Gastro Esophageal Reflux DiseasePhase 2SpAReDPPINCT04988347
Spirulina Platensis for PPI Withdrawal
A Phase 2 study testing Spirulina platensis in people with Gastro Esophageal Reflux Disease and Dyspepsia, run by Universidade de Passo Fundo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastro Esophageal Reflux Disease, Dyspepsia, Rebound Acid Hypersecretion
- What is being tested?
- Spirulina platensis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Feb 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Uncompensated acute and chronic morbidities
- Gastroesophageal surgery
- Cognitive deficit
About this study
Official title: 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.
Read the 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.
- Being tested
- Spirulina platensis, Placebo comparator
- Keywords
- Gastroesophageal reflux disease, Dyspepsia, Proton Pump Inhibitors, Spirulina platensis
- Medical subject headings
- Gastroesophageal Reflux, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spirulina platensisCombination product
Active treatment with Spirulina platensis in capsules containing 530 mg, 1 capsule orally each 8 hours, for 60 days
Placebo comparatorOther
Also called Placebo
Placebo in capsules, 1 capsule orally each 8 hours, for 60 days
| Study group | Role | What they receive |
|---|---|---|
| Spirulina | Experimental | Active treatment with Spirulina platensis in capsules containing 530 mg, 1 capsule orally each 8 hours, for 60 days Receives: Combination Product: Spirulina platensis |
| Placebo | Placebo comparator | Placebo in capsules, 1 capsule orally each 8 hours, for 60 days Receives: Other: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dyspeptic symptoms
Relapse of dyspeptic symptoms after PPIs cessation
Measured: 60 days
Number of participants with typical GERD symptoms
Relapse of typical GERD symptoms
Measured: 60 days
Secondary outcomes (3)
Rate of new endoscopic lesions
Endoscopic lesions in the esophagus, stomach and duodenum, after PPIs cessation
Measured: 60 days
Number of participants with microscopic changes in the stomach
number of participants with new or worsened gastric inflammation after PPIs cessation
Measured: 60 days
Number of participants with side effects
Side effects potentially secondary to Spirulina platensis and placebo
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study startNov 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastro Esophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade de Passo Fundo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Fornari, Universidade de Passo Fundo
- Investigators
- Fernando Fornari, Professor, Principal investigator, University of Passo Fundo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988347
- Sponsor's protocol ID
- 309/2010
- Acronym
- SpAReDPPI
- Status last verified
- Jul 2021
- First submitted
- 21 Jul 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38401078
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Spirulina Platensis on Rebound Dyspeptic Symptoms After Discontinuation of Proton Pump Inhibitors: a Phase 2 Clinical Trial
- ClinicalTrials.gov ID
- NCT04988347
- Acronym / sponsor ID
- SpAReDPPI / 309/2010
- Keywords
- Gastroesophageal reflux disease, Dyspepsia, Proton Pump Inhibitors, Spirulina platensis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Universidade de Passo FundoUniversity, hospital or other
- Study start
- Nov 2010 (actual)
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Spirulina | Experimental | Combination Product: Spirulina platensisActive treatment with Spirulina platensis in capsules containing 530 mg, 1 capsule orally each 8 hours, for 60 days |
| Placebo | Placebo comparator | Other: Placebo comparatorPlacebo in capsules, 1 capsule orally each 8 hours, for 60 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Uncompensated acute and chronic morbidities
- Gastroesophageal surgery
- Cognitive deficit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spirulina platensisActive treatment with Spirulina platensis in capsules containing 530 mg, 1 capsule orally each 8 hours, for 60 days | Combination product | Spirulina |
| Placebo comparatorAlso: PlaceboPlacebo in capsules, 1 capsule orally each 8 hours, for 60 days | Other | Placebo |
Primary outcome
Number of participants with dyspeptic symptoms
Time frame: 60 days
Relapse of dyspeptic symptoms after PPIs cessation
Number of participants with typical GERD symptoms
Time frame: 60 days
Relapse of typical GERD symptoms
3 secondary outcomes
Rate of new endoscopic lesions
Time frame: 60 days
Number of participants with microscopic changes in the stomach
Time frame: 60 days
Number of participants with side effects
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Derived from this study: PubMed 38401078Gronevalt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Fornari, Professor principal investigator
University of Passo Fundo
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Spirulina platensis in people with Gastro Esophageal Reflux Disease and Dyspepsia, run by Universidade de Passo Fundo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with dyspeptic symptoms (time frame: 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04988347, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.