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Clinical Trials/NCT01315444
NCT01315444WithdrawnPhase 1

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

Rabin Medical Center0 sitesStarted: December 2014Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Withdrawn
Primary Endpoint
prevention of acid rebound phenomenon after stoping PPI

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

PPI abrupt cessation

Active Comparator

Abrupt cessation

Intervention: Stop PPI gradually (Drug)

PPI gradual step down cessation

Active Comparator

Gradual cessation

Intervention: Stop PPI gradually (Drug)

Outcomes

Primary Outcomes

prevention of acid rebound phenomenon after stoping PPI

Time Frame: 30 days

Comparing gradual and abrupt PPI cesation

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yaron Niv

Director, Department of Gastroenterology

Tel Aviv University

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