Trials / Completed
CompletedNCT03964103
qQ-lab Daily-IBS for Irritable Bowel Syndrome
Efficacy and Colon Attachment of gQ-lab Daily for Patients With Irritable Bowel Syndrome: Randomized, Double-blind, Placebo-controlled, Parallel-group Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- IlDong Pharmaceutical Co Ltd · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | gQ-lab daily | probiotics |
| DIETARY_SUPPLEMENT | Placebo | powdered skim milk, lactose |
Timeline
- Start date
- 2016-10-04
- Primary completion
- 2017-11-08
- Completion
- 2018-01-22
- First posted
- 2019-05-28
- Last updated
- 2019-06-04
Source: ClinicalTrials.gov record NCT03964103. Inclusion in this directory is not an endorsement.