SpAReDPPI: Spirulina Platensis for PPI Withdrawal

Sponsor

Universidade de Passo Fundo (Other)

Overall Status

Completed

CT.gov ID

NCT04988347

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastro Esophageal Reflux Disease Dyspepsia Rebound Acid Hypersecretion	Combination Product: Spirulina platensis Other: Placebo comparator	Phase 2

Detailed Description

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant, Investigator)

Masking Description:

Capsules containing Spirulina and placebo were identical

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Feb 1, 2012

Actual Study Completion Date :

Feb 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Number of participants with dyspeptic symptoms [60 days]
Relapse of dyspeptic symptoms after PPIs cessation
Number of participants with typical GERD symptoms [60 days]
Relapse of typical GERD symptoms

Secondary Outcome Measures

Rate of new endoscopic lesions [60 days]
Endoscopic lesions in the esophagus, stomach and duodenum, after PPIs cessation
Number of participants with microscopic changes in the stomach [60 days]
number of participants with new or worsened gastric inflammation after PPIs cessation
Number of participants with side effects [60 days]
Side effects potentially secondary to Spirulina platensis and placebo

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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