Peptic Ulcer DiseaseNCT02716025
Serum Zinc, Peptic Ulcer Disease and H. Pylori Infection
An observational study of Peptic Ulcer Disease, run by Ain Shams University.
Trial summary
Fifty consecutive patients with symptoms suggestive of peptic ulcer disease were included. All underwent complete clinical evaluation, laboratory investigations, upper gastrointestinal endoscopy and rapid urease test. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Peptic Ulcer Disease
- What is being tested?
- Upper gastrointestinal endoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Aug 2015
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: patients with symptoms suggestive of peptic ulcer disease like epigastric pain, dyspepsia, heartburn who were candidates for upper gastrointestinal endoscopy.
Who may be able to join
- Symptoms suggestive of peptic ulcer disease like epigastric pain, dyspepsia, heartburn
Who cannot join
- Patients who received zinc supplementation, proton pump inhibitors (PPI), non-steroidal anti-inflammatory drugs (NSAIDs)
- Those presented with hematemesis or melena
- Those with chronic liver disease, renal failure, malabsorption or previous gastric surgery
About this study
Fifty consecutive patients with symptoms suggestive of peptic ulcer disease were included. All underwent complete clinical evaluation, laboratory investigations, upper gastrointestinal endoscopy and rapid urease test. Measurement of serum zinc level was done for all the included patients in addition to twenty five age and sex matched healthy control subjects.
- Conditions
- Peptic Ulcer Disease
- Being tested
- Upper gastrointestinal endoscopy
- Medical subject headings
- Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper gastrointestinal endoscopyProcedure or surgery
Thorough examination of the esophagus, stomach and duodenum to the second part was done to all patients using Olympus CV-150 or Pentax EPM-3500.
| Study group | Role | What they receive |
|---|---|---|
| Case Group | Not described Receives: Procedure: Upper gastrointestinal endoscopy | |
| Control Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of positive upper GIT endoscopic findings
Measured: upon endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study startOct 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic Ulcer DiseaseStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Abdelhakam, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02716025
- Sponsor's protocol ID
- 811
- Status last verified
- Mar 2016
- First submitted
- 17 Mar 2016
- Last updated
- 22 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Zinc, Peptic Ulcer Disease and H. Pylori Infection
- ClinicalTrials.gov ID
- NCT02716025
- Acronym / sponsor ID
- 811
- Conditions
- Peptic Ulcer Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 22 Mar 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.
Fifty consecutive patients with symptoms suggestive of peptic ulcer disease were included. All underwent complete clinical evaluation, laboratory investigations, upper gastrointestinal endoscopy and rapid urease test. Measurement of serum zinc level was done for all the included patients in addition to twenty five age and sex matched healthy control subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Group | – | Procedure: Upper gastrointestinal endoscopy |
| Control Group | – | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients with symptoms suggestive of peptic ulcer disease like epigastric pain, dyspepsia, heartburn who were candidates for upper gastrointestinal endoscopy.
Key inclusion criteria (1 listed)
- Symptoms suggestive of peptic ulcer disease like epigastric pain, dyspepsia, heartburn
Key exclusion criteria (3 listed)
- Patients who received zinc supplementation, proton pump inhibitors (PPI), non-steroidal anti-inflammatory drugs (NSAIDs)
- Those presented with hematemesis or melena
- Those with chronic liver disease, renal failure, malabsorption or previous gastric surgery
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 |
|---|---|---|
| Upper gastrointestinal endoscopyThorough examination of the esophagus, stomach and duodenum to the second part was done to all patients using Olympus CV-150 or Pentax EPM-3500. | Procedure or surgery | Case Group |
Primary outcome
Detection of positive upper GIT endoscopic findings
Time frame: upon endoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Peptic Ulcer Disease, run by Ain Shams 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 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: finished, as of the sponsor's last update on 22 Mar 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of positive upper GIT endoscopic findings (time frame: upon endoscopy). 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 22 Mar 2016.