Helicobacter Pylori InfectionNCT02654197
Potential Adverse Developmental and Nutritional Consequences of Helicobacter Pylori Infection in Israeli Children
An observational study of Helicobacter Pylori Infection and Iron Deficiency Anemia, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The investigators believe that there is an association between H. pylori infection and nutritional status and between H. pylori infection and cognitive development. The current study will examine this association in Israeli children, aged 6-12 years. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection, Iron Deficiency Anemia, Child Development
- How many people
- 600 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2016to May 2019
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy children aged 6-12 years residing in the catchment areas of primary care clinics in the Hadera sub-district of Israel.
Who may be able to join
- Informed consent by parents/guardians and children
Who cannot join
- Growth retardation history
- History of prior therapy for H. pylori irradiation
- Hematological disorders
- Developmental delays
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Amit Hochberg, MD, 972-4-630-4320, amit.hochberg@gmail.com
Amit Hochberg, MD
About this study
The investigators believe that there is an association between H. pylori infection and nutritional status and between H. pylori infection and cognitive development. The current study will examine this association in Israeli children, aged 6-12 years.
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| H.pylori positive children | Healthy children, 6-12 years old, will undergo screening for H. pylori infection by measuring anti-H. pylori and CagA IgG antibodies in the serum. The status of H. pylori infection will be confirmed using breath test (UBT). Children will be classified as i) H. pylori negative, if they test negative on UBT ii) H. pylori positive- CagA negative, if they test positive on UBT, but lack serum CagA IgG antibodies iii) H. pylori positive- CagA positive, if they are positive for H. pylori on UBT and CagA IgG antibodies. | |
| H.Pylori negative children | Healthy children, 6-12 years old, will undergo screening for H. pylori infection by measuring anti-H. pylori and CagA IgG antibodies in the serum. The status of H. pylori infection will be confirmed using breath test (UBT). Children will be classified as i) H. pylori negative, if they test negative on UBT ii) H. pylori positive- CagA negative, if they test positive on UBT, but lack serum CagA IgG antibodies iii) H. pylori positive- CagA positive, if they are positive for H. pylori on UBT and CagA IgG antibodies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in means of differences in height
The means of the differences in height for age Z score between baseline and follow-up visits
Measured: Two years
Changes in means of differences in weight
The means of the differences in weight for age Z score between baseline and follow-up visits
Measured: Two years
Changes in means of differences in body mass index
The means of the differences in body mass index for age Z score between baseline and follow-up visits
Measured: Two years
Secondary outcomes (1)
Changes in Iron Biomarkers
The means of the differences in iron biomarkers (hemoglobin, ferritin, iron) between baseline and follow-up visits
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654197
- Sponsor's protocol ID
- HYMC-0093-15
- Status last verified
- Dec 2015
- First submitted
- 14 Dec 2015
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Adverse Developmental and Nutritional Consequences of Helicobacter Pylori Infection in Israeli Children
- ClinicalTrials.gov ID
- NCT02654197
- Acronym / sponsor ID
- HYMC-0093-15
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jun 2016
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 13 Jan 2016 (estimated)
- 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.
The investigators believe that there is an association between H. pylori infection and nutritional status and between H. pylori infection and cognitive development. The current study will examine this association in Israeli children, aged 6-12 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| H.pylori positive children | – | –Healthy children, 6-12 years old, will undergo screening for H. pylori infection by measuring anti-H. pylori and CagA IgG antibodies in the serum. The status of H. pylori infection will be confirmed using breath test (UBT). Children will be classified as i) H. pylori negative, if they test negative on UBT ii) H. pylori positive- CagA negative, if they test positive on UBT, but lack serum CagA IgG antibodies iii) H. pylori positive- CagA positive, if they are positive for H. pylori on UBT and CagA IgG antibodies. |
| H.Pylori negative children | – | –Healthy children, 6-12 years old, will undergo screening for H. pylori infection by measuring anti-H. pylori and CagA IgG antibodies in the serum. The status of H. pylori infection will be confirmed using breath test (UBT). Children will be classified as i) H. pylori negative, if they test negative on UBT ii) H. pylori positive- CagA negative, if they test positive on UBT, but lack serum CagA IgG antibodies iii) H. pylori positive- CagA positive, if they are positive for H. pylori on UBT and CagA IgG antibodies. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy children aged 6-12 years residing in the catchment areas of primary care clinics in the Hadera sub-district of Israel.
Key inclusion criteria (1 listed)
- Informed consent by parents/guardians and children
Key exclusion criteria (4 listed)
- Growth retardation history
- History of prior therapy for H. pylori irradiation
- Hematological disorders
- Developmental delays
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
Changes in means of differences in height
Time frame: Two years
The means of the differences in height for age Z score between baseline and follow-up visits
Changes in means of differences in weight
Time frame: Two years
The means of the differences in weight for age Z score between baseline and follow-up visits
Changes in means of differences in body mass index
Time frame: Two years
The means of the differences in body mass index for age Z score between baseline and follow-up visits
1 secondary outcome
Changes in Iron Biomarkers
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
- Individual participant dataSharing planned: No
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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 and Iron Deficiency Anemia, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 4 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 13 Jan 2016. 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 Israel. 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 Amit Hochberg, MD (972-4-6304320, amit.hochberg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in means of differences in height (time frame: Two years). The study lists 3 primary outcomes in all. 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 13 Jan 2016.