; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Parasitic Diseases; Dyspepsia; Diarrhea; Pain; Dysentery; Intestinal Diseases, Parasitic
• Other Study ID Numbers: Soh-Med-22-04-15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No