Spirulina Platensis for PPI Withdrawal

Dyspepsia Clinical Trial

— SpAReDPPI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04988347
• Other study ID #: 309/2010
• Status: Completed
• Phase: Phase 2
• Start date: November 2010
• Est. completion date: February 2012

Study information

• Verified date: July 2021
• Source: Universidade de Passo Fundo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyspepsia
• Gastro Esophageal Reflux Disease
• Gastroesophageal Reflux

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade de Passo Fundo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with dyspeptic symptoms	Relapse of dyspeptic symptoms after PPIs cessation	60 days
Primary	Number of participants with typical GERD symptoms	Relapse of typical GERD symptoms	60 days
Secondary	Rate of new endoscopic lesions	Endoscopic lesions in the esophagus, stomach and duodenum, after PPIs cessation	60 days
Secondary	Number of participants with microscopic changes in the stomach	number of participants with new or worsened gastric inflammation after PPIs cessation	60 days
Secondary	Number of participants with side effects	Side effects potentially secondary to Spirulina platensis and placebo	60 days