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OpenTrials
Completed

NCT Number: NCT04988347

Spirulina Platensis for PPI Withdrawal

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.

Completed

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spirulina platensis

Combination Product

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

Placebo Comparator

Other

Placebo in capsules, 1 capsule orally each 8 hours, for 60 days

Other names: Placebo

Primary outcomes

  1. Number of participants with dyspeptic symptoms

    Time frame: 60 days

    Relapse of dyspeptic symptoms after PPIs cessation

  2. Number of participants with typical GERD symptoms

    Time frame: 60 days

    Relapse of typical GERD symptoms

Secondary outcomes

  1. Rate of new endoscopic lesions

    Time frame: 60 days

    Endoscopic lesions in the esophagus, stomach and duodenum, after PPIs cessation

  2. Number of participants with microscopic changes in the stomach

    Time frame: 60 days

    number of participants with new or worsened gastric inflammation after PPIs cessation

  3. Number of participants with side effects

    Time frame: 60 days

    Side effects potentially secondary to Spirulina platensis and placebo

Sponsors and collaborators

Lead sponsor

Universidade de Passo Fundo

Other

Registry information

Official study title

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

Acronym: SpAReDPPI

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 3, 2021
Registry last updated
Aug 3, 2021

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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