Spirulina Platensis for PPI Withdrawal

NCT04988347 | Completed Phase 2

• 1 other identifier: 309/2010
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastro Esophageal Reflux Disease; Dyspepsia; Rebound Acid Hypersecretion

Keywords

Gastroesophageal reflux disease; Dyspepsia; Proton Pump Inhibitors; Spirulina platensis

Outcome Measures

Primary Outcomes (2)

• Number of participants with dyspeptic symptoms

  Relapse of dyspeptic symptoms after PPIs cessation

  60 days

• Number of participants with typical GERD symptoms

  Relapse of typical GERD symptoms

  60 days

Secondary Outcomes (3)

• Rate of new endoscopic lesions

  60 days

• Number of participants with microscopic changes in the stomach

  60 days

• Number of participants with side effects

  60 days

Study Arms (2)

Spirulina

EXPERIMENTAL

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

Combination Product: Spirulina platensis

Placebo

PLACEBO COMPARATOR

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

Other: Placebo comparator

Interventions

Spirulina platensis COMBINATION_PRODUCT

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

Spirulina

Placebo comparator OTHER

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

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Uncompensated acute and chronic morbidities
• Gastroesophageal surgery
• Cognitive deficit

Sponsors & Collaborators

• Universidade de Passo Fundo: lead

Related Publications (1)

• Gronevalt ATM, Bertolin TE, Forcelini CM, Polletto PHM, Pasetti BW, Graeff DB, Rodriguez R, Fornari F. Spirulina Platensis Attenuates Rebound Dyspeptic Symptoms After Proton Pump Inhibitors' Discontinuation: Phase 2 Placebo-controlled Trial. Altern Ther Health Med. 2024 Feb;30(2):18-24.

  PMID: 38401078 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux; Dyspepsia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fernando Fornari, Professor

  University of Passo Fundo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Capsules containing Spirulina and placebo were identical
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: August 3, 2021
• Study Start: November 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: August 3, 2021

Record last verified: 2021-07