Helicobacter Pylori determination in a Fecal Immunochemical Test (FIT) - a proof of concept -

Helicobacter pylori (H. pylori) is recognised as a worldwide problem. Asian
countries are considered as high risk areas since the majority of the
population is still infected with prevalence rates up to 80%. In low risk areas
such as the Netherlands prevalence rate is decreasing and is stated around 30%.
Risk factors for the acquisition of a H. pylori infection are low socioeconomic
status, crowded living conditions and a lack of hot tap water. H. pylori is
considered as the starting point of a sequence of several gastric conditions.
This sequence leads from H. pylori infection to atrophic gastritis, intestinal
metaplasia and dysplasia of the gastric mucosa and eventually ends in
intestinal-type gastric adenocarcinoma in 1-2% of the infected patients. Over
80% of the patients with gastric cancer are infected by H. pylori. Usually, H.
pylori infections do not resolve without eradication treatment (consisting of a
combination of antibiotics and proton pump inhibitors). In current practice, it
is recommended to eradicate this infection when identified. Indeed, some
studies even state to actively screen-and-treat patients with investigated
dyspepsia.
The Consensus Group of the Asia-Pacific Consensus Guideline concluded a
screen-and-treat method for H. pylori is a reasonable strategy in communities
where the burden of gastric cancer is high. Although, they state major
logistical issues need to be addressed for such a strategy to be widely
adopted.There are several noninvasive tests available for the diagnosis of H.
pylori infection, of which a stool antigen test (SAT) seems most suitable. This
test could indicate an ongoing H. pylori infection and it is easy to perform.
However, it is still on debate what type of stool sample is most eligible for
the detection of H. pylori infections. Worldwide, screening programs for
colorectal cancer (CRC) are already being implemented mostly by using fecal
immunochemical tests (FIT). Eligibility of FIT for the diagnosis of H. pylori
infection could lead to dual screening of the upper and lower gastrointestinal
tract by using the same stool sample and overcome logistic barriers.

To evaluate the accuracy of H. pylori determination in FIT

prospective, proof of concept study

No extra site visits are needed for this study. Patients are contacted by
telephone one week prior to H. pylori testing. When willingness to participate,
stool samples will be sent together with PIF/IC. On the day of the already
planned UBT, stool samples will be collected and one blood sample will be
drawn. Confirmation of eradication with repeated UBT is regular standard of
care and will take place 4-6 weeks after antibiotic therapy. For study
purposes, another 2 feces samples are asked to be collected. Burden and risks
associated with participation is expected to be very low.
Gastroenterology staff will undergo the above mentioned tests because of their
possible increased risk of having an H. pylori infection. As described, risks
of undergoing these test are low. Participation in this study will provide
insights in current H. pylori status for which treatment can be given in case
of a positive test.