Spirulina Platensis for PPI Withdrawal (SpAReDPPI)

July 30, 2021 updated by: Fernando Fornari, Universidade de Passo Fundo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Spirulina
Active treatment with Spirulina platensis in capsules containing 530 mg, 1 capsule orally each 8 hours, for 60 days
Combination product: Spirulina platensis
Active treatment with Spirulina platensis in capsules containing 530 mg, 1 capsule orally each 8 hours, for 60 days
PLACEBO_COMPARATOR: Placebo
Placebo in capsules, 1 capsule orally each 8 hours, for 60 days
Other: Placebo comparator
Placebo in capsules, 1 capsule orally each 8 hours, for 60 days
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with dyspeptic symptoms
Time Frame: 60 days
Relapse of dyspeptic symptoms after PPIs cessation
60 days
Number of participants with typical GERD symptoms
Time Frame: 60 days
Relapse of typical GERD symptoms
60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of new endoscopic lesions
Time Frame: 60 days
Endoscopic lesions in the esophagus, stomach and duodenum, after PPIs cessation
60 days
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
60 days
Number of participants with side effects
Time Frame: 60 days
Side effects potentially secondary to Spirulina platensis and placebo
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade de Passo Fundo

Investigators

  • Principal Investigator: Fernando Fornari, Professor, University of Passo Fundo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2010

Primary Completion (ACTUAL)

February 1, 2012

Study Completion (ACTUAL)

February 1, 2012

Study Registration Dates

First Submitted

July 21, 2021

First Submitted That Met QC Criteria

July 30, 2021

First Posted (ACTUAL)

August 3, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2021

Last Update Submitted That Met QC Criteria

July 30, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 309/2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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