Spirulina Platensis for PPI Withdrawal (SpAReDPPI)

Universidade de Passo Fundo

Status and phase: Completed; Phase 2

Conditions: Rebound Acid Hypersecretion; Dyspepsia; Gastro Esophageal Reflux Disease

Treatments: Other: Placebo comparator; Combination Product: Spirulina platensis

Study type: Interventional

Funder types: Other

Identifiers

NCT04988347

309/2010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 2 patient groups, including a placebo group

Spirulina

Experimental group

Description:

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

Treatment:

Combination Product: Spirulina platensis

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo comparator