Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2025-12-31 @ 7:03 AM
Study NCT ID:
NCT03964103
Status:
COMPLETED
Last Update Posted:
2019-06-04
First Post:
2019-05-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
qQ-lab Daily-IBS for Irritable Bowel Syndrome
Sponsor:
IlDong Pharmaceutical Co Ltd
Organization:
Study Overview
Official Title:
Efficacy and Colon Attachment of gQ-lab Daily for Patients With Irritable Bowel Syndrome: Randomized, Double-blind, Placebo-controlled, Parallel-group Study
Status:
COMPLETED
Status Verified Date:
2019-05
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:
* Primary purpose: To assess satisfaction with overall improvement in symptoms, including individual bowel symptoms, after 4 weeks of administration of gQ-lab to patients with irritable bowel syndrome (IBS).
* Secondary purposes: To assess the correlation between intestinal attachment and therapeutic effects of gQ-lab through the visual analog scale (VAS) assessment of each IBS-related symptom and measurement of changes in quality of life and fecal flora in the placebo group and gQ-lab group after 4 weeks of gQ-lab administration.
To assess safety, including adverse reactions, vital signs (including weight), physical examination, and changes in blood test results.
To examine the rate of positive gut quotient (gQ) values in patients diagnosed with IBS as per the ROME III criteria. Further, to examine how the ROME III-based symptom scale score compared with that of the quality of life scale in the gQ questionnaire.
* Secondary purposes: To assess the correlation between intestinal attachment and therapeutic effects of gQ-lab through the visual analog scale (VAS) assessment of each IBS-related symptom and measurement of changes in quality of life and fecal flora in the placebo group and gQ-lab group after 4 weeks of gQ-lab administration.
To assess safety, including adverse reactions, vital signs (including weight), physical examination, and changes in blood test results.
To examine the rate of positive gut quotient (gQ) values in patients diagnosed with IBS as per the ROME III criteria. Further, to examine how the ROME III-based symptom scale score compared with that of the quality of life scale in the gQ questionnaire.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: