Spirulina Platensis for PPI Withdrawal

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effectiveness of the Eradication of Helicobacter Pylori and an Inhibitor of Pump With Proton Versus Control

NCT00713947

Positive Helicobacter Pylori Serology Coronary Thrombosis Supra-aortic Artery Thrombosis

WITHDRAWN PHASE4

PROGRESSive Withdrawal Esomeprazole and Acid-related Symptoms

NCT02476097

Stomach Diseases

UNKNOWN PHASE4

The Clinical Significance of Acid Rebound in Functional Dyspepsia

NCT01373970

Functional Dyspepsia

TERMINATED PHASE4

Strategies for Improving Proton Pump Inhibitors (PPIs) Prescription Associated to Non-steroidal Anti-inflammatory Drugs (NSAIDs)

NCT01128127

Adverse Events

WITHDRAWN NA

Efficacy and Safety of Jianpi Qinghua Granules in Patients With Nonerosive Reflux Disease

NCT04324138

Nonerosive Reflux Disease

UNKNOWN EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastro Esophageal Reflux Disease Dyspepsia Rebound Acid Hypersecretion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Capsules containing Spirulina and placebo were identical

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Spirulina

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

Group Type EXPERIMENTAL

Spirulina platensis

Intervention Type COMBINATION_PRODUCT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo comparator

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.