qQ-lab Daily-IBS for Irritable Bowel Syndrome
Primary Purpose
Irritable Bowel Syndrome (IBS)
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
gQ-lab daily
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome (IBS)
Eligibility Criteria
Inclusion Criteria:
- Korean men and women aged over 19 and 80
- Patients with IBS meeting the ROME III criteria (Diagnosed with IBS with abdominal discomfort or abdominal pain in the past 3 months and meeting at least two of the following conditions: (1) improvement in defecation; (2) onset of symptoms associated with changes in stool frequency; (3) association with changes in stool form)
- Patients who underwent colonoscopy in the past 5 years and have been confirmed to have no organ abnormalities
- Women who are surgically infertile or fertile women who are negative during pregnancy diagnostic tests (urine or seron- hCG). Fertile women who have "almost no chance of becoming pregnant" during the study period owing to the use of appropriate contraception (e.g., oral contraceptive pills, IUD, double-barrier method, or hormone implants) or men who have agreed to this
- People who have no problems in their nerves and mental systems and who can make their own doctors clear
- The person who agreed in writing to this test
Exclusion Criteria:
- Persons with hypersensitivity to probiotics
- Pregnant or lactating women
- People who have received other clinical trial drugs within the first 3 months of visit 1. (If the patient has received any other clinical trial drug within the past 3 months, contact the client's monitor to determine eligibility on a case-by-case basis.)
- A person who believes that the participant is in a condition or situation in which participation in the clinical trial may be hazardous to the participant
- Patients with severe congestive heart failure or severe angina
- If the patient is diagnosed as having lactose intolerance or immunosuppression
- Patients who are taking or taking medications (medicine for intestinal disorders, lactic acid bacteria) that may affect the test food, probiotics, or during the test period. However, if you are taking the drug, you can take the test after two weeks of abstinence.
- If the systolic blood pressure measured at Visit 1 is greater than 160 mmHg or diastolic blood pressure is greater than 100 mmHg and hypertension is not controlled regardless of whether the medication is administered or not.
- Patients with uncontrolled endocrine diseases (such as diabetes), metabolic diseases (e.g. secondary hyperlipidemia) or hypothyroidism (subjects with a history of hypothyroidism) should receive a stable thyroid hormone supplement for at least 4 weeks prior to visit 1 If you are on therapy, you can participate in this test only if the TSH level measured at Visit 2 is within the normal range.)
- If kidney function is impaired at visit 1 (creatinine> 2.0 mg / dL) or nephrotic syndrome is observed
- If the cancer has developed within the past 5 years (unless it is determined to be cured)
- If there is a history of mental instability and drug / alcohol abuse within the past 5 years, or if major psychiatric illnesses are not adequately controlled and stabilized by medication
- Visits 1 If you have taken mental nerve agents within the previous 3 months
- If you take a systemic steroid preparation within 1 month before visit 1
- Patients who underwent abdominal surgery except for appendectomy, hernia surgery, and cesarean section
- Any person deemed inappropriate for the judgment of the clinician
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
gQ-lab daily
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Symptom questionnaire survey (VAS score)
To assess satisfaction with overall improvement in bowel symptoms, after 4 weeks of administration of GQ lab to patients with irritable bowel syndrome (IBS).
The range of the VAS score is 1 to 10. The lower the value of the VAS score, the better. The value of the endpoint (4 weeks) is compared in the placebo group versus the treatment group.
Secondary Outcome Measures
Full Information
NCT ID
NCT03964103
First Posted
May 21, 2019
Last Updated
May 31, 2019
Sponsor
IlDong Pharmaceutical Co Ltd
1. Study Identification
Unique Protocol Identification Number
NCT03964103
Brief Title
qQ-lab Daily-IBS for Irritable Bowel Syndrome
Official Title
Efficacy and Colon Attachment of gQ-lab Daily for Patients With Irritable Bowel Syndrome: Randomized, Double-blind, Placebo-controlled, Parallel-group Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 4, 2016 (Actual)
Primary Completion Date
November 8, 2017 (Actual)
Study Completion Date
January 22, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IlDong Pharmaceutical Co Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome (IBS)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized, double-blind, placebo-controlled, parallel-group
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
gQ-lab daily
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
gQ-lab daily
Intervention Description
probiotics
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
powdered skim milk, lactose
Primary Outcome Measure Information:
Title
Symptom questionnaire survey (VAS score)
Description
To assess satisfaction with overall improvement in bowel symptoms, after 4 weeks of administration of GQ lab to patients with irritable bowel syndrome (IBS).
The range of the VAS score is 1 to 10. The lower the value of the VAS score, the better. The value of the endpoint (4 weeks) is compared in the placebo group versus the treatment group.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Korean men and women aged over 19 and 80
Patients with IBS meeting the ROME III criteria (Diagnosed with IBS with abdominal discomfort or abdominal pain in the past 3 months and meeting at least two of the following conditions: (1) improvement in defecation; (2) onset of symptoms associated with changes in stool frequency; (3) association with changes in stool form)
Patients who underwent colonoscopy in the past 5 years and have been confirmed to have no organ abnormalities
Women who are surgically infertile or fertile women who are negative during pregnancy diagnostic tests (urine or seron- hCG). Fertile women who have "almost no chance of becoming pregnant" during the study period owing to the use of appropriate contraception (e.g., oral contraceptive pills, IUD, double-barrier method, or hormone implants) or men who have agreed to this
People who have no problems in their nerves and mental systems and who can make their own doctors clear
The person who agreed in writing to this test
Exclusion Criteria:
Persons with hypersensitivity to probiotics
Pregnant or lactating women
People who have received other clinical trial drugs within the first 3 months of visit 1. (If the patient has received any other clinical trial drug within the past 3 months, contact the client's monitor to determine eligibility on a case-by-case basis.)
A person who believes that the participant is in a condition or situation in which participation in the clinical trial may be hazardous to the participant
Patients with severe congestive heart failure or severe angina
If the patient is diagnosed as having lactose intolerance or immunosuppression
Patients who are taking or taking medications (medicine for intestinal disorders, lactic acid bacteria) that may affect the test food, probiotics, or during the test period. However, if you are taking the drug, you can take the test after two weeks of abstinence.
If the systolic blood pressure measured at Visit 1 is greater than 160 mmHg or diastolic blood pressure is greater than 100 mmHg and hypertension is not controlled regardless of whether the medication is administered or not.
Patients with uncontrolled endocrine diseases (such as diabetes), metabolic diseases (e.g. secondary hyperlipidemia) or hypothyroidism (subjects with a history of hypothyroidism) should receive a stable thyroid hormone supplement for at least 4 weeks prior to visit 1 If you are on therapy, you can participate in this test only if the TSH level measured at Visit 2 is within the normal range.)
If kidney function is impaired at visit 1 (creatinine> 2.0 mg / dL) or nephrotic syndrome is observed
If the cancer has developed within the past 5 years (unless it is determined to be cured)
If there is a history of mental instability and drug / alcohol abuse within the past 5 years, or if major psychiatric illnesses are not adequately controlled and stabilized by medication
Visits 1 If you have taken mental nerve agents within the previous 3 months
If you take a systemic steroid preparation within 1 month before visit 1
Patients who underwent abdominal surgery except for appendectomy, hernia surgery, and cesarean section
Any person deemed inappropriate for the judgment of the clinician
12. IPD Sharing Statement
Plan to Share IPD
No
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qQ-lab Daily-IBS for Irritable Bowel Syndrome
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