Gastric Acid Rebound Secretion Measured by Alkaline Tide

Gradual Cessation of Proton Pump Inhibitor (PPI) Treatment May Prevent Rebound Acid Secretion in Dyspeptic and Reflux Patients, Measured by the Alkaline Tide Method.

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.

Study Overview

• Status: Withdrawn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

• Study Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PPI abrupt cessation; Abrupt cessation	Drug: Stop PPI gradually
Active Comparator: PPI gradual step down cessation; Gradual cessation	Drug: Stop PPI gradually

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevention of acid rebound phenomenon after stoping PPI	Comparing gradual and abrupt PPI cesation	30 days

Collaborators and Investigators

• Sponsor: Rabin Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: March 13, 2011
• First Submitted That Met QC Criteria: March 14, 2011
• First Posted (Estimate): March 15, 2011

Study Record Updates

• Last Update Posted (Actual): October 5, 2017
• Last Update Submitted That Met QC Criteria: October 3, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: AT 101; RMC 101 (Other Identifier: RMC 101)