Stool Antigen In Diagnosis Of Helicobacter Pylori

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05802732
Collaborator
(none)
63
1
15
4.2

Study Details

Study Description

Brief Summary

Helicobacter pylori is among the most common bacterial infections in humans. Helicobacter pylori is a Gram-negative, S -shaped rod .The most likely mode of transmission is fecal-oral or oral-oral. Helicobacter pylori infection is acquired in early life and continues to have a high prevalence, especially in developing countries. Growing antibiotic-resistant strains necessitate adapted treatments. The majority of children with Helicobacter pylori infection remain asymptomatic, although a percentage of the infected children do develop Helicobacter. pylori-associated diseases. Helicobacter pylori is closely associated with the development of gastritis, gastric or duodenal ulcers. Helicobacter pylori infection can manifest with abdominal pain or vomiting and, less often, refractory iron deficiency anemia or growth retardation. Helicobacter pylori can be associated, though rarely, with chronic autoimmune thrombocytopenia. Anemia, idiopathic thrombocytopenic purpura, short stature, and sudden infant death syndrome (SIDS) have also been reported as possible extra-gastric manifestations of Helicobacter pylori infection . The diagnosis of Helicobacter pylori infection is made histologically by demonstrating the organism in the biopsy specimens. 13 C-urea breath tests and stool antigen tests are reliable noninvasive methods of detecting Helicobacter pylori infection in patients who do not require endoscopic evaluation. However, some guidelines recommend that non-invasive assessment methods are reserved to determine whether Helicobacter pylori has been eradicated not for diagnosis .However Helicobacter pylori-associated gastritis may, however, be an incidental histopathologic finding during upper endoscopy performed for unrelated indications such as the diagnosis of inflammatory bowel disease, or celiac disease.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Stool Antigen test

Study Design

Study Type:
Observational
Anticipated Enrollment :
63 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Diagnostic Accuracy Of Stool Antigen In Diagnosis Of Helicobacter Pylori Infection In Children
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Outcome Measures

Primary Outcome Measures

  1. detect the diagnostic accuracy of stool Ag test in diagnosis of H.pylori infction in children and adolescents [over one year]

    Patients presented with chronic or recurrent unexplained dyspeptic symptoms and/or non variceal hematemesis will be submitted for stool antigen test

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. Children and adolescents between 4 and 18 years old having chronic or reccurent unexplained dyspeptic symptoms (epigastric pain, post prandial fullness, early satiety, bleching, heart burn, bloating, flatulence, regurgitation, nausea, vomiting and/ or halitosis)(Miwa et al.,2012) and/ or non variceal hematemesis
  1. The dyspeptic symptoms should be present at least 2months duration , which doesn't need to be consecutive, during the previous 6 months.(Rasquin et al., 2006)
Exclusion Criteria:
    1. Patients who received anti sectertory drugs and/ or antibiotics in the previous 4 weeks before endoscopy.
  1. Patients less than 4years and more than 18 years old.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut University Hospital Assiut Egypt

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yosra Alaa Abd El-baset Ali Khallaf, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05802732
Other Study ID Numbers:
  • DAOSADOHPIC
First Posted:
Apr 6, 2023
Last Update Posted:
Apr 6, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2023