DyspepsiaNCT02570776
UBT as a Diagnostic Tool for HP Prevalance
An observational study of Dyspepsia, run by National Institute of Liver & GI Diseases, Pakistan at 1 site in Pakistan.
Trial summary
The prevalence of H. pylori infection in Pakistan is unknown and investigators want to assess it in dyspeptic patients utilizing UBT. At the same time investigators want to validate UBT sensitivity and specificity in Pakistani patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspepsia
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- Dec 2013to Feb 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients getting routine upper GI Endoscopy are enrolled and as per routine histopathology samples are taken to assess Helicobacter pylori. This assessment will be done by two independent histopathologists \& later the results will be compared with C14 UBT taking histopathology as gold standard.
Who may be able to join
- Male and female subjects with dyspeptic symptoms (B1 Criteria of FD)
- Subject who has not been treated for H pylori eradication in the past
- Age above 18 years
- No Alarm symptoms of :
- Gastrointestinal Bleeding
- Anemia
Show all 13Show fewer
- Early satiety
- Unexplained weight loss
- Progressive dysphagia
- Odynophagia
- Recurrent vomiting
- Family history of GI malignancy
- Previous GI malignancy
Who cannot join
- Pregnant females
- Use of NSAIDs
- Use of anti- secretory agent (H2 blockers) and proton pump inhibitors in previous 4 weeks
- Use of anti- microbial agents (Clarithromycin, Metronidazole, Amoxacillin, quinalones) or bismuth in last 4 weeks
- .Gastric and/or duodenal erosions or ulcers, polyps or malignancy if noted on endoscopy will be excluded.
- Patients with predominant symptoms or gastro esophageal reflux disease (GERD) or Endoscopic evidence of esophagitis.
- Patients with abnormal upper abdominal ultrasound.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
National Institute of Liver & GI Diseases, Dow University of Health Sciences
Karachi, Sindh, 0042
Zahid Azam, FCPS, MSc, +922199261462, zahid.azam@duhs.edu.pk
Abdullah Khalid, MBBS; FCPS, +922199261462, abdullah.khalid@duhs.edu.pk
About this study
Official title: Prevalence of Helicobacter Pylori Infection in Dyspeptic Adults and Validation of C14 Urea Breath Test (UBT) as a Diagnostic Tool for Helicobacter Pylori Infection in Pakistani Population
The prevalence of H. pylori infection in Pakistan is unknown and investigators want to assess it in dyspeptic patients utilizing UBT. At the same time investigators want to validate UBT sensitivity and specificity in Pakistani patients
Read the detailed description
The non-invasive methods for the diagnosis of Hp are the Urea Breath Test (UBT) and serological tests. The serological tests includes ELISA test in serum for Hp antibody and in stool for Hp antigen. Serum ELISA Hp antibody is not sensitive for showing active infection and the titres do not decrease even after successful eradication. Serology test cannot be used for those who have previously been treated for Hp, as the decline in titre of Hp antibodies is too slow to be of practical use. The stool Hp antigen detection test is more sensitive and specific as it detects bacterial antigens which will only be positive in the presence of Hp. However, it is cumbersome to collect stool and laboratory services are required. The C14 Urea Breath Test (UBT) is an office based test with sensitivity and specificity comparable to that of the stool antigen test. The diagnostic validity of these tests depends on the prevalence of H pylori infection. A higher prevalence would be associated with higher sensitivity and lower specificity. The safety profile of the urea breath test is very favourable, and no major side effects are associated with it. The aims of this study are to estimate H pylori prevalence in Pakistan among the adult dyspeptic population and to validate the sensitivity and specificity UBT in our population
- Conditions
- Dyspepsia
- Keywords
- Helicobacter pylori, UBT, Sensitivity, specificity, prevalence
- Medical subject headings
- Dyspepsia, Hypersensitivity
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 |
|---|---|---|
| observation | Cohort of patients for Endoscopy \& they are assessed for Helicobacter pylori through the histopathology \& also throgh C14 C UBT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of H pylori infection in Pakistani polulation
Prevalence of H pylori will be assessed by UBT \& confirmed with histopathology as gold standard \& sensitivity \& specificity will be calculated.
Measured: 1 day
Secondary outcomes (1)
Sensivity & specificity of Heliprobe (C14 UBT system) in local population
Sensitivity \& specificity will be measured by number of subjects positive based on ROC
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startDec 2013
- Primary completionDec 2015 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Liver & GI Diseases, Pakistan
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Dr. Zahid Azam, National Institute of Liver & GI Diseases, Pakistan
- Investigators
- Zahid Azam, FCPS, MSc, Principal investigator, National Institute of Liver & GI Diseases, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570776
- Sponsor's protocol ID
- PK-13-01
- Status last verified
- Oct 2015
- First submitted
- 7 May 2014
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Helicobacter Pylori Infection in Dyspeptic Adults and Validation of C14 Urea Breath Test (UBT) as a Diagnostic Tool for Helicobacter Pylori Infection in Pakistani Population
- ClinicalTrials.gov ID
- NCT02570776
- Acronym / sponsor ID
- PK-13-01
- Conditions
- Dyspepsia
- Keywords
- Helicobacter pylori, UBT, Sensitivity, specificity, prevalence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Institute of Liver & GI Diseases, PakistanUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 7 Oct 2015 (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 prevalence of H. pylori infection in Pakistan is unknown and investigators want to assess it in dyspeptic patients utilizing UBT. At the same time investigators want to validate UBT sensitivity and specificity in Pakistani patients
Detailed description
The non-invasive methods for the diagnosis of Hp are the Urea Breath Test (UBT) and serological tests. The serological tests includes ELISA test in serum for Hp antibody and in stool for Hp antigen. Serum ELISA Hp antibody is not sensitive for showing active infection and the titres do not decrease even after successful eradication. Serology test cannot be used for those who have previously been treated for Hp, as the decline in titre of Hp antibodies is too slow to be of practical use. The stool Hp antigen detection test is more sensitive and specific as it detects bacterial antigens which will only be positive in the presence of Hp. However, it is cumbersome to collect stool and laboratory services are required. The C14 Urea Breath Test (UBT) is an office based test with sensitivity and specificity comparable to that of the stool antigen test. The diagnostic validity of these tests depends on the prevalence of H pylori infection. A higher prevalence would be associated with higher sensitivity and lower specificity. The safety profile of the urea breath test is very favourable, and no major side effects are associated with it. The aims of this study are to estimate H pylori prevalence in Pakistan among the adult dyspeptic population and to validate the sensitivity and specificity UBT in our population
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observation | – | –Cohort of patients for Endoscopy \& they are assessed for Helicobacter pylori through the histopathology \& also throgh C14 C UBT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients getting routine upper GI Endoscopy are enrolled and as per routine histopathology samples are taken to assess Helicobacter pylori. This assessment will be done by two independent histopathologists \& later the results will be compared with C14 UBT taking histopathology as gold standard.
Key inclusion criteria (13 listed)
- Male and female subjects with dyspeptic symptoms (B1 Criteria of FD)
- Subject who has not been treated for H pylori eradication in the past
- Age above 18 years
- No Alarm symptoms of :
Key exclusion criteria (7 listed)
- Pregnant females
- Use of NSAIDs
- Use of anti- secretory agent (H2 blockers) and proton pump inhibitors in previous 4 weeks
- Use of anti- microbial agents (Clarithromycin, Metronidazole, Amoxacillin, quinalones) or bismuth in last 4 weeks
- .Gastric and/or duodenal erosions or ulcers, polyps or malignancy if noted on endoscopy will be excluded.
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
Prevalence of H pylori infection in Pakistani polulation
Time frame: 1 day
Prevalence of H pylori will be assessed by UBT \& confirmed with histopathology as gold standard \& sensitivity \& specificity will be calculated.
1 secondary outcome
Sensivity & specificity of Heliprobe (C14 UBT system) in local population
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2015.
Related trials for Dyspepsia
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
RecruitingPhase 4
Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
Functional Dyspepsia, Probiotics
RecruitingPhase 2
Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction-H1/H2
Functional Gastrointestinal Disorders
Not yet recruitingObservational study
Interactive Effects of Early-Life Stress, Diet, and Metabolism on Gastrointestinal Dysfunction With Neuropsychiatric Symptoms
Irritable Bowel Syndrome (IBS), Functional Dyspepsia
Active, not recruitingObservational study
Evaluation of the SIMBA Capsule for Small Intestinal Dysbiosis
Irritable Bowel Syndrome, Crohn Disease
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.
National Institute of Liver & GI Diseases, Dow University of Health Sciences
Karachi, Pakistan
Zahid Azam, FCPS, MSc principal investigator
National Institute of Liver & GI Diseases, Dow University of Health Sciences
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, run by National Institute of Liver & GI Diseases, Pakistan at 1 site in Pakistan.
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 13 inclusion and 7 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 7 Oct 2015. 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 Pakistan. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of H pylori infection in Pakistani polulation (time frame: 1 day). 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 7 Oct 2015.