Spirulina platensis
Combination ProductActive treatment with Spirulina platensis in capsules containing 530 mg, 1 capsule orally each 8 hours, for 60 days
NCT Number: NCT04988347
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.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 2
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Active treatment with Spirulina platensis in capsules containing 530 mg, 1 capsule orally each 8 hours, for 60 days
Placebo in capsules, 1 capsule orally each 8 hours, for 60 days
Other names: Placebo
Time frame: 60 days
Relapse of dyspeptic symptoms after PPIs cessation
Time frame: 60 days
Relapse of typical GERD symptoms
Time frame: 60 days
Endoscopic lesions in the esophagus, stomach and duodenum, after PPIs cessation
Time frame: 60 days
number of participants with new or worsened gastric inflammation after PPIs cessation
Time frame: 60 days
Side effects potentially secondary to Spirulina platensis and placebo
Universidade de Passo Fundo
Other
The Effect of Spirulina Platensis on Rebound Dyspeptic Symptoms After Discontinuation of Proton Pump Inhibitors: a Phase 2 Clinical Trial
Acronym: SpAReDPPI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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