Ignite Creation Date:
2024-05-06 @ 4:26 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04988347
Status:
COMPLETED
Last Update Posted:
2021-08-03
First Post:
2021-07-21
Brief Title:
Spirulina Platensis for PPI Withdrawal
Sponsor:
Universidade de Passo Fundo
Organization:
Universidade de Passo Fundo
Study Overview
Official Title:
The Effect of Spirulina Platensis on Rebound Dyspeptic Symptoms After Discontinuation of Proton Pump Inhibitors a Phase 2 Clinical Trial
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SpAReDPPI
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
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 mgday 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 16 gday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None