Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-31 @ 6:49 PM
Study NCT ID:
NCT06808867
Status:
COMPLETED
Last Update Posted:
2025-02-05
First Post:
2025-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Dietary Supplement in Subjects With Acid Reflux and/or Abdominal Bloating/Distention and GI Symptoms
Sponsor:
Olly, PBC
Organization:
Study Overview
Official Title:
A 6-week Randomized, Double-blind, Comparative Clinical Study of the Efficacy of an Oral Product in Subjects With Acid Reflux and/or Abdominal Bloating/Distention and Gastrointestinal Symptoms
Status:
COMPLETED
Status Verified Date:
2025-01
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:
None
Brief Summary:
This study was a prospective randomized clinical study. There was interventional treatment for a total of 8 weeks including a 2-week washout period. The subjects attended four appointments in the clinic throughout the duration of the study.
Study Primary Objective:
• To assess improvement in bloating symptoms
Study Secondary Objectives:
* To assess safety and tolerability of the formulation
* To compare the time taken for perceptual improvement in bloating/distention
* Enzyme blood assays
* To assess quality of life indices
Study Primary Objective:
• To assess improvement in bloating symptoms
Study Secondary Objectives:
* To assess safety and tolerability of the formulation
* To compare the time taken for perceptual improvement in bloating/distention
* Enzyme blood assays
* To assess quality of life indices
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: