Gastric Acid Rebound Secretion Measured by Alkaline Tide

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 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: April 28, 2014
Last verified: April 2014
  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
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: 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.

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • prevention of acid rebound phenomenon after stoping PPI [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Comparing gradual and abrupt PPI cesation


Estimated Enrollment: 20
Study Start Date: December 2014
Estimated 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315444

Contacts
Contact: Yaron Niv, MD, FACG, AGAF 97238377237 nivyaron@013.net.il

Sponsors and Collaborators
Rabin Medical Center
  More Information

No publications provided

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
Study First Received: March 13, 2011
Last Updated: April 28, 2014
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014