Gastric Acid Rebound Secretion Measured by Alkaline Tide

Phase 1

Withdrawn

• Conditions: Condition Measuring Alkaline Tide and Filling Symptoms' Questionnaire After Abrupt or Gradual Step Down Cessation of PPI
• Interventions: Drug: Stop PPI gradually

• Registration Number: NCT01315444
• Lead Sponsor: Rabin Medical Center

Brief Summary

Gastro esophageal reflux disease and ulcer related or non-ulcer dyspepsia, attacks 20% of the Western population. These millions of patients are treated continuously with PPI for different periods, many for many years. Recently, rebound acid hypersecretion was recognized as a major clinical event after cessation of PPI therapy. Sustained hypergastrinemia due to daily PPI therapy causes increased acid-secretory capacity that appears when the drug is stopped. The transient increase in blood and urinary pH following gastric secretion has been termed the alkaline tide phenomenon. Carbonic acid, formed in the presence of the enzyme carbonic anhydrase, neutralizes intracellular hydroxyl ions produced as a result of luminal acid secretion. The bicarbonate generated is removed from the cell via the baso-lateral chloride bicarbonate exchanger. The investigators have shown in several studies that this phenomenon parallels acid secretion. Thus, stimulation of acid secretion with test meal increased base excess maximally after 45 minutes and these changes parallel peak acid output measured in gastric aspirate. The investigators hypothesize that gradual step down cessation of PPI will prevent this clinical relevant event. By measuring alkaline tide after PPI cessation the investigators may prove this hypothesis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-13
• Study First Submitted QC: 2011-03-14
• Study First Posted: 2011-03-15
• Study Start: 2014-12
• Primary Completion: 2015-12
• Study Completion: 2016-12
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-03
• Last Update Posted: 2017-10-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Dyspepsia and reflux patients older than 18

Exclusion Criteria

• patients on PPI, patients with severe diseases, younger than 18 y, older than 80 y, un-cooperative, COPD, uncompensated IHD, CRF

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PPI abrupt cessation	Stop PPI gradually	Abrupt cessation
PPI gradual step down cessation	Stop PPI gradually	Gradual cessation

Primary Outcome Measures

Name	Time	Method
prevention of acid rebound phenomenon after stoping PPI	30 days	Comparing gradual and abrupt PPI cesation