H Pylori InfectionNCT03911791
Screening of Helicobacter Pylori in Children of Positive Infected Mothers
An observational study of H Pylori Infection, run by Assiut University.
Trial summary
Helicobacter pylori is aspiral shaped gram negative organism that colonized the gastric mucosa.it was showen that intra familial infection play role in transmission of H pylori and mother play the key role in transmission . Read more about this study
- Who is it for?
- Ages 1 day to 13 years
- Conditions the study is for
- H Pylori Infection
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 1 Apr 2021
- 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 day to 13 years
- All sexes
- Child
Study population: Cross sectional study
Who may be able to join
- Child with Dyspeptic symptoms
Who cannot join
- malnutrition childs Patient with metabolic disorder
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Screening of Helicobacter Pylori Infection in Children of Positive Infected Mothers
Helicobacter pylori is aspiral shaped gram negative organism that colonized the gastric mucosa.it was showen that intra familial infection play role in transmission of H pylori and mother play the key role in transmission .
Read the detailed description
Prevelance of H pylori infection in children whose mother positive infected is different according to risks factors such as mother education,work out side or not , socioeconomic status, family size and breast feeding or not.H pylori in children can be represent with recurrent abdominal pain ,recurrent diarrhea,repeated vomitting ,pallor ,fulness,non variceal hematemesis,loss of appetite,reterded growth.complication of H pylori include gastric ulcer,duodenal ulcer,gastric atrophy may lead to gastric cancer and intestinal metaplasia.
- Conditions
- H Pylori Infection
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess prevelance of H pylori infection in children born of infected positive mother
By taken children whose mother infected ,how many of them infected by this microbe by taken these child and done the following investigastion as stool antigen test and biobsy if they are postive by test and then follow up by treatment
Measured: Period from April 2019 to April 2020
Asse the effect of Helicobacter pylori infection in children with anemia
By knowing effect of this microbe on growth development of children by measure weigt /height through body mass index and measure heamoglbin level
By taken children whose positive H pylori follow effect of this microbe on heamoglbin level and do investigation as complete blood count By following test such as complete blood count and heamoglbin level and if this microbe increase level of anemia or not
Measured: Period from April 2019 to April 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start1 Apr 2020 (estimated)
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for H Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samaa Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911791
- Sponsor's protocol ID
- Prevelance of H Pylori
- Status last verified
- Mar 2019
- First submitted
- 10 Mar 2019
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Warren JR, Marshall B. Unidentified curved bacilli on gastric epithelium in active chronic gastritis. Lancet. 1983 Jun 4;1(8336):1273-5. No abstract available.
PubMed 6134060Greenberg ER, Chey WD. Defining the role of sequential therapy for H pylori infection. Lancet. 2013 Jan 19;381(9862):180-2. doi: 10.1016/S0140-6736(12)61849-2. Epub 2012 Nov 16. No abstract available.
PubMed 23158881
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Helicobacter Pylori Infection in Children of Positive Infected Mothers
- ClinicalTrials.gov ID
- NCT03911791
- Acronym / sponsor ID
- Prevelance of H Pylori
- Conditions
- H Pylori Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 11 Apr 2019 (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 aspiral shaped gram negative organism that colonized the gastric mucosa.it was showen that intra familial infection play role in transmission of H pylori and mother play the key role in transmission .
Detailed description
Prevelance of H pylori infection in children whose mother positive infected is different according to risks factors such as mother education,work out side or not , socioeconomic status, family size and breast feeding or not.H pylori in children can be represent with recurrent abdominal pain ,recurrent diarrhea,repeated vomitting ,pallor ,fulness,non variceal hematemesis,loss of appetite,reterded growth.complication of H pylori include gastric ulcer,duodenal ulcer,gastric atrophy may lead to gastric cancer and intestinal metaplasia.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 day to 13 years
- Sex
- All
- Age groups
- Child
- Study population
- Cross sectional study
Key inclusion criteria (1 listed)
- Child with Dyspeptic symptoms
Key exclusion criteria (1 listed)
- malnutrition childs Patient with metabolic disorder
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
To assess prevelance of H pylori infection in children born of infected positive mother
Time frame: Period from April 2019 to April 2020
By taken children whose mother infected ,how many of them infected by this microbe by taken these child and done the following investigastion as stool antigen test and biobsy if they are postive by test and then follow up by treatment
Asse the effect of Helicobacter pylori infection in children with anemia
Time frame: Period from April 2019 to April 2020
By knowing effect of this microbe on growth development of children by measure weigt /height through body mass index and measure heamoglbin level By taken children whose positive H pylori follow effect of this microbe on heamoglbin level and do investigation as complete blood count By following test such as complete blood count and heamoglbin level and if this microbe increase level of anemia or not
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Background: PubMed 6134060Warren JR, Marshall B. Unidentified curved bacilli on gastric epithelium in active chronic gastritis. Lancet. 1983 Jun 4;1(8336):1273-5. No abstract available.
- Background: PubMed 23158881Greenberg ER, Chey WD. Defining the role of sequential therapy for H pylori infection. Lancet. 2013 Jan 19;381(9862):180-2. doi: 10.1016/S0140-6736(12)61849-2. Epub 2012 Nov 16. No abstract available.
- Individual participant dataSharing planned: 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.
Questions about this trial
What is this clinical trial studying?
An observational study of H Pylori Infection, run by Assiut University.
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 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Professor Hamdy, Professor (01001296603, Mohamed.ghazali1@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess prevelance of H pylori infection in children born of infected positive mother (time frame: Period from April 2019 to April 2020). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03911791, which also lists 2 linked publications.
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 11 Apr 2019.