Text Size

Gastric Acid Rebound Secretion Measured by Alkaline Tide

This study is not yet open for participant recruitment.
Verified December 2012 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
Yaron Niv, Tel Aviv University
ClinicalTrials.gov Identifier:
NCT01315444
First received: March 13, 2011
Last updated: December 2, 2012
Last verified: December 2012
History of Changes

March 13, 2011
December 2, 2012
May 2013
May 2015   (final data collection date for primary outcome measure)
prevention of acid rebound phenomenon after stoping PPI [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Comparing gradual and abrupt PPI cesation
Not Provided
Complete list of historical versions of study NCT01315444 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Measuring Alkaline Tide and Filling Symptoms' Questionnaire After Abrupt or Gradual Step Down Cessation of PPI.
Drug: Stop PPI gradually
  • Active Comparator: PPI abrupt cessation
    Abrupt cessation
    Intervention: Drug: Stop PPI gradually
  • Active Comparator: PPI gradual step down cessation
    Gradual cessation
    Intervention: Drug: Stop PPI gradually
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
Not Provided
May 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Yaron Niv, MD, FACG, AGAF 97238377237 nivyaron@013.net.il
Not Provided
 
NCT01315444
AT 101, RMC 101
No
Yaron Niv, Tel Aviv University
Rabin Medical Center
Not Provided
Not Provided
Rabin Medical Center
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP