Atrophic GastritisNH-GAANCT07388459
Natural History, Evolution, and Clinical Features of Autoimmune Atrophic Gastritis
An observational study of Atrophic Gastritis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
Autoimmune atrophic gastritis (AAG) is an immune-mediated disorder characterized by the loss of oxyntic glands and mucosal atrophy1.Specific autoantibodies directed to gastric parietal cells (PCA) and/or to intrinsic factors are inconstantly present1.Despite its morbidity, data on the epidemiology are scant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrophic Gastritis
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 17 Nov 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 of both genders aged ≥ 18 years with atrophic gastritis being treated at Fondazione IRCCS Policlinico San Matteo
Who may be able to join
- Male or female, age ≥18 years;
- AAG diagnosis is made according to the updated Sydney System criteria referring to a tertiary outpatient clinic dedicated;
- Signed written informed consent.
Who cannot join
- Patients with uncertain histopathological findings;
- Patients with persistent or active Helicobacter pylori infection;
- Patients with long-term proton pump inhibitor users and atrophic pangastritis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico San Matteo, SC Medicina Generale 1
Pavia, Pavia, 27100
Emanuela Miceli, MD, +390382503545, e.miceli@smatteo.pv.it
About this study
Autoimmune atrophic gastritis (AAG) is an immune-mediated disorder characterized by the loss of oxyntic glands and mucosal atrophy1.Specific autoantibodies directed to gastric parietal cells (PCA) and/or to intrinsic factors are inconstantly present1.Despite its morbidity, data on the epidemiology are scant. Its global prevalence has been estimated to be 0.5-4.5%.Hypo-achlorhydria and lack of intrinsic factor lead to malabsorption of many nutrients, as vit. B12, iron and calcium.A damage on elevated turnover cells may develop, affecting hemopoiesis, nervous system, gut, and myocardium, depicting a systemic disease.Moreover, one of the primary function of gastric acidity as a bactericidal defensive barrier is impaired resulting in both gastric and intestinal microbiota modification. It was recently shown that conditions causing hypo-achlorhydria modify the composition of microbiota from stomach to colon. In particular, at colonic level a decrease in the abundance of commensal bacteria associated to a reduction in microbial diversity and an increase of oral bacteria in the stool were shown.The clinical spectrum is unspecific, especially in early stages, leading to substantial diagnostic delay.Patients may be asymptomatic or complain of gastrointestinal manifestations such as atrophic glossitis, malabsorption, diarrhea, and dyspepsia.These symptoms are insufficient for the diagnosis.Neurological and psychiatric symptoms are often overlooked; myocardial infarction due to demand imbalance may occur.Most of AAG manifestations and complications are due to cyanocobalamin deficiency that may be clinically silent for years.Vit. B12 deficiency has also been associated with infertility, very early recurrent miscarriage, failure of assisted reproductive technologies, and neural tube defects.Furthermore, AAG is a preneoplastic condition as may predispose to the development of type I carcinoids and gastric adenocarcinoma.A previous publication of our group on the NH of AAG,showed that all patients evolved into a higher degree of gastric atrophy and/or metaplasia; additionally,6.3%of these patients developed a neoplastic complication (median time of 3 yo).These data underlined the need to feel the gap of knowledge in the identification and characterization of the factors promoting neoplastic development or associated with carcinogenesis.Moreover, strategies for prevention and management of non-neoplastic complications and extra-gastrointestinal manifestation have to be better determined Hence, a larger, prospective study looking at this issue is warranted.
- Conditions
- Atrophic Gastritis
- Medical subject headings
- Gastritis, Atrophic
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 |
|---|---|---|
| We enroll all atrophic gastritis diagnosis is made according to the updated Sydney System criteria | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clarify the natural history and the epidemiology of AAG in order to early diagnose patients, and to prevent irreversible complications
- The incidence of oncological gastric complications occurring in all autoimmune gastritis patients (potential, mild, moderate, severe)
- The correlates of oncological complications, including laboratory markers, family history, autoimmune comorbidities, clinical features, so to identify clinical clusters and cluster-specific correlate.
Measured: Baseline visit: all patients will be evaluated and all laboratory test required for protocol will be performed. 6 months, patients will be evaluated, for symptoms associated to AAG with VAS scale. 12 months a last evaluation will be performed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start17 Nov 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic GastritisStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emanuela Miceli, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388459
- Sponsor's protocol ID
- NH-GAA
- Acronym
- NH-GAA
- Status last verified
- Feb 2025
- First submitted
- 19 Mar 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History, Evolution, and Clinical Features of Autoimmune Atrophic Gastritis
- ClinicalTrials.gov ID
- NCT07388459
- Acronym / sponsor ID
- NH-GAA / NH-GAA
- Conditions
- Atrophic Gastritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Feb 2026 (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.
Autoimmune atrophic gastritis (AAG) is an immune-mediated disorder characterized by the loss of oxyntic glands and mucosal atrophy1.Specific autoantibodies directed to gastric parietal cells (PCA) and/or to intrinsic factors are inconstantly present1.Despite its morbidity, data on the epidemiology are scant. Its global prevalence has been estimated to be 0.5-4.5%.Hypo-achlorhydria and lack of intrinsic factor lead to malabsorption of many nutrients, as vit. B12, iron and calcium.A damage on elevated turnover cells may develop, affecting hemopoiesis, nervous system, gut, and myocardium, depicting a systemic disease.Moreover, one of the primary function of gastric acidity as a bactericidal defensive barrier is impaired resulting in both gastric and intestinal microbiota modification. It was recently shown that conditions causing hypo-achlorhydria modify the composition of microbiota from stomach to colon. In particular, at colonic level a decrease in the abundance of commensal bacteria associated to a reduction in microbial diversity and an increase of oral bacteria in the stool were shown.The clinical spectrum is unspecific, especially in early stages, leading to substantial diagnostic delay.Patients may be asymptomatic or complain of gastrointestinal manifestations such as atrophic glossitis, malabsorption, diarrhea, and dyspepsia.These symptoms are insufficient for the diagnosis.Neurological and psychiatric symptoms are often overlooked; myocardial infarction due to demand imbalance may occur.Most of AAG manifestations and complications are due to cyanocobalamin deficiency that may be clinically silent for years.Vit. B12 deficiency has also been associated with infertility, very early recurrent miscarriage, failure of assisted reproductive technologies, and neural tube defects.Furthermore, AAG is a preneoplastic condition as may predispose to the development of type I carcinoids and gastric adenocarcinoma.A previous publication of our group on the NH of AAG,showed that all patients evolved into a higher degree of gastric atrophy and/or metaplasia; additionally,6.3%of these patients developed a neoplastic complication (median time of 3 yo).These data underlined the need to feel the gap of knowledge in the identification and characterization of the factors promoting neoplastic development or associated with carcinogenesis.Moreover, strategies for prevention and management of non-neoplastic complications and extra-gastrointestinal manifestation have to be better determined Hence, a larger, prospective study looking at this issue is warranted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| We enroll all atrophic gastritis diagnosis is made according to the updated Sydney System criteria | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of both genders aged ≥ 18 years with atrophic gastritis being treated at Fondazione IRCCS Policlinico San Matteo
Key inclusion criteria (3 listed)
- Male or female, age ≥18 years;
- AAG diagnosis is made according to the updated Sydney System criteria referring to a tertiary outpatient clinic dedicated;
- Signed written informed consent.
Key exclusion criteria (3 listed)
- Patients with uncertain histopathological findings;
- Patients with persistent or active Helicobacter pylori infection;
- Patients with long-term proton pump inhibitor users and atrophic pangastritis
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
Clarify the natural history and the epidemiology of AAG in order to early diagnose patients, and to prevent irreversible complications
Time frame: Baseline visit: all patients will be evaluated and all laboratory test required for protocol will be performed. 6 months, patients will be evaluated, for symptoms associated to AAG with VAS scale. 12 months a last evaluation will be performed.
* The incidence of oncological gastric complications occurring in all autoimmune gastritis patients (potential, mild, moderate, severe) * The correlates of oncological complications, including laboratory markers, family history, autoimmune comorbidities, clinical features, so to identify clinical clusters and cluster-specific correlate.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- 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.
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 Atrophic Gastritis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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 3 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: looking for participants now, as of the sponsor's last update on 5 Feb 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emanuela Miceli, MD (+390382503545, e.miceli@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clarify the natural history and the epidemiology of AAG in order to early diagnose patients, and to prevent irreversible complications (time frame: Baseline visit: all patients will be evaluated and all laboratory test required for protocol will be performed. 6 months, patients will be evaluated, for symptoms associated to AAG with VAS scale. 12 months a last evaluation will be performed.). 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 5 Feb 2026.