Helicobacter Pylori Infection in Patients With Chronic TonsillitsNCT06117956
Helicobacter Pylori in Patients With Chronic Tonsillits Prepared for Tonsillectomy
A study testing Rapid urease test for h pylori in people with Helicobacter Pylori Infection in Patients With Chronic Tonsillits, run by Sohag University at 1 site in Egypt.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 5 to 50 years
- Conditions the study is for
- Helicobacter Pylori Infection in Patients With Chronic Tonsillits
- What is being tested?
- Rapid urease test for h pylori
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: 5 to 50 years.
- Of both sex.
- Diagnosed with chronic tonsillitis undergoing elective tonsillectomy
Who cannot join
- Patients on proton pump inhibitor or antibiotics 2 weeks before surgery .
- Immune-compromised patients.
- Patients with obstructive sleep apnea candidates for adenotonsillectomy
Trial locations and contacts
1 site in 1 country.
Mohamed a abdel kader, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag
Magdy M Amin, professor
About this study
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).
Read more
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).
- Being tested
- Rapid urease test for h pylori
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid urease test for h pyloriDiagnostic test
Also called histopathological study for removed tonsillar tissue after tonsillectomy
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.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
positive or negative h pylori infection in tonsillar tissue after tonsillectomy
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Oct 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori Infection in Patients With Chronic TonsillitsStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fathy Abdelsattar, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117956
- Sponsor's protocol ID
- soh-Med-23-10-06 MS
- Status last verified
- Oct 2023
- First submitted
- 31 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helicobacter Pylori in Patients With Chronic Tonsillits Prepared for Tonsillectomy
- ClinicalTrials.gov ID
- NCT06117956
- Acronym / sponsor ID
- soh-Med-23-10-06 MS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 5 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age: 5 to 50 years.
- Of both sex.
- Diagnosed with chronic tonsillitis undergoing elective tonsillectomy
Key exclusion criteria (3 listed)
- Patients on proton pump inhibitor or antibiotics 2 weeks before surgery .
- Immune-compromised patients.
- Patients with obstructive sleep apnea candidates for adenotonsillectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid urease test for h pyloriAlso: histopathological study for removed tonsillar tissue after tonsillectomyTonsillectomy 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. 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 | Diagnostic test | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed a abdel kader, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid urease test for h pylori in people with Helicobacter Pylori Infection in Patients With Chronic Tonsillits, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed f fathy, resident (01029578650, mohamed-fathy-post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positive or negative h pylori infection in tonsillar tissue after tonsillectomy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.