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The Effect of Proton Pump Inhibitors on Transmucosal Esophageal Leak

Phase 1
18 Years
Not Enrolling
Reflux, Esophagitis, Barrett's Esophagus

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Trial Information

The Effect of Proton Pump Inhibitors on Transmucosal Esophageal Leak

In a related study, we have found evidence that patients with Barrett's esophagus have a
leak for oral sucrose to leave the lumen of their upper gastrointestinal tract, enter the
blood, and be filtered into urine. Normally the disaccharide sucrose cannot leave the lumen
of the gastrointestinal tract without being first hydrolyzed to glucose and fructose.
Appearance of the disaccharide in the bloodstream suggests a paracellular leak of some type
in the upper gastrointestinal tract. Once in the blood, sucrose is likewise not taken up or
metabolized by the kidney but simply filtered into the urine. The amount of sucrose
appearing in an overnight urine sample can be used to indicate the presence of Barrett's
esophagus and/or esophagitis in a patient reporting with reflux (GERD) symptoms. The leak
is presumably in the Barrett's epithelium itself. This phenomenon will be used to test if a
standard 8 week therapy of Nexium in a first-time-presenting GERD patient can reduce the
leak as a means of assessing the efficacy of the drug in that patient. We predict that
Nexium will reduce leak in esophagitis but not Barrett's patients.

In this study, patients over 18 years of age presenting with GERD symptoms to a primary care
physician, will be recruited after providing informed consent. Patients will perform a
sucrose leak test the evening after their recruitment by drinking a solution of 100 gms of
sucrose in 200 cc of water at bedtime, then collecting an overnight urine sample (8 hrs).
Within 5 days the patient will undergo an upper endoscopy exam. The patient will then begin
Nexium therapy (40 mg/day of Esomeprazole) for 8 weeks, taking the dose each morning before
breakfast. After 8 weeks the patient will undergo a second sucrose leak test as described
above. Urine sucrose will be determined by HPLC.

Inclusion Criteria:

Patients presenting to a general practitioner / internist with symptoms of GERD defined

- Heartburn - uncomfortable, rising, burning sensation behind the breastbone

- Regurgitation of gastric acid or sour contents into the mouth

- Chest pain atypical for cardiac ischemia and more suggestive of GERD

- Symptoms for more than three weeks with no concurrent use of PPI's or H-2 blockers
during that time period

- A score greater than or equal to 5 on the AstraZeneca RDQ

Exclusion Criteria:

- Any patients presenting with alarm symptoms (GI bleeding, dysphagia, weight loss,
abdominal mass, lymphadenopathy, or recurrent vomiting)

- Diabetes (type I or II)

- Renal insufficiency defined as creatinine >1.6

- Under 18 years of age

- Prior surgery on esophagus, stomach or duodenum

- History of gastric/duodenal ulcers

- History of H. pylori

- Known history of Barrett's esophagus (recruited to parallel study)

- On Coumadin or Heparin therapy

- Chronic upper abdominal pain more consistent with dyspepsia or other diagnoses

- Noncompliant patients

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Urine sucrose level falls below 90 mg after 8 weeks of therapy

Principal Investigator

James M Mullin, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Main Line Health


United States: Institutional Review Board

Study ID:




Start Date:

January 2006

Completion Date:

January 2006

Related Keywords:

  • Reflux
  • Esophagitis
  • Barrett's Esophagus
  • Sucrose
  • Barrett's esophagus
  • Esophagitis
  • GERD
  • Reflux
  • Esophagus
  • Esomeprazole
  • Barrett Esophagus
  • Esophagitis



Lankenau Hospital Wynnewood, Pennsylvania  19096