Spirulina Platensis for PPI Withdrawal

Phase 2

Completed

• Conditions: Gastro Esophageal Reflux Disease; Dyspepsia; Rebound Acid Hypersecretion
• Interventions: Other: Placebo comparator; Combination Product: Spirulina platensis

• Registration Number: NCT04988347
• Lead Sponsor: Universidade de Passo Fundo

Brief 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.

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2021-07
• Study First Submitted: 2021-07-21
• Study First Submitted QC: 2021-07-30
• Last Update Submitted: 2021-07-30
• Study First Posted: 2021-08-03
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Chronic use of any PPIs, either original brand or generic
• Absence of conditions that contraindicate the cessation of PPIs, such as active or recent peptic ulcer, active or recent upper digestive bleeding, regular use of salicylates or non-steroidal anti-inflammatory drugs, moderate to severe reflux esophagitis, and sliding hiatal hernia greater than 3 cm
• Formal agreement to participate

Exclusion Criteria

• Uncompensated acute and chronic morbidities
• Gastroesophageal surgery
• Cognitive deficit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo comparator	Placebo in capsules, 1 capsule orally each 8 hours, for 60 days
Spirulina	Spirulina platensis	Active treatment with Spirulina platensis in capsules containing 530 mg, 1 capsule orally each 8 hours, for 60 days

Primary Outcome Measures

Name	Time	Method
Number of participants with dyspeptic symptoms	60 days	Relapse of dyspeptic symptoms after PPIs cessation
Number of participants with typical GERD symptoms	60 days	Relapse of typical GERD symptoms

Secondary Outcome Measures

Name	Time	Method
Rate of new endoscopic lesions	60 days	Endoscopic lesions in the esophagus, stomach and duodenum, after PPIs cessation
Number of participants with microscopic changes in the stomach	60 days	number of participants with new or worsened gastric inflammation after PPIs cessation
Number of participants with side effects	60 days	Side effects potentially secondary to Spirulina platensis and placebo