DyspepsiaNCT04294823
Sensitivity and Specificity of the Modified Helicobacter Test INFAI
An observational study of Dyspepsia and GERD, run by International Pharmaceutical Consultancy at 1 site in France.
Trial summary
Study to confirm the sensitivity of the C^13-UBT using the new test meal for H. Pylori in patients with dyspepsia and GERD taking PPI Secondary objectives : to compare the sensitivity and specificity of the C^13-UBT using the new test meal and standard test meal for H.Pylori in patients with dyspepsia and GERD taking… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Helicobacter Pylori Diagnostic, Vital signs measurments and endoscopy
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2020to Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A minimum of 57 H. pylori positive patients and a minimum of 57 H. pylori negative patients fulfilling all inclusion criteria and none of the exclusion criteria will be included
Who may be able to join
- Male and female patients of at least 18 years of age.
- All acid-related disorders requiring long-term PPI treatment including functional dyspepsia according Rome IV classification.
- Positive or negative standard 13C-UBT at screening.
- Diagnosis of H. pylori infection confirmed or excluded by combination of culture , histology and rapid** urease test (PyloriTek@, Serim Research Corp., Elkhart, IN, USA) on samples obtained by endoscopy:
- True positive if culture positive and/or positive histology in combination with positive urease test.
- True negative if culture is negative and if histology and/or urease test is negative. True negative if culture not evaluable and both histology and urease test are negative.
- Culture will be based on biopsies from antrum and corpus. Two biopsies will be taken from antrum and corpus for histology. Rapid urease test will be performed on the samples of antrum and corpus. Written informed consent of the patient.
Who cannot join
- Previous H. pylori eradication therapy.
- Intake of PPI off 14 days, 1-12 receptor antagonists 1 day, NSAlDs, antibiotics, antisecretory drugs, bismuth compounds, or sucralfate in the 4 weeks prior to enrolment.
- Manifest coagulopathy or any other disorder according to which endoscopy and/or biopsies are contraindicated.
- Participation in a clinical trial with another not approved drug within 30 days before entering the study and/or previous participation in this study.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sensitivity and Specificity of the Modified Helicobacter Test INFAI Using New Test Meal With Urea Breath Test in Helicobacter Pylori Positive and Negative Patients With Dyspepsia and GERD Taking Proton Pump Inhibitors
Study to confirm the sensitivity of the C^13-UBT using the new test meal for H. Pylori in patients with dyspepsia and GERD taking PPI
Secondary objectives : to compare the sensitivity and specificity of the C^13-UBT using the new test meal and standard test meal for H.Pylori in patients with dyspepsia and GERD taking PPI.
to complete the results of the Helicbacter test INFAI using new test meal for H.Pylori in patients with dyspepsia and GERD taking PPI with :
- Histology score for H.Pylori in antrum an corpus using the updated Sydney System
- Sex,
- Age,
- Body Mass Index (BMI)
Read the detailed description
Helicobacter pylori (H. pylori) infection can be diagnosed by invasive (i.e., endoscopy and biopsy) and non-invasive techniques . The most accurate non-invasive tests for diagnosing active H. pylori are the 13C-urea breath test and the stool antigen test3 Several guidelines for the management of dyspeptic patients in primary care settings recommend the use of non-invasive tests for H. pylori in the initial management of dyspeptic patients (test and treat strategy)3 . This strategy has been tested in a number of clinical settings and has been shown to be effective from both a clinical and a cost perspective The urea breath test (UBT) and the stool antigen test are very sensitive and specific except in patients taking proton pump inhibitors (PPI) 678 In patients taking PPI, a positive test remains reliable for the detection of H. pylori but the number of false negative tests rises dramatically reducing the sensitivity of these tests. PPI are widely available and are over-thecounter agents in some countries (e.g. USA, Sweden). Clinicians are frequently confronted with making a diagnosis of H. pylori infection in patients who may knowingly or unknowingly be taking PPI. Currently available breath and stool tests are reliable 12 - 14 days after discontinuation of the PPI. This results in the cost and inconvenience of another visit and the possibility of symptoms in some patients when the PPI is withdrawn.
Although the exact mechanism by which acid inhibition causes a false negative reaction is unclear, some studies have suggested that acidification of the stomach may reverse the abnormality Results have been inconsistent, however, and how to acidify the stomach and to what extent this should be done is unclear. Standardised test meals are routinely administered with the breath test substrate.
The aim of this study is to assess the sensitivity and specificity of the 13C-urea breath test administered with the new test meal in patients with dyspepsia and GERD taking PPI.
- Being tested
- Helicobacter Pylori Diagnostic, Vital signs measurments, endoscopy, Nexium Pill
- Medical subject headings
- Dyspepsia, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helicobacter Pylori DiagnosticDiagnostic test
Also called Helicobacter test INFAI
Helicobacter Test INFAI with standard test Meal (1g citric acid as test meal and 75 mg C^13 urea)
+ The C^13 UBT with the new test (REFEX). All patients will take Nexium mups (40 mg) orally once daily 30 min before breakfast from day 1 to 28.
Vital signs measurmentsDevice
No description;
endoscopyDiagnostic test
Also called Upper endoscopy
Upper endoscopy where 6 biopsy samples will be obtained . Two biopsies will be taken from antrum and corpus for histology. The biopsies will be stained with Haematoxylin \& Eosin and Giemsa stains, and gastritis wilt be scored using the Updated Sydney System 12,13 Two biopsies will be taken from antrum and corpus for rapid urease test (RUT) and two biopsies will be taken from antrum and corpus for culture. All biopsy samples will be analysed in the local laboratory of the centre.
Nexium PillDrug
patients will take Nexium mups 40 mg orally once daily, 30 min before breakfast Nexium mups 40 mg will be discontinued after Day 28.
| Study group | Role | What they receive |
|---|---|---|
| FRANCE - CHU creteil | An internal physical examination including vital signs measurements and a 13C-UBT with the standard test meal (Helicobacter Test INFAI) will be performed. Patients with a positive UBT will undergo upper endoscopy. All biopsy samples will be analysed in the local laboratory of the centre. Patients with a negative UBT will undergo also upper endoscopy. Endoscopic procedures and subsequent investigations will be identical in patients with a positive and with a negative UBT. H. pylori positive and negative patients will perform the 13 C-UBT breath tests with new test meal on Day 30. The study will be conducted in outpatients. Starting on Day 1, H. pylori positive and negative patients will take Nexium mups 40 mg orally once daily, 30 min before breakfast. Patients will return to the hospital/medical practice for UBT breath tests with new test meal on Day 30. Patients will be followed-up for 7 days after discontinuation of PPI treatment. Receives: Diagnostic Test: Helicobacter Pylori Diagnostic; Device: Vital signs measurments; Diagnostic Test: endoscopy; Drug: Nexium Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
13C-breath test
In every breath sample the 13C02 / total C02 ratio will be determined at baseline and at 30 min after ingestion of the urea-BC solution.
The delta over baseline (DOB) or Aö-value [0/00] will be calculated from the difference of the 13C02 / total C02 ratio 30 min after intake of the BC solution and at baseline. urea- The test for the standard test meal is positive if DOB or the A6-vaIue is greater than 4 0/00.
The test for the new test meal is positive if DOB or the A6-vaiue is greater than 2.5 0/00. Coefficients of correlation between DOB and the histology score for H. pylori in antrum and corpus using the Updated Sydney System, sex, age and BMI.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study startNov 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionFeb 2021 (estimated)
Why it stopped: Administrative delays were too long
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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Pharmaceutical Consultancy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294823
- Sponsor's protocol ID
- HPT30/J/17
- Status last verified
- Sep 2021
- First submitted
- 2 Mar 2020
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity and Specificity of the Modified Helicobacter Test INFAI Using New Test Meal With Urea Breath Test in Helicobacter Pylori Positive and Negative Patients With Dyspepsia and GERD Taking Proton Pump Inhibitors
- ClinicalTrials.gov ID
- NCT04294823
- Acronym / sponsor ID
- HPT30/J/17
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Administrative delays were too long
- Enrolment
- 0 participants (actual)
- Lead sponsor
- International Pharmaceutical ConsultancyUniversity, hospital or other
- Study start
- Nov 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 4 Mar 2020 (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.
Study to confirm the sensitivity of the C^13-UBT using the new test meal for H. Pylori in patients with dyspepsia and GERD taking PPI
Secondary objectives : to compare the sensitivity and specificity of the C^13-UBT using the new test meal and standard test meal for H.Pylori in patients with dyspepsia and GERD taking PPI.
to complete the results of the Helicbacter test INFAI using new test meal for H.Pylori in patients with dyspepsia and GERD taking PPI with :
- Histology score for H.Pylori in antrum an corpus using the updated Sydney System
- Sex,
- Age,
- Body Mass Index (BMI)
Detailed description
Helicobacter pylori (H. pylori) infection can be diagnosed by invasive (i.e., endoscopy and biopsy) and non-invasive techniques . The most accurate non-invasive tests for diagnosing active H. pylori are the 13C-urea breath test and the stool antigen test3 Several guidelines for the management of dyspeptic patients in primary care settings recommend the use of non-invasive tests for H. pylori in the initial management of dyspeptic patients (test and treat strategy)3 . This strategy has been tested in a number of clinical settings and has been shown to be effective from both a clinical and a cost perspective The urea breath test (UBT) and the stool antigen test are very sensitive and specific except in patients taking proton pump inhibitors (PPI) 678 In patients taking PPI, a positive test remains reliable for the detection of H. pylori but the number of false negative tests rises dramatically reducing the sensitivity of these tests. PPI are widely available and are over-thecounter agents in some countries (e.g. USA, Sweden). Clinicians are frequently confronted with making a diagnosis of H. pylori infection in patients who may knowingly or unknowingly be taking PPI. Currently available breath and stool tests are reliable 12 - 14 days after discontinuation of the PPI. This results in the cost and inconvenience of another visit and the possibility of symptoms in some patients when the PPI is withdrawn.
Although the exact mechanism by which acid inhibition causes a false negative reaction is unclear, some studies have suggested that acidification of the stomach may reverse the abnormality Results have been inconsistent, however, and how to acidify the stomach and to what extent this should be done is unclear. Standardised test meals are routinely administered with the breath test substrate.
The aim of this study is to assess the sensitivity and specificity of the 13C-urea breath test administered with the new test meal in patients with dyspepsia and GERD taking PPI.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FRANCE - CHU creteil | – | Diagnostic Test: Helicobacter Pylori Diagnostic, Device: Vital signs measurments, Diagnostic Test: endoscopy, Drug: Nexium PillAn internal physical examination including vital signs measurements and a 13C-UBT with the standard test meal (Helicobacter Test INFAI) will be performed. Patients with a positive UBT will undergo upper endoscopy. All biopsy samples will be analysed in the local laboratory of the centre. Patients with a negative UBT will undergo also upper endoscopy. Endoscopic procedures and subsequent investigations will be identical in patients with a positive and with a negative UBT. H. pylori positive and negative patients will perform the 13 C-UBT breath tests with new test meal on Day 30. The study will be conducted in outpatients. Starting on Day 1, H. pylori positive and negative patients will take Nexium mups 40 mg orally once daily, 30 min before breakfast. Patients will return to the hospital/medical practice for UBT breath tests with new test meal on Day 30. Patients will be followed-up for 7 days after discontinuation of PPI treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A minimum of 57 H. pylori positive patients and a minimum of 57 H. pylori negative patients fulfilling all inclusion criteria and none of the exclusion criteria will be included
Key inclusion criteria (7 listed)
- Male and female patients of at least 18 years of age.
- All acid-related disorders requiring long-term PPI treatment including functional dyspepsia according Rome IV classification.
- Positive or negative standard 13C-UBT at screening.
- Diagnosis of H. pylori infection confirmed or excluded by combination of culture , histology and rapid** urease test (PyloriTek@, Serim Research Corp., Elkhart, IN, USA) on samples obtained by endoscopy:
- True positive if culture positive and/or positive histology in combination with positive urease test.
Key exclusion criteria (5 listed)
- Previous H. pylori eradication therapy.
- Intake of PPI off 14 days, 1-12 receptor antagonists 1 day, NSAlDs, antibiotics, antisecretory drugs, bismuth compounds, or sucralfate in the 4 weeks prior to enrolment.
- Manifest coagulopathy or any other disorder according to which endoscopy and/or biopsies are contraindicated.
- Participation in a clinical trial with another not approved drug within 30 days before entering the study and/or previous participation in this study.
- Pregnancy
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 |
|---|---|---|
| Helicobacter Pylori DiagnosticAlso: Helicobacter test INFAIHelicobacter Test INFAI with standard test Meal (1g citric acid as test meal and 75 mg C^13 urea) + The C^13 UBT with the new test (REFEX). All patients will take Nexium mups (40 mg) orally once daily 30 min before breakfast from day 1 to 28. | Diagnostic test | FRANCE - CHU creteil |
| Vital signs measurmentsNo description; | Device | FRANCE - CHU creteil |
| endoscopyAlso: Upper endoscopyUpper endoscopy where 6 biopsy samples will be obtained . Two biopsies will be taken from antrum and corpus for histology. The biopsies will be stained with Haematoxylin \& Eosin and Giemsa stains, and gastritis wilt be scored using the Updated Sydney System 12,13 Two biopsies will be taken from antrum and corpus for rapid urease test (RUT) and two biopsies will be taken from antrum and corpus for culture. All biopsy samples will be analysed in the local laboratory of the centre. | Diagnostic test | FRANCE - CHU creteil |
| Nexium Pillpatients will take Nexium mups 40 mg orally once daily, 30 min before breakfast Nexium mups 40 mg will be discontinued after Day 28. | Drug | FRANCE - CHU creteil |
Primary outcome
13C-breath test
Time frame: 1 month
In every breath sample the 13C02 / total C02 ratio will be determined at baseline and at 30 min after ingestion of the urea-BC solution. The delta over baseline (DOB) or Aö-value [0/00] will be calculated from the difference of the 13C02 / total C02 ratio 30 min after intake of the BC solution and at baseline. urea- The test for the standard test meal is positive if DOB or the A6-vaIue is greater than 4 0/00. The test for the new test meal is positive if DOB or the A6-vaiue is greater than 2.5 0/00. Coefficients of correlation between DOB and the histology score for H. pylori in antrum and corpus using the Updated Sydney System, sex, age and BMI.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and GERD, run by International Pharmaceutical Consultancy at 1 site in France.
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 7 inclusion and 5 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: withdrawn, as of the sponsor's last update on 10 Sep 2021. 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 France. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
13C-breath test (time frame: 1 month). 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 10 Sep 2021.