Clinical trial NCT04988347: Spirulina Platensis for PPI Withdrawal
Official title: The Effect of Spirulina Platensis on Rebound Dyspeptic Symptoms After Discontinuation of Proton Pump Inhibitors: a Phase 2 Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastro Esophageal Reflux Disease
Dyspepsia
Rebound Acid Hypersecretion
Keywords: Gastroesophageal reflux disease
Dyspepsia
Proton Pump Inhibitors
Spirulina platensis
Lead sponsor: Universidade de Passo Fundo
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with dyspeptic symptoms
timeFrame: 60 days
measure: Number of participants with typical GERD symptoms
timeFrame: 60 days
Secondary outcomes:
measure: Rate of new endoscopic lesions
timeFrame: 60 days
measure: Number of participants with microscopic changes in the stomach
timeFrame: 60 days
measure: Number of participants with side effects
timeFrame: 60 days
Other outcomes:
Locations:
Study officials:
affiliation: University of Passo Fundo
name: Fernando Fornari, Professor
role: PRINCIPAL_INVESTIGATOR
References: