Autoimmune DiseasesPM_in_AIGNCT05238181
Pyloric or Pseudopyloric Metaplasia of the Corpus Mucosa in Autoimmune Gastritis
An observational study of Autoimmune Diseases and Helicobacter Pylori Gastritis, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
The study is aimed to investigate the different rates of pyloric/ pseudopyloric metaplasia or spasmolytic polypeptide-expressing metaplasia (SPEM) of corpus between autoimmune gastritis and H. pylori-infected non-ulcer dyspepsia. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Autoimmune Diseases, Helicobacter Pylori Gastritis, Anemia, Pernicious
- What is being tested?
- Assess pyloric or pseudopyloric metaplasia of corpus by H&E stains, Assess pyloric or pseudopyloric metaplasia of corpus by TFF2 immunohistochemistry stains and The assessment of corpus-predominant gastritis index (CGI), Operative Link for Gastritis Assessment (OLGA), and Operative Link on Gastric Intestinal Metaplasia assessment (OLGIM)
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2022to 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients at the outpatient department or at the inpatient wards of National Cheng Kung University Hospital and Tainan hospital in Tainan, Taiwan, will be selected.
Who may be able to join
- Patients who present with relevant symptoms or signs of upper gastrointestinal diseases, including, but not limited to the following: impaired gastric emptying, epigastric discomfort, postprandial bloating, early satiety, epigastric pain, acid regurgitation, dyspepsia, anemia, or vitamin B12 deficiency, or iron deficiency, are candidates to be enrolled to receive gastroscopy.
Who cannot join
- The exclusion criteria are as follows including use of aspirin, non-steroidal anti-inflammatory drugs, or cyclooxygenase-2 selective inhibitors for more than 3 months, or diagnosis with upper gastrointestinal cancer including esophagus, stomach, duodenum, mucosa-associated lymphoid tissue lymphoma, other gastric lymphoma, or pancreas.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Validate That Pyloric or Pseudopyloric Metaplasia of the Corpus Mucosa is a Specific Pathological Feature of Autoimmune Gastritis
The study is aimed to investigate the different rates of pyloric/ pseudopyloric metaplasia or spasmolytic polypeptide-expressing metaplasia (SPEM) of corpus between autoimmune gastritis and H. pylori-infected non-ulcer dyspepsia.
Read the detailed description
Autoimmune gastritis is not an uncommon disease among northern European ancestry, but its prevalence rates are unclear in other populations, including Taiwanese. A study showed that near 2% of persons more than 60 years old have undiagnosed pernicious anemia, one of the complications of autoimmune gastritis. Believed to be undiagnosed, patients are at risk of gastric malignancy and vitamin B12 deficiency-related complications until the end stage. Therefore, use of available diagnostic tools to diagnose patients with autoimmune gastritis has been important. However, autoimmune gastritis has a silent course and is not easy to be early recognized. Early recognition is important because in the late stage, vitamin B12 replacement treatment may correct pernicious anemia only but not neurologic disorders. Fundus and corpus atrophy with parietal cells loss presented 2 to 3 decades before anemia develops in autoimmune gastritis. It is no doubt that autoimmune gastritis could be diagnosed if vitamin B12 deficiency with megaloblastosis and anemia developed; however, it could be diagnosed earlier if the gastric pathological finding was noticed to be a diagnostic clue. Nevertheless, fundus and corpus atrophy is presented not only in autoimmune gastritis but also in H. pylori-related gastropathy. Therefore, we need a pathologic feature which could help physicians differentiate autoimmune gastritis from H. pylori-infected gastropathy. Here, we propose that pyloric or pseudopyloric metaplasia of corpus is distinct from H. pylori-infected gastropathy. We believe that this specific pathologic feature will be helpful to diagnose patients with autoimmune gastritis.
- Conditions
- Autoimmune Diseases, Helicobacter Pylori Gastritis, Anemia, Pernicious, Metaplasia, Gastritis, Atrophic
- Being tested
- Assess pyloric or pseudopyloric metaplasia of corpus by H&E stains, Assess pyloric or pseudopyloric metaplasia of corpus by TFF2 immunohistochemistry stains, The assessment of corpus-predominant gastritis index (CGI), Operative Link for Gastritis Assessment (OLGA), and Operative Link on Gastric Intestinal Metaplasia assessment (OLGIM)
- Keywords
- Anemia, Pernicious, Helicobacter Pylori Gastritis, Metaplasia Intestinal, Metaplasia, Autoimmune Diseases
- Medical subject headings
- Autoimmune Diseases, Anemia, Pernicious, Metaplasia, Gastritis, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assess pyloric or pseudopyloric metaplasia of corpus by H&E stainsDiagnostic test
Also called H&E stains
The pathologists assess pyloric or pseudopyloric metaplasia. Pyloric or pseudopyloric metaplasia of corpus is defined as the presence of torturous deep glands in a "pseudo-pylori" pattern with focal or complete loss of parietal cells. The score of pyloric or pseudopyloric metaplasia of the corpus mucosa is ranging from 0 to 3. Score 0 is no loss of parietal cells with normal fundus gland patterns. Score 1 presents focal loss of parietal cells and scattered patterns of pyloric or pseudopyloric metaplasia with few forming pylorus-like glands. Score 2 presents focal loss of parietal cells and scattered patterns of pyloric or pseudopyloric metaplasia mixed with >= 4 pylorus-like glands. Score 3 was clusters of pylorus-like glands; the metaplasia involves > 60% of mucosa and extends to the lower third of mucosa.
Assess pyloric or pseudopyloric metaplasia of corpus by TFF2 immunohistochemistry stainsDiagnostic test
Also called TFF2 immunohistochemistry stains
Mouse anti-human TFF2 monoclonal antibody (R\&D Systems) is used to stain gastric corpus tissues to assess the presence and degree of SPEM. The score of TFF2 staining of the corpus mucosa is ranging from 0 to 3. Score 0 is not stained. Score 1 is a "scattered" pattern of TFF staining between parietal cells; the staining is limited in the middle third of the mucosa. Score 2 is TFF2-expressing cells distributed over both the middle and lower third of the glands. Score 3 is torturous gastric oxyntic glands with a diffuse expression of TFF2 into the whole glands over both the middle and lower third of the glands of the mucosa.
The assessment of corpus-predominant gastritis index (CGI), Operative Link for Gastritis Assessment (OLGA), and Operative Link on Gastric Intestinal Metaplasia assessment (OLGIM)Diagnostic test
Also called updated Sydney system
We take five gastric mucosal biopsies in each patient under gastroscopy, including two from the antrum (at the lesser and greater curvature, 2 cm within the pylorus, respectively), two from the corpus (at the lesser curvature of the lower corpus and the greater curvature of the middle corpus, respectively), and one from the lesser curvature of the high corpus.
The pathologists assess the gastric pathology according to the updated Sydney system. Accordingly, the histological findings are translated into CGI, the Operative Link for Gastritis Assessment (OLGA), and the Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM) stages.
| Study group | Role | What they receive |
|---|---|---|
| The autoimmune gastritis group | Autoimmune gastritis is diagnosed if the anti-parietal cell antibody titer is positive and higher than 1:10 (ImmuGloTM COMVI mouse kidney/stomach IFA kit, Immco Diagnostics, Inc. Buffalo NY, USA). Receives: Diagnostic Test: Assess pyloric or pseudopyloric metaplasia of corpus by H&E stains; Diagnostic Test: Assess pyloric or pseudopyloric metaplasia of corpus by TFF2 immunohistochemistry stains; Diagnostic Test: The assessment of corpus-predominant gastritis index (CGI), Operative Link for Gastritis Assessment (OLGA), and Operative Link on Gastric Intestinal Metaplasia assessment (OLGIM) | |
| The controls | The patients who are enrolled to validate pathogenesis after H. pylori infection. H. pylori infection is diagnosed by histological assessment. The matched controls are needed to be confirmed to have negative anti-parietal cell antibody. Receives: Diagnostic Test: Assess pyloric or pseudopyloric metaplasia of corpus by H&E stains; Diagnostic Test: Assess pyloric or pseudopyloric metaplasia of corpus by TFF2 immunohistochemistry stains; Diagnostic Test: The assessment of corpus-predominant gastritis index (CGI), Operative Link for Gastritis Assessment (OLGA), and Operative Link on Gastric Intestinal Metaplasia assessment (OLGIM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pyloric or pseudopyloric metaplasia of corpus by positive TFF2 staining
The rates of pyloric or pseudopyloric metaplasia of corpus defined by positive TFF2 staining are compared between the two groups
Measured: 1 to 3 months after gastric biopsy
The pyloric or pseudopyloric metaplasia of corpus by H&E staining
The rates of pyloric or pseudopyloric metaplasia of corpus defined by H\&E staining are compared between the two groups.
Measured: 7 days after gastric biopsy
Secondary outcomes (3)
The positive corpus-predominant gastritis index
The rates of positive corpus-predominant gastritis index defined by updated Sydney system are compared between the two groups.
Measured: 7 days after gastric biopsy
The stages of the Operative Link for Gastritis Assessment (OLGA)
The stages of the Operative Link for Gastritis Assessment (OLGA) defined by updated Sydney are compared between the two groups.
Measured: 7 days after gastric biopsy
The stages of the Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM)
The stages of the Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM) defined by updated Sydney are compared between the two groups.
Measured: 7 days after gastric biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start1 Jan 2022
- Primary completion31 Dec 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 (3)Papers the sponsor has linked to this study.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tainan Hospital, Ministry of Health and Welfare
- Responsible party
- Principal investigator, Hsiu-Chi Cheng, National Cheng-Kung University Hospital
- Investigators
- Hsiu-Chi Cheng, MD, PhD, Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238181
- Sponsor's protocol ID
- B-ER-110-440
- Acronym
- PM_in_AIG
- Status last verified
- Oct 2023
- First submitted
- 3 Feb 2022
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wada Y, Nakajima S, Kushima R, Takemura S, Mori N, Hasegawa H, Nakayama T, Mukaisho KI, Yoshida A, Umano S, Yamamoto K, Sugihara H, Murakami K. Pyloric, pseudopyloric, and spasmolytic polypeptide-expressing metaplasias in autoimmune gastritis: a case series of 22 Japanese patients. Virchows Arch. 2021 Jul;479(1):169-178. doi: 10.1007/s00428-021-03033-5. Epub 2021 Jan 30.
PubMed 33515301Tsai YC, Hsiao WH, Yang HB, Cheng HC, Chang WL, Lu CC, Sheu BS. The corpus-predominant gastritis index may serve as an early marker of Helicobacter pylori-infected patients at risk of gastric cancer. Aliment Pharmacol Ther. 2013 May;37(10):969-78. doi: 10.1111/apt.12291. Epub 2013 Apr 2.
PubMed 23550594Cheng HC, Tsai YC, Yang HB, Yeh YC, Chang WL, Kuo HY, Lu CC, Sheu BS. The corpus-predominant gastritis index can be an early and reversible marker to identify the gastric cancer risk of Helicobacter pylori-infected nonulcer dyspepsia. Helicobacter. 2017 Aug;22(4). doi: 10.1111/hel.12385. Epub 2017 Mar 22.
PubMed 28326664
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Validate That Pyloric or Pseudopyloric Metaplasia of the Corpus Mucosa is a Specific Pathological Feature of Autoimmune Gastritis
- ClinicalTrials.gov ID
- NCT05238181
- Acronym / sponsor ID
- PM_in_AIG / B-ER-110-440
- Conditions
- Autoimmune Diseases, Helicobacter Pylori Gastritis, Anemia, Pernicious, Metaplasia, Gastritis, Atrophic
- Keywords
- Anemia, Pernicious, Helicobacter Pylori Gastritis, Metaplasia Intestinal, Metaplasia, Autoimmune Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Collaborators
- Tainan Hospital, Ministry of Health and Welfare
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Feb 2022 (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 study is aimed to investigate the different rates of pyloric/ pseudopyloric metaplasia or spasmolytic polypeptide-expressing metaplasia (SPEM) of corpus between autoimmune gastritis and H. pylori-infected non-ulcer dyspepsia.
Detailed description
Autoimmune gastritis is not an uncommon disease among northern European ancestry, but its prevalence rates are unclear in other populations, including Taiwanese. A study showed that near 2% of persons more than 60 years old have undiagnosed pernicious anemia, one of the complications of autoimmune gastritis. Believed to be undiagnosed, patients are at risk of gastric malignancy and vitamin B12 deficiency-related complications until the end stage. Therefore, use of available diagnostic tools to diagnose patients with autoimmune gastritis has been important. However, autoimmune gastritis has a silent course and is not easy to be early recognized. Early recognition is important because in the late stage, vitamin B12 replacement treatment may correct pernicious anemia only but not neurologic disorders. Fundus and corpus atrophy with parietal cells loss presented 2 to 3 decades before anemia develops in autoimmune gastritis. It is no doubt that autoimmune gastritis could be diagnosed if vitamin B12 deficiency with megaloblastosis and anemia developed; however, it could be diagnosed earlier if the gastric pathological finding was noticed to be a diagnostic clue. Nevertheless, fundus and corpus atrophy is presented not only in autoimmune gastritis but also in H. pylori-related gastropathy. Therefore, we need a pathologic feature which could help physicians differentiate autoimmune gastritis from H. pylori-infected gastropathy. Here, we propose that pyloric or pseudopyloric metaplasia of corpus is distinct from H. pylori-infected gastropathy. We believe that this specific pathologic feature will be helpful to diagnose patients with autoimmune gastritis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The autoimmune gastritis group | – | Diagnostic Test: Assess pyloric or pseudopyloric metaplasia of corpus by H&E stains, Diagnostic Test: Assess pyloric or pseudopyloric metaplasia of corpus by TFF2 immunohistochemistry stains, Diagnostic Test: The assessment of corpus-predominant gastritis index (CGI), Operative Link for Gastritis Assessment (OLGA), and Operative Link on Gastric Intestinal Metaplasia assessment (OLGIM)Autoimmune gastritis is diagnosed if the anti-parietal cell antibody titer is positive and higher than 1:10 (ImmuGloTM COMVI mouse kidney/stomach IFA kit, Immco Diagnostics, Inc. Buffalo NY, USA). |
| The controls | – | Diagnostic Test: Assess pyloric or pseudopyloric metaplasia of corpus by H&E stains, Diagnostic Test: Assess pyloric or pseudopyloric metaplasia of corpus by TFF2 immunohistochemistry stains, Diagnostic Test: The assessment of corpus-predominant gastritis index (CGI), Operative Link for Gastritis Assessment (OLGA), and Operative Link on Gastric Intestinal Metaplasia assessment (OLGIM)The patients who are enrolled to validate pathogenesis after H. pylori infection. H. pylori infection is diagnosed by histological assessment. The matched controls are needed to be confirmed to have negative anti-parietal cell antibody. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients at the outpatient department or at the inpatient wards of National Cheng Kung University Hospital and Tainan hospital in Tainan, Taiwan, will be selected.
Key inclusion criteria (1 listed)
- Patients who present with relevant symptoms or signs of upper gastrointestinal diseases, including, but not limited to the following: impaired gastric emptying, epigastric discomfort, postprandial bloating, early satiety, epigastric pain, acid regurgitation, dyspepsia, anemia, or vitamin B12 deficiency, or iron deficiency, are candidates to be enrolled to receive gastroscopy.
Key exclusion criteria (1 listed)
- The exclusion criteria are as follows including use of aspirin, non-steroidal anti-inflammatory drugs, or cyclooxygenase-2 selective inhibitors for more than 3 months, or diagnosis with upper gastrointestinal cancer including esophagus, stomach, duodenum, mucosa-associated lymphoid tissue lymphoma, other gastric lymphoma, or pancreas.
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 |
|---|---|---|
| Assess pyloric or pseudopyloric metaplasia of corpus by H&E stainsAlso: H&E stainsThe pathologists assess pyloric or pseudopyloric metaplasia. Pyloric or pseudopyloric metaplasia of corpus is defined as the presence of torturous deep glands in a "pseudo-pylori" pattern with focal or complete loss of parietal cells. The score of pyloric or pseudopyloric metaplasia of the corpus mucosa is ranging from 0 to 3. Score 0 is no loss of parietal cells with normal fundus gland patterns. Score 1 presents focal loss of parietal cells and scattered patterns of pyloric or pseudopyloric metaplasia with few forming pylorus-like glands. Score 2 presents focal loss of parietal cells and scattered patterns of pyloric or pseudopyloric metaplasia mixed with >= 4 pylorus-like glands. Score 3 was clusters of pylorus-like glands; the metaplasia involves > 60% of mucosa and extends to the lower third of mucosa. | Diagnostic test | The autoimmune gastritis group, The controls |
| Assess pyloric or pseudopyloric metaplasia of corpus by TFF2 immunohistochemistry stainsAlso: TFF2 immunohistochemistry stainsMouse anti-human TFF2 monoclonal antibody (R\&D Systems) is used to stain gastric corpus tissues to assess the presence and degree of SPEM. The score of TFF2 staining of the corpus mucosa is ranging from 0 to 3. Score 0 is not stained. Score 1 is a "scattered" pattern of TFF staining between parietal cells; the staining is limited in the middle third of the mucosa. Score 2 is TFF2-expressing cells distributed over both the middle and lower third of the glands. Score 3 is torturous gastric oxyntic glands with a diffuse expression of TFF2 into the whole glands over both the middle and lower third of the glands of the mucosa. | Diagnostic test | The autoimmune gastritis group, The controls |
| The assessment of corpus-predominant gastritis index (CGI), Operative Link for Gastritis Assessment (OLGA), and Operative Link on Gastric Intestinal Metaplasia assessment (OLGIM)Also: updated Sydney systemWe take five gastric mucosal biopsies in each patient under gastroscopy, including two from the antrum (at the lesser and greater curvature, 2 cm within the pylorus, respectively), two from the corpus (at the lesser curvature of the lower corpus and the greater curvature of the middle corpus, respectively), and one from the lesser curvature of the high corpus. The pathologists assess the gastric pathology according to the updated Sydney system. Accordingly, the histological findings are translated into CGI, the Operative Link for Gastritis Assessment (OLGA), and the Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM) stages. | Diagnostic test | The autoimmune gastritis group, The controls |
Primary outcome
The pyloric or pseudopyloric metaplasia of corpus by positive TFF2 staining
Time frame: 1 to 3 months after gastric biopsy
The rates of pyloric or pseudopyloric metaplasia of corpus defined by positive TFF2 staining are compared between the two groups
The pyloric or pseudopyloric metaplasia of corpus by H&E staining
Time frame: 7 days after gastric biopsy
The rates of pyloric or pseudopyloric metaplasia of corpus defined by H\&E staining are compared between the two groups.
3 secondary outcomes
The positive corpus-predominant gastritis index
Time frame: 7 days after gastric biopsy
The stages of the Operative Link for Gastritis Assessment (OLGA)
Time frame: 7 days after gastric biopsy
The stages of the Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM)
Time frame: 7 days after gastric biopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Results publication: PubMed 33515301Wada Y, Nakajima S, Kushima R, Takemura S, Mori N, Hasegawa H, Nakayama T, Mukaisho KI, Yoshida A, Umano S, Yamamoto K, Sugihara H, Murakami K. Pyloric, pseudopyloric, and spasmolytic polypeptide-expressing metaplasias in autoimmune gastritis: a case series of 22 Japanese patients. Virchows Arch. 2021 Jul;479(1):169-178. doi: 10.1007/s00428-021-03033-5. Epub 2021 Jan 30.
- Results publication: PubMed 23550594Tsai YC, Hsiao WH, Yang HB, Cheng HC, Chang WL, Lu CC, Sheu BS. The corpus-predominant gastritis index may serve as an early marker of Helicobacter pylori-infected patients at risk of gastric cancer. Aliment Pharmacol Ther. 2013 May;37(10):969-78. doi: 10.1111/apt.12291. Epub 2013 Apr 2.
- Results publication: PubMed 28326664Cheng HC, Tsai YC, Yang HB, Yeh YC, Chang WL, Kuo HY, Lu CC, Sheu BS. The corpus-predominant gastritis index can be an early and reversible marker to identify the gastric cancer risk of Helicobacter pylori-infected nonulcer dyspepsia. Helicobacter. 2017 Aug;22(4). doi: 10.1111/hel.12385. Epub 2017 Mar 22.
- 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.
Hsiu-Chi Cheng, MD, PhD principal investigator
National Cheng-Kung University Hospital
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 Autoimmune Diseases and Helicobacter Pylori Gastritis, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 1 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 3 Oct 2023. 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 Taiwan. 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?
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?
The pyloric or pseudopyloric metaplasia of corpus by positive TFF2 staining (time frame: 1 to 3 months after gastric biopsy). The study lists 2 primary outcomes in all. 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 NCT05238181, which also lists 3 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 3 Oct 2023.