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qQ-lab Daily-IBS for Irritable Bowel Syndrome

NCT03964103 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-06-04

No results posted yet for this study

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

  • Irritable Bowel Syndrome (IBS)

Interventions

DIETARY_SUPPLEMENT

gQ-lab daily

probiotics

DIETARY_SUPPLEMENT

Placebo

powdered skim milk, lactose

Sponsors & Collaborators

  • IlDong Pharmaceutical Co Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-04
Primary Completion
2017-11-08
Completion
2018-01-22

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03964103 on ClinicalTrials.gov