Helicobacter Pylori in Patients With Chronic Tonsillits Prepared for Tonsillectomy

October 31, 2023 updated by: Mohamed Fathy Abdelsattar, Sohag University

Tonsillar disorders are frequent In both pediatric and adult otolaryngological practice, . Numerous disorders that damage tonsillar tissue necessitate tonsillectomy. Tonsillectomy is typically required for recurrent tonsillitis. (Mani et al., 2019).

According to studies, the mucosa-associated lymphoid tissue (MALT) of the stomach and tonsillar tissue in the Waldeyer's ring are both lymphoid tissues (Ma et al., 2018).

One of the most prevalent and frequent conditions in otorhinolaryngology is chronic tonsillitis, which is mostly brought on by bacterial infection. Chronic tonsillitis attacks can affect not only the tonsillar tissue but also can contribute to the emergence and progression of systemic disorders (Alrayah.,2023).

A gram-negative, urease-producing bacterium called Helicobacter pylori colonizes the mucosa of the digestive tract. It has been linked to gastric malignancies, notably mucosa-associated lymphoid tissue (MALT) lymphoma, as well as gastric ulcers and duodenal ulcers (Kusters et al., 2006).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mohamed a abdel kader, professor

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag University Hospital
        • Contact:
          • Magdy M Amin, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age: 5 to 50 years.
  2. Of both sex.
  3. Diagnosed with chronic tonsillitis undergoing elective tonsillectomy

Exclusion Criteria:

  1. Patients on proton pump inhibitor or antibiotics 2 weeks before surgery .
  2. Immune-compromised patients.
  3. Patients with obstructive sleep apnea candidates for adenotonsillectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
positive or negative h pylori infection in tonsillar tissue after tonsillectomy
Time Frame: 6 months

Tonsillectomy will be done with the dissection method and one tonsil per patient will be collected. A 2 mm gross specimen will be washed with normal saline. The specimen will be placed in a test tube well containing Rapid Urease Enzyme (GASTRO CURE SYSTEM RUT DRY TEST Batch No. A1060).

The initial color will be read at 0 min. Subsequent color changes will be read at 30 min, 6 hours, and 24 hours. Any color change from the initial yellow color to either pink or red will be recorded as positive. Any test that will be remained yellow after 24 hours will be recorded as negative. No readings will be taken after 24 hours.

Histopathology:

Tonsillar tissue samples will be fixed in 10% formalin for 24 h. Each slide will be separately evaluated for the presence or absence of Helicobacter-like organisms at a high-power magnification
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

October 31, 2023

First Submitted That Met QC Criteria

October 31, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • soh-Med-23-10-06 MS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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