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Spirulina Platensis for PPI Withdrawal — SpAReDPPI  

Dyspepsia Clinical Trial

Official title:
The Effect of Spirulina Platensis on Rebound Dyspeptic Symptoms After Discontinuation of Proton Pump Inhibitors: a Phase 2 Clinical Trial

Clinical Trial Summary

Background: Rebound acid hypersecretion after proton pump inhibitors (PPIs) discontinuation may be accompanied by dyspepsia. Aim: To assess whether Spirulina platensis, by its anti-inflammatory properties, could minimize rebound symptoms after PPIs withdrawal.

Clinical Trial Description

Forty-five regular users of PPIs entered in a 28-day run-in phase of pantoprazole 40 mg/day, followed by clinical and endoscopic evaluation. In the absence of large hiatal hernia, peptic ulcer, or moderate to severe reflux esophagitis, patients stopped PPIs and were randomly assigned to receive Spirulina (1.6 g/day) or placebo for 2 months, when evaluation was repeated. Primary outcomes were dyspepsia and typical reflux symptoms (either appearance or maintenance of symptoms > 50% from baseline). Intention-to-treat analysis was applied. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04988347
Study type Interventional
Source Universidade de Passo Fundo
Contact
Status Completed
Phase Phase 2
Start date November 2010
Completion date February 2012
View Details
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