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Gastric Acid Rebound Secretion Measured by Alkaline Tide

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01315444
First Posted: March 15, 2011
Last Update Posted: October 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yaron Niv, Tel Aviv University
  Purpose
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 Intervention Phase
Condition Measuring Alkaline Tide and Filling Symptoms' Questionnaire After Abrupt or Gradual Step Down Cessation of PPI Drug: Stop PPI gradually Phase 1

Study Type: Interventional
Study Design: 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.

Further study details as provided by Yaron Niv, Tel Aviv University:

Primary Outcome Measures:
  • prevention of acid rebound phenomenon after stoping PPI [ Time Frame: 30 days ]
    Comparing gradual and abrupt PPI cesation


Enrollment: 0
Study Start Date: December 2014
Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PPI abrupt cessation
Abrupt cessation
Drug: Stop PPI gradually
Active Comparator: PPI gradual step down cessation
Gradual cessation
Drug: Stop PPI gradually

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
No Contacts or Locations Provided
  More Information

Responsible Party: Yaron Niv, Director, Department of Gastroenterology, Tel Aviv University
ClinicalTrials.gov Identifier: NCT01315444     History of Changes
Other Study ID Numbers: AT 101
RMC 101 ( Other Identifier: RMC 101 )
First Submitted: March 13, 2011
First Posted: March 15, 2011
Last Update Posted: October 5, 2017
Last Verified: October 2017