Dyspepsia Abdominal Burning Pain Diarrhea DysenteryNCT05360940
Concomitant Infection of Intestinal Parasites and Helicobacter Pylori
An observational study of Dyspepsia Abdominal Burning Pain Diarrhea Dysentery, run by Sohag University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Dyspepsia Abdominal Burning Pain Diarrhea Dysentery
- What is being tested?
- H.pylori stool antigen rapid test and stool parasitological examination
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2022to Jul 2023
- Phase
- Observational
- 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 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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)
Who may be able to join
- patients complaining of dyspepsia , abdominal burning pain,diarrhea,dysentery,of persons of any age or sex group.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Asmaa Nabil Abouzeid
Sohag
Asmaa Nabil Abouzeid, 01144306719, asmaanabil@med.sohag.edu.eg
About this study
Official title: 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.
- Being tested
- H.pylori stool antigen rapid test and stool parasitological examination
- Keywords
- Helicobacter pylori Intestinal Parasites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H.pylori stool antigen rapid test and stool parasitological examinationDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| A | 100 positive stool samples for H.pylori Receives: Diagnostic Test: H.pylori stool antigen rapid test and stool parasitological examination | |
| B | 100 negative stool samples for H.pylori Receives: Diagnostic Test: H.pylori stool antigen rapid test and stool parasitological examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 weeks following the start point of the study
Secondary outcomes (1)
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
Measured: 18 weeks following the start point of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study startSep 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dyspepsia Abdominal Burning Pain Diarrhea DysenteryStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Nabil Abouzeid, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360940
- Sponsor's protocol ID
- Soh-Med-22-04-15
- Status last verified
- Jul 2022
- First submitted
- 1 May 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concomitant Infection of Intestinal Parasites and Helicobacter Pylori in Sohag University Hospital
- ClinicalTrials.gov ID
- NCT05360940
- Acronym / sponsor ID
- Soh-Med-22-04-15
- Keywords
- Helicobacter pylori Intestinal Parasites
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 4 May 2022 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Diagnostic Test: H.pylori stool antigen rapid test and stool parasitological examination100 positive stool samples for H.pylori |
| B | – | Diagnostic Test: H.pylori stool antigen rapid test and stool parasitological examination100 negative stool samples for H.pylori |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- patients complaining of dyspepsia , abdominal burning pain,diarrhea,dysentery,of persons of any age or sex group.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| H.pylori stool antigen rapid test and stool parasitological examination200 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 | Diagnostic test | A, B |
Primary outcome
Compare the prevalence of intestinal parasitic infections among positive and negative H.pylori infected outpatients in Sohag University Hospital
Time frame: 18 weeks following the start point of the study
Collection of 200 stool samples (100 positive and 100 negative for H.pylori) then parasitological examination done for all samples
1 secondary outcome
Evaluate the prevalence of intestinal parasitic infection among H.pylori infected outpatients in Sohag University Hospital
Time frame: 18 weeks following the start point of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspepsia Abdominal Burning Pain Diarrhea Dysentery, 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 1 inclusion and 1 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 19 Jul 2022. 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 Asmaa Nabil Abouzeid (01144306719, asmaanabil@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the prevalence of intestinal parasitic infections among positive and negative H.pylori infected outpatients in Sohag University Hospital (time frame: 18 weeks following the start point of the study). 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 19 Jul 2022.