NCT07388459 Natural History, Evolution, and Clinical Features of Autoimmune Atrophic Gastritis
| NCT ID | NCT07388459 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia |
| Condition | Atrophic Gastritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2023-11-17 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2023-11-17 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Patients with uncertain histopathological findings; * Patients with persistent or active Helicobacter pylori infection; * Patients with long-term proton pump inhibitor users and atrophic pangastritis
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07388459 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrophic Gastritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07388459 currently recruiting?
Yes, NCT07388459 is actively recruiting participants. Contact the research team at e.miceli@smatteo.pv.it for enrollment information.
Where is the NCT07388459 trial being conducted?
This trial is being conducted at Pavia, Italy.
Who is sponsoring the NCT07388459 clinical trial?
NCT07388459 is sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. The trial plans to enroll 600 participants.