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Gastric Acid Rebound Secretion Measured by Alkaline Tide

NCT ID: NCT01315444

Last Updated: 2017-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-12-31

Brief Summary

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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

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Conditions

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Condition Measuring Alkaline Tide and Filling Symptoms' Questionnaire After Abrupt or Gradual Step Down Cessation of PPI

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PPI abrupt cessation

Abrupt cessation

Group Type ACTIVE_COMPARATOR

Stop PPI gradually

Intervention Type DRUG

PPI gradual step down cessation

Gradual cessation

Group Type ACTIVE_COMPARATOR

Stop PPI gradually

Intervention Type DRUG

Interventions

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Stop PPI gradually

Intervention Type DRUG

Stop PPI gradually

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Yaron Niv

Director, Department of Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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RMC 101

Identifier Type: OTHER

Identifier Source: secondary_id

AT 101

Identifier Type: -

Identifier Source: org_study_id