Helicobacter Pylori InfectionCIMNCT06273384
Diagnostic Performance of CIM for Helicobacter Pylori Infection in Patients With Peptic Ulcer Bleeding
An observational study of Helicobacter Pylori Infection and Peptic Ulcer Hemorrhage, run by Mahidol University at 1 site in Thailand.
Trial summary
The goal of this cross-sectional study is to evaluate the efficacy of current infection marker (CIM) method for H. pylori detection. The main questions it aims to answer are: To evaluate the efficacy of CIM method for H. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection, Peptic Ulcer Hemorrhage
- How many people
- 135 participants
- Where
- 1 siteThailand
- Study dates
- 1 Mar 2024to 31 Dec 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged 18 years or older, who present with upper gastrointestinal hemorrhage and undergo esophagogastroduodenoscopy, receiving a diagnosis of peptic ulcer, will be recruited and enrolled. The exclusion criteria include patients with inappropriate gastric mucosal biopsy conditions, such as hemodynamic instability, coagulopathy, severe thrombocytopenia, or the presence of massive bloody content in the gastric cavity or duodenum. Additionally, individuals with a previous history of gastric surgery, such as partial or total gastrectomy, will be excluded.
Who may be able to join
- Age ≥ 18 years
- Upper gastrointestinal hemorrhage and undergo esophagogastroduodenoscopy with diagnosis of peptic ulcer
Who cannot join
- Inappropriate gastric mucosal biopsy conditions such as hemodynamic instability, coagulopathy or severe thrombocytopenia or massive bloody content in gastric cavity or duodenum
- Previous history of gastric surgery such as partial or total gastrectomy
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, 10700
About this study
Official title: Diagnostic Performance of Current Infection Marker (CIM) for Helicobacter Pylori Infection in Patients With Peptic Ulcer Bleeding
The goal of this cross-sectional study is to evaluate the efficacy of current infection marker (CIM) method for H. pylori detection. The main questions it aims to answer are:
- To evaluate the efficacy of CIM method for H. pylori detection compared to rapid urease test(RUT), histopathology, polymerase chain reaction (PCR), and urea breath test (UBT) in patients who presented with upper gastrointestinal hemorrhage from peptic ulcer, and their sensitivity, specificity, accuracy, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio, and negative likelihood ratio.
- To evaluate the advantages of CIM method for H. pylori detection comparing to RUT, histopathology, PCR, and UBT in patients who presented with upper gastrointestinal hemorrhage from peptic ulcer as net reclassification index (NRI).
- To study the associated factors in false negative value of H. pylori detection methods with CIM, RUT, histopathology, PCR, and UBT.
Read the detailed description
Helicobacter pylori (H. pylori) is a Gram-negative bacillus that involves gastric mucosa and was first isolated in 1982. The global prevalence of H. pylori infection is about 50% and the prevalence is different in each region of the world. The highest prevalence of H. pylori infection is up to 70.1% in Africa, but the prevalence in the South-East Asian region varies from 28.6 to 70.3%. For Thailand, the prevalence of H. pylori infection was reported approximately 43.6-64.0%. H. pylori infection is also well-known to be associated with gastric cancer, Gastric mucosa-associated lymphoid tissue (MALT) lymphoma, and peptic ulcer.
Peptic ulcer strongly associates with H. pylori infection. The global prevalence of H. pylori infection is 48.5-94.5% and 66.9-95.8% in gastric ulcer and duodenal ulcer, respectively. These data corresponded to the prevalence in Thailand which is 68.9% and 82.8 % in gastric ulcers and duodenal ulcers, respectively. Peptic ulcer is also one of the common causes of upper gastrointestinal hemorrhage. In contrast, H. pylori eradication has been shown to reduce the risk of recurrent upper gastrointestinal bleeding.
Nowadays, there are several tests for H. pylori infection including endoscopic-based methods such as rapid urease test (RUT), histopathology, culture, and polymerase chain reaction (PCR) for deoxyribonucleic acid (DNA) of H. pylori detection, and non-invasive methods, including urea breath test (UBT), fecal antigen test, and serologic test. In clinical practice, patients under upper gastrointestinal endoscopy with suspicion of H. pylori infection are almost always tested with RUT and histopathology. Both these methods are simple and available with high sensitivity and specificity that is greater 90 and 95%, respectively.
Patients presented with upper gastrointestinal bleeding are recommended to be diagnosed and treated with endoscopy, if the peptic ulcer including gastric ulcer or duodenal ulcer was found, the H. pylori infection must be considered to test. Blood in the gastric cavity, proton pump inhibitor (PPI), and antibiotic prescription can decrease the sensitivity and specificity of RUT and histopathology. Moreover, the patients with gastric ulcer and duodenal ulcer should be generally treated with PPI for a total duration of 8 to 12 weeks and 4 to 8 weeks, respectively, which could affect the accuracy of RUT for H. pylori detection. Although PCR technique has more than 98% of sensitivity, specificity, and accuracy, it is very expensive test that requires high performance center, so PCR test is not always available and not suitable for clinical practice. Therefore, these limitations can delay the diagnosis of H. pylori infection in patients with upper gastrointestinal hemorrhage, so the patients are also not treated this infection in timely manner.
Serology test for H. pylori infection is the test for blood immunoglobulin G (IgG) detection that has 85% sensitivity and 79% specificity 26. PPI or antibiotic uses and upper gastrointestinal bleeding do not affect to this test, so this method might be a better test for H. pylori infection than the endoscopic-based tests including RUT or histopathology. Currently, the immunochromatographic test is a novel method for H. pylori infection that identify current infection marker (CIM) of H. pylori. It is a simple and rapid test in which the sensitivity and the specificity in general population are 90 - 92.3% and 89 - 90.5%, respectively. However, the use of CIM for H. pylori infection in patients with upper gastrointestinal hemorrhage from peptic ulcer who are treated with PPI or antibiotic has not been done yet.
This study aims to evaluate the efficacy of CIM for H. pylori infection test in patients with upper gastrointestinal hemorrhage from peptic ulcer compared to rapid urease test, histopathology, PCR for H. pylori detection, and UBT method.
- Keywords
- Helicobacter Pylori Infection, Peptic Ulcer Hemorrhage, Current infection marker
- Medical subject headings
- Peptic Ulcer Hemorrhage
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 |
|---|---|---|
| Intervention group | Patients aged 18 years and older who present with peptic ulcer hemorrhage, confirmed by esophagogastroduodenoscopy (EGD). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of CIM method for H. pylori detection
The sensitivity, specificity, and accuracy of the CIM method for H. pylori detection were compared to those of RUT, histopathology, PCR, and UBT.
Measured: Through study completion, an average of 2 years
Secondary outcomes (1)
The advantages of CIM method for H. pylori detection
The net reclassification index (NRI) of the CIM method for H. pylori detection were compared to those of RUT, histopathology, PCR, and UBT.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Mahidol 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
- Cross-sectional
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Watcharasak Chotiyaputta, Mahidol University
- Investigators
- Monthira Maneerattanaporn, Asso Prof, Principal investigator, Department of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273384
- Sponsor's protocol ID
- Si 062/2023
- Acronym
- CIM
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 6134060Pounder RE, Ng D. The prevalence of Helicobacter pylori infection in different countries. Aliment Pharmacol Ther. 1995;9 Suppl 2:33-9.
PubMed 8547526Hooi JKY, Lai WY, Ng WK, Suen MMY, Underwood FE, Tanyingoh D, Malfertheiner P, Graham DY, Wong VWS, Wu JCY, Chan FKL, Sung JJY, Kaplan GG, Ng SC. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology. 2017 Aug;153(2):420-429. doi: 10.1053/j.gastro.2017.04.022. Epub 2017 Apr 27.
PubMed 28456631Sirinthornpunya S. Prevalence of Helicobacter pylori infection in patients with peptic disease. J Med Assoc Thai. 2012 Mar;95 Suppl 3:S22-7.
PubMed 22619883Hentschel E, Brandstatter G, Dragosics B, Hirschl AM, Nemec H, Schutze K, Taufer M, Wurzer H. Effect of ranitidine and amoxicillin plus metronidazole on the eradication of Helicobacter pylori and the recurrence of duodenal ulcer. N Engl J Med. 1993 Feb 4;328(5):308-12. doi: 10.1056/NEJM199302043280503.
PubMed 8419816Moayyedi P. The health economics of Helicobacter pylori infection. Best Pract Res Clin Gastroenterol. 2007;21(2):347-61. doi: 10.1016/j.bpg.2006.11.004.
PubMed 17382282Ford AC, Moayyedi P. Whom should we "test and treat" for Helicobacter pylori? BMJ. 2014 May 20;348:g3320. doi: 10.1136/bmj.g3320. No abstract available.
PubMed 24846521McColl KE. Clinical practice. Helicobacter pylori infection. N Engl J Med. 2010 Apr 29;362(17):1597-604. doi: 10.1056/NEJMcp1001110. No abstract available.
PubMed 20427808Ciociola AA, McSorley DJ, Turner K, Sykes D, Palmer JB. Helicobacter pylori infection rates in duodenal ulcer patients in the United States may be lower than previously estimated. Am J Gastroenterol. 1999 Jul;94(7):1834-40. doi: 10.1111/j.1572-0241.1999.01214.x.
PubMed 10406244Tsuji H, Kohli Y, Fukumitsu S, Morita K, Kaneko H, Ohkawara T, Minami M, Ueda K, Sawa Y, Matsuzaki H, Morinaga O, Ohkawara Y. Helicobacter pylori-negative gastric and duodenal ulcers. J Gastroenterol. 1999 Aug;34(4):455-60. doi: 10.1007/s005350050296.
PubMed 10452677Vu C, Ng YY. Prevalence of Helicobacter pylori in peptic ulcer disease in a Singapore hospital. Singapore Med J. 2000 Oct;41(10):478-81.
PubMed 11281437Zhang W, Liang X, Chen X, Ge Z, Lu H. Time trends in the prevalence of Helicobacter pylori infection in patients with peptic ulcer disease: a single-center retrospective study in Shanghai. J Int Med Res. 2021 Oct;49(10):3000605211051167. doi: 10.1177/03000605211051167.
PubMed 34686094Lanas A, Chan FKL. Peptic ulcer disease. Lancet. 2017 Aug 5;390(10094):613-624. doi: 10.1016/S0140-6736(16)32404-7. Epub 2017 Feb 25.
PubMed 28242110Jaspersen D, Koerner T, Schorr W, Brennenstuhl M, Raschka C, Hammar CH. Helicobacter pylori eradication reduces the rate of rebleeding in ulcer hemorrhage. Gastrointest Endosc. 1995 Jan;41(1):5-7. doi: 10.1016/s0016-5107(95)70267-9.
PubMed 7698624Rokkas T, Karameris A, Mavrogeorgis A, Rallis E, Giannikos N. Eradication of Helicobacter pylori reduces the possibility of rebleeding in peptic ulcer disease. Gastrointest Endosc. 1995 Jan;41(1):1-4. doi: 10.1016/s0016-5107(95)70266-0.
PubMed 7698617
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of Current Infection Marker (CIM) for Helicobacter Pylori Infection in Patients With Peptic Ulcer Bleeding
- ClinicalTrials.gov ID
- NCT06273384
- Acronym / sponsor ID
- CIM / Si 062/2023
- Keywords
- Helicobacter Pylori Infection, Peptic Ulcer Hemorrhage, Current infection marker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Feb 2024 (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.
The goal of this cross-sectional study is to evaluate the efficacy of current infection marker (CIM) method for H. pylori detection. The main questions it aims to answer are:
- To evaluate the efficacy of CIM method for H. pylori detection compared to rapid urease test(RUT), histopathology, polymerase chain reaction (PCR), and urea breath test (UBT) in patients who presented with upper gastrointestinal hemorrhage from peptic ulcer, and their sensitivity, specificity, accuracy, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio, and negative likelihood ratio.
- To evaluate the advantages of CIM method for H. pylori detection comparing to RUT, histopathology, PCR, and UBT in patients who presented with upper gastrointestinal hemorrhage from peptic ulcer as net reclassification index (NRI).
- To study the associated factors in false negative value of H. pylori detection methods with CIM, RUT, histopathology, PCR, and UBT.
Detailed description
Helicobacter pylori (H. pylori) is a Gram-negative bacillus that involves gastric mucosa and was first isolated in 1982. The global prevalence of H. pylori infection is about 50% and the prevalence is different in each region of the world. The highest prevalence of H. pylori infection is up to 70.1% in Africa, but the prevalence in the South-East Asian region varies from 28.6 to 70.3%. For Thailand, the prevalence of H. pylori infection was reported approximately 43.6-64.0%. H. pylori infection is also well-known to be associated with gastric cancer, Gastric mucosa-associated lymphoid tissue (MALT) lymphoma, and peptic ulcer.
Peptic ulcer strongly associates with H. pylori infection. The global prevalence of H. pylori infection is 48.5-94.5% and 66.9-95.8% in gastric ulcer and duodenal ulcer, respectively. These data corresponded to the prevalence in Thailand which is 68.9% and 82.8 % in gastric ulcers and duodenal ulcers, respectively. Peptic ulcer is also one of the common causes of upper gastrointestinal hemorrhage. In contrast, H. pylori eradication has been shown to reduce the risk of recurrent upper gastrointestinal bleeding.
Nowadays, there are several tests for H. pylori infection including endoscopic-based methods such as rapid urease test (RUT), histopathology, culture, and polymerase chain reaction (PCR) for deoxyribonucleic acid (DNA) of H. pylori detection, and non-invasive methods, including urea breath test (UBT), fecal antigen test, and serologic test. In clinical practice, patients under upper gastrointestinal endoscopy with suspicion of H. pylori infection are almost always tested with RUT and histopathology. Both these methods are simple and available with high sensitivity and specificity that is greater 90 and 95%, respectively.
Patients presented with upper gastrointestinal bleeding are recommended to be diagnosed and treated with endoscopy, if the peptic ulcer including gastric ulcer or duodenal ulcer was found, the H. pylori infection must be considered to test. Blood in the gastric cavity, proton pump inhibitor (PPI), and antibiotic prescription can decrease the sensitivity and specificity of RUT and histopathology. Moreover, the patients with gastric ulcer and duodenal ulcer should be generally treated with PPI for a total duration of 8 to 12 weeks and 4 to 8 weeks, respectively, which could affect the accuracy of RUT for H. pylori detection. Although PCR technique has more than 98% of sensitivity, specificity, and accuracy, it is very expensive test that requires high performance center, so PCR test is not always available and not suitable for clinical practice. Therefore, these limitations can delay the diagnosis of H. pylori infection in patients with upper gastrointestinal hemorrhage, so the patients are also not treated this infection in timely manner.
Serology test for H. pylori infection is the test for blood immunoglobulin G (IgG) detection that has 85% sensitivity and 79% specificity 26. PPI or antibiotic uses and upper gastrointestinal bleeding do not affect to this test, so this method might be a better test for H. pylori infection than the endoscopic-based tests including RUT or histopathology. Currently, the immunochromatographic test is a novel method for H. pylori infection that identify current infection marker (CIM) of H. pylori. It is a simple and rapid test in which the sensitivity and the specificity in general population are 90 - 92.3% and 89 - 90.5%, respectively. However, the use of CIM for H. pylori infection in patients with upper gastrointestinal hemorrhage from peptic ulcer who are treated with PPI or antibiotic has not been done yet.
This study aims to evaluate the efficacy of CIM for H. pylori infection test in patients with upper gastrointestinal hemorrhage from peptic ulcer compared to rapid urease test, histopathology, PCR for H. pylori detection, and UBT method.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | –Patients aged 18 years and older who present with peptic ulcer hemorrhage, confirmed by esophagogastroduodenoscopy (EGD). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years or older, who present with upper gastrointestinal hemorrhage and undergo esophagogastroduodenoscopy, receiving a diagnosis of peptic ulcer, will be recruited and enrolled. The exclusion criteria include patients with inappropriate gastric mucosal biopsy conditions, such as hemodynamic instability, coagulopathy, severe thrombocytopenia, or the presence of massive bloody content in the gastric cavity or duodenum. Additionally, individuals with a previous history of gastric surgery, such as partial or total gastrectomy, will be excluded.
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Upper gastrointestinal hemorrhage and undergo esophagogastroduodenoscopy with diagnosis of peptic ulcer
Key exclusion criteria (2 listed)
- Inappropriate gastric mucosal biopsy conditions such as hemodynamic instability, coagulopathy or severe thrombocytopenia or massive bloody content in gastric cavity or duodenum
- Previous history of gastric surgery such as partial or total gastrectomy
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
The efficacy of CIM method for H. pylori detection
Time frame: Through study completion, an average of 2 years
The sensitivity, specificity, and accuracy of the CIM method for H. pylori detection were compared to those of RUT, histopathology, PCR, and UBT.
1 secondary outcome
The advantages of CIM method for H. pylori detection
Time frame: Through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Results publication: 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.
- Results publication: PubMed 8547526Pounder RE, Ng D. The prevalence of Helicobacter pylori infection in different countries. Aliment Pharmacol Ther. 1995;9 Suppl 2:33-9.
- Results publication: PubMed 28456631Hooi JKY, Lai WY, Ng WK, Suen MMY, Underwood FE, Tanyingoh D, Malfertheiner P, Graham DY, Wong VWS, Wu JCY, Chan FKL, Sung JJY, Kaplan GG, Ng SC. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology. 2017 Aug;153(2):420-429. doi: 10.1053/j.gastro.2017.04.022. Epub 2017 Apr 27.
- Results publication: PubMed 22619883Sirinthornpunya S. Prevalence of Helicobacter pylori infection in patients with peptic disease. J Med Assoc Thai. 2012 Mar;95 Suppl 3:S22-7.
- Results publication: PubMed 8419816Hentschel E, Brandstatter G, Dragosics B, Hirschl AM, Nemec H, Schutze K, Taufer M, Wurzer H. Effect of ranitidine and amoxicillin plus metronidazole on the eradication of Helicobacter pylori and the recurrence of duodenal ulcer. N Engl J Med. 1993 Feb 4;328(5):308-12. doi: 10.1056/NEJM199302043280503.
- Results publication: PubMed 17382282Moayyedi P. The health economics of Helicobacter pylori infection. Best Pract Res Clin Gastroenterol. 2007;21(2):347-61. doi: 10.1016/j.bpg.2006.11.004.
- Results publication: PubMed 24846521Ford AC, Moayyedi P. Whom should we "test and treat" for Helicobacter pylori? BMJ. 2014 May 20;348:g3320. doi: 10.1136/bmj.g3320. No abstract available.
- Results publication: PubMed 20427808McColl KE. Clinical practice. Helicobacter pylori infection. N Engl J Med. 2010 Apr 29;362(17):1597-604. doi: 10.1056/NEJMcp1001110. No abstract available.
- Results publication: PubMed 10406244Ciociola AA, McSorley DJ, Turner K, Sykes D, Palmer JB. Helicobacter pylori infection rates in duodenal ulcer patients in the United States may be lower than previously estimated. Am J Gastroenterol. 1999 Jul;94(7):1834-40. doi: 10.1111/j.1572-0241.1999.01214.x.
- Results publication: PubMed 10452677Tsuji H, Kohli Y, Fukumitsu S, Morita K, Kaneko H, Ohkawara T, Minami M, Ueda K, Sawa Y, Matsuzaki H, Morinaga O, Ohkawara Y. Helicobacter pylori-negative gastric and duodenal ulcers. J Gastroenterol. 1999 Aug;34(4):455-60. doi: 10.1007/s005350050296.
- Results publication: PubMed 11281437Vu C, Ng YY. Prevalence of Helicobacter pylori in peptic ulcer disease in a Singapore hospital. Singapore Med J. 2000 Oct;41(10):478-81.
- Results publication: PubMed 34686094Zhang W, Liang X, Chen X, Ge Z, Lu H. Time trends in the prevalence of Helicobacter pylori infection in patients with peptic ulcer disease: a single-center retrospective study in Shanghai. J Int Med Res. 2021 Oct;49(10):3000605211051167. doi: 10.1177/03000605211051167.
- Individual participant dataSharing planned: No
Related trials for Helicobacter Pylori Infection
RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Helicobacter Infection
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
HELICOBACTER PYLORI INFECTIONS
RecruitingPhase 4
Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
Not yet recruitingObservational study
European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers
Helicobacter Pylori Infection, Colorectal Cancer
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.
Monthira Maneerattanaporn, Asso Prof principal investigator
Department of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand
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 Peptic Ulcer Hemorrhage, run by Mahidol University at 1 site in Thailand.
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 2 inclusion and 2 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 22 Feb 2024. 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 Thailand. 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 Thanapat Atthakitmongkol, MD (66813998583, ben02170@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of CIM method for H. pylori detection (time frame: Through study completion, an average of 2 years). 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 NCT06273384, which also lists 33 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 22 Feb 2024.