Helicobacter Pylori InfectionNCT05830357
Prevalence and Risk Factors of Helicobacter Pylori Infection in Children and Young Adults
An observational study of Helicobacter Pylori Infection, run by Sohag University at 1 site in Egypt.
Trial summary
Helicobacter pylori is a gram-negative bacterium that resides in the stomach and can cause inflammation leading to long-term effects, such as gastric ulcers, cancer, and lymphoma of the stomach mucosal linings Previous research and analysis of H. Read more about this study
- Who is it for?
- Ages 2 to 25 years
- Conditions the study is for
- Helicobacter Pylori Infection
- How many people
- 667 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 30 Sep 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 2 to 25 years
- All sexes
- Child, Adult
Study population: Study population will be chosen by random sampling technique among children and young adults (between 2 to 25 years old) attending internal medicine and pediatric out- patient clinics at Sohag University hospital.
Who may be able to join
- children and young adults (between 2 to 25 years old)
Who cannot join
- children below 2 years old
- adults more than 25 years old
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine-Sohag university
Sohag, 093
Maha Ayman Thabet, 01556073331 ext. +20, mahaayman@med.sohag.edu.eg
About this study
Official title: Prevalence and Risk Factors of Helicobacter Pylori Infection in Children and Young Adults in Sohag Governorate
Helicobacter pylori is a gram-negative bacterium that resides in the stomach and can cause inflammation leading to long-term effects, such as gastric ulcers, cancer, and lymphoma of the stomach mucosal linings Previous research and analysis of H. pylori prevalence in populations have examined common risk factors that increase the likelihood of acquiring the bacteria. Some of the most commonly identified risk factors across various studies in different geographic populations are larger family size, less education, lower socioeconomic status, less frequent hygiene practices, and lower sanitation with specific emphasis on sources of water and defecation.
aim of the work: Studying prevalence of Helicobacter Pylori infection and its related risk factors in children and young adults in Sohag governorate.
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, dyspepsia, children, young adults, prevalence, peptic ulcer, risk factors
- Medical subject headings
- Dyspepsia, Peptic Ulcer
What is being measured
The primary outcome is the main question the study is designed to answer.
Studying prevalence of Helicobacter Pylori infection in children and young adults in Sohag governorate
determine the prevalence of Helicobacter Pylori infection in children and young adults in Sohag governorate by examining stool samples from 667 patients to detect h.pylori antigen
Measured: 12 weeks following the startpoint of the study.
Secondary outcomes (1)
detecting risk factors related to Helicobacter Pylori infection in children and young adults in sohag governorate
We will use a semi-structured questionnaire to detect helicobacter pylori risk factors which include the following : Socio-demographic data, personal habits, physical activity and exercises, history of symptoms suggesting helicopter pylori infection like episodes of epigastric pain, vomiting and dyspepsia and family history, medication and comorbidities .
Measured: 12 weeks following the startpoint 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 posted26 Apr 2023
- Study start1 May 2023 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 667 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Ayman Thabet, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830357
- Sponsor's protocol ID
- Soh-Med-23-04-15MS
- Status last verified
- Apr 2023
- First submitted
- 14 Apr 2023
- Last updated
- 26 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risk Factors of Helicobacter Pylori Infection in Children and Young Adults in Sohag Governorate
- ClinicalTrials.gov ID
- NCT05830357
- Acronym / sponsor ID
- Soh-Med-23-04-15MS
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, dyspepsia, children, young adults, prevalence, peptic ulcer, risk factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 667 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 26 Apr 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.
Helicobacter pylori is a gram-negative bacterium that resides in the stomach and can cause inflammation leading to long-term effects, such as gastric ulcers, cancer, and lymphoma of the stomach mucosal linings Previous research and analysis of H. pylori prevalence in populations have examined common risk factors that increase the likelihood of acquiring the bacteria. Some of the most commonly identified risk factors across various studies in different geographic populations are larger family size, less education, lower socioeconomic status, less frequent hygiene practices, and lower sanitation with specific emphasis on sources of water and defecation.
aim of the work: Studying prevalence of Helicobacter Pylori infection and its related risk factors in children and young adults in Sohag governorate.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 to 25 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Study population will be chosen by random sampling technique among children and young adults (between 2 to 25 years old) attending internal medicine and pediatric out- patient clinics at Sohag University hospital.
Key inclusion criteria (1 listed)
- children and young adults (between 2 to 25 years old)
Key exclusion criteria (2 listed)
- children below 2 years old
- adults more than 25 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Studying prevalence of Helicobacter Pylori infection in children and young adults in Sohag governorate
Time frame: 12 weeks following the startpoint of the study.
determine the prevalence of Helicobacter Pylori infection in children and young adults in Sohag governorate by examining stool samples from 667 patients to detect h.pylori antigen
1 secondary outcome
detecting risk factors related to Helicobacter Pylori infection in children and young adults in sohag governorate
Time frame: 12 weeks following the startpoint 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 26 Apr 2023.
- Individual participant dataSharing planned: Undecided. undecided
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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 Helicobacter Pylori Infection, 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 2 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 26 Apr 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 Maha Ayman Thabet (01556073331 ext. +20, mahaayman@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Studying prevalence of Helicobacter Pylori infection in children and young adults in Sohag governorate (time frame: 12 weeks following the startpoint 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 26 Apr 2023.