Gastric Acid Rebound Secretion Measured by Alkaline Tide

Sponsor

Rabin Medical Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01315444

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Condition Measuring Alkaline Tide and Filling Symptoms' Questionnaire After Abrupt or Gradual Step Down Cessation of PPI	Drug: Stop PPI gradually Drug: Stop PPI gradually	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Dec 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

prevention of acid rebound phenomenon after stoping PPI [30 days]
Comparing gradual and abrupt PPI cesation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Rabin Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yaron Niv, Director, Department of Gastroenterology, Tel Aviv University

ClinicalTrials.gov Identifier:

NCT01315444

Other Study ID Numbers:

AT 101
RMC 101

First Posted:

Mar 15, 2011

Last Update Posted:

Oct 5, 2017

Last Verified:

Oct 1, 2017

Study Results

No Results Posted as of Oct 5, 2017