NCT04988347

Spirulina Platensis for PPI Withdrawal

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Universidade de Passo Fundo · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Gastro Esophageal Reflux Disease
• Dyspepsia
• Rebound Acid Hypersecretion

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Spirulina platensis	Active treatment with Spirulina platensis in capsules containing 530 mg, 1 capsule orally each 8 hours, for 60 days
OTHER	Placebo comparator	Placebo in capsules, 1 capsule orally each 8 hours, for 60 days

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2021-08-03
• Last updated: 2021-08-03