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Pilot Study of Helicobacter Pylori and Ocular Surface Disease

Not Enrolling
Helicobacter Infections

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Trial Information

Pilot Study of Helicobacter Pylori and Ocular Surface Disease

Helicobacter pylori, one of the world's most prevalent pathogens, is a spiral-shaped,
catalase-positive, Gram-negative rod with 4-6 sheathed flagella attached to one pole which
allow for motility. The prevalence of H. pylori infection in humans is high; 50% of those
over the age of 60 are infected. H. pylori infection causes chronic gastric inflammation,
ulcer disease and gastric carcinoma. Further, chronic antigenic stimulation driven by H.
pylori infection has been linked to the development of gastric mucosa associated lymphoid
tissue (MALT) lymphoma. Infection with H. pylori induces a vigorous immune response
resulting in the presence of local and systemic antibodies. H. pylori-specific
immunoglobulin G antibodies present in serum, plasma, whole blood, saliva, gastric juice and
urine have each been used to successfully detect the presence of infection in adults. The
sensitivity and specificity of serological tests range from 80% to 95% depending upon the
assay used. H. Pylori infection is characteristically associated with a vigorous
inflammatory response and we have recently identified H. Pylori DNA in conjunctival MALT
lymphoma using molecular diagnostic techniques. Ocular surface inflammation is a cardinal
feature of keratoconjunctivitis sicca. Since we identified H. Pylori DNA in conjunctival
MALT lymphoma we hypothesize that chronic infection may also be capable of triggering
chronic ocular surface inflammation as seen in keratoconjunctivitis sicca. The purpose of
this pilot study is to determine whether H. pylori DNA is detectable in the conjunctiva of
seropositive KCS patients.

Inclusion Criteria


Patients with ocular surface disease including aqueous or evaporative tear deficiency who
are seropositive for H. pylori will be eligible. Controls will be adults without ocular
surface disease who are seropositve for H. pylori.


None listed.

Type of Study:


Study Design:



United States: Federal Government

Study ID:




Start Date:

May 2004

Completion Date:

March 2005

Related Keywords:

  • Helicobacter Infections
  • Dry Eyes
  • Conjunctiva
  • Infection
  • Antibodies
  • Inflammation
  • Ocular Surface Disease
  • Helicobacter Pylori
  • Helicobacter Infections



National Eye Institute (NEI) Bethesda, Maryland  20892