Spirulina Platensis for PPI Withdrawal

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gastro Esophageal Reflux Disease, Dyspepsia, Rebound Acid Hypersecretion

Intervention / Treatment
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* Combination Product: Spirulina platensis
* Other: Placebo comparator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spirulina<br>Active treatment with Spirulina platensis in capsules containing 530 mg, 1 capsule orally each 8 hours, for 60 days | Combination Product: Spirulina platensis<br>* Active treatment with Spirulina platensis in capsules containing 530 mg, 1 capsule orally each 8 hours, for 60 days<br>|
| Placebo Comparator: Placebo<br>Placebo in capsules, 1 capsule orally each 8 hours, for 60 days | Other: Placebo comparator<br>* Placebo in capsules, 1 capsule orally each 8 hours, for 60 days<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with dyspeptic symptoms | Relapse of dyspeptic symptoms after PPIs cessation | 60 days | 
| Number of participants with typical GERD symptoms | Relapse of typical GERD symptoms | 60 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroesophageal reflux disease, Dyspepsia, Proton Pump Inhibitors, Spirulina platensis