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Spirulina Platensis for PPI Withdrawal (SpAReDPPI)

Primary Purpose

Gastro Esophageal Reflux Disease, Dyspepsia, Rebound Acid Hypersecretion

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Spirulina platensis
Placebo comparator
Sponsored by
Universidade de Passo Fundo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastro Esophageal Reflux Disease focused on measuring Gastroesophageal reflux disease, Dyspepsia, Proton Pump Inhibitors, Spirulina platensis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Spirulina

    Placebo

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Number of participants with dyspeptic symptoms
    Relapse of dyspeptic symptoms after PPIs cessation
    Number of participants with typical GERD symptoms
    Relapse of typical GERD symptoms

    Secondary Outcome Measures

    Rate of new endoscopic lesions
    Endoscopic lesions in the esophagus, stomach and duodenum, after PPIs cessation
    Number of participants with microscopic changes in the stomach
    number of participants with new or worsened gastric inflammation after PPIs cessation
    Number of participants with side effects
    Side effects potentially secondary to Spirulina platensis and placebo

    Full Information

    First Posted
    July 21, 2021
    Last Updated
    July 30, 2021
    Sponsor
    Universidade de Passo Fundo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04988347
    Brief Title
    Spirulina Platensis for PPI Withdrawal
    Acronym
    SpAReDPPI
    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

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2010 (Actual)
    Primary Completion Date
    February 2012 (Actual)
    Study Completion Date
    February 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade de Passo Fundo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastro Esophageal Reflux Disease, Dyspepsia, Rebound Acid Hypersecretion
    Keywords
    Gastroesophageal reflux disease, Dyspepsia, Proton Pump Inhibitors, Spirulina platensis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    ParticipantInvestigator
    Masking Description
    Capsules containing Spirulina and placebo were identical
    Allocation
    Randomized
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Spirulina
    Arm Type
    Experimental
    Arm Description
    Active treatment with Spirulina platensis in capsules containing 530 mg, 1 capsule orally each 8 hours, for 60 days
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo in capsules, 1 capsule orally each 8 hours, for 60 days
    Intervention Type
    Combination Product
    Intervention Name(s)
    Spirulina platensis
    Intervention Description
    Active treatment with Spirulina platensis in capsules containing 530 mg, 1 capsule orally each 8 hours, for 60 days
    Intervention Type
    Other
    Intervention Name(s)
    Placebo comparator
    Other Intervention Name(s)
    Placebo
    Intervention Description
    Placebo in capsules, 1 capsule orally each 8 hours, for 60 days
    Primary Outcome Measure Information:
    Title
    Number of participants with dyspeptic symptoms
    Description
    Relapse of dyspeptic symptoms after PPIs cessation
    Time Frame
    60 days
    Title
    Number of participants with typical GERD symptoms
    Description
    Relapse of typical GERD symptoms
    Time Frame
    60 days
    Secondary Outcome Measure Information:
    Title
    Rate of new endoscopic lesions
    Description
    Endoscopic lesions in the esophagus, stomach and duodenum, after PPIs cessation
    Time Frame
    60 days
    Title
    Number of participants with microscopic changes in the stomach
    Description
    number of participants with new or worsened gastric inflammation after PPIs cessation
    Time Frame
    60 days
    Title
    Number of participants with side effects
    Description
    Side effects potentially secondary to Spirulina platensis and placebo
    Time Frame
    60 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fernando Fornari, Professor
    Organizational Affiliation
    University of Passo Fundo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Spirulina Platensis for PPI Withdrawal

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