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Gastric Acid Rebound Secretion Measured by Alkaline Tide

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Clalit Health Services

Status and phase

Withdrawn
Phase 1

Conditions

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

Treatments

Drug: Stop PPI gradually

Study type

Interventional

Funder types

Other

Identifiers

NCT01315444
AT 101
RMC 101 (Other Identifier)

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 2 patient groups

PPI abrupt cessation
Active Comparator group
Description:
Abrupt cessation
Treatment:
Drug: Stop PPI gradually
Drug: Stop PPI gradually
PPI gradual step down cessation
Active Comparator group
Description:
Gradual cessation
Treatment:
Drug: Stop PPI gradually
Drug: Stop PPI gradually

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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