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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
IlDong Pharmaceutical Co Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome (IBS)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Korean men and women aged over 19 and 80
  2. 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)
  3. Patients who underwent colonoscopy in the past 5 years and have been confirmed to have no organ abnormalities
  4. 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
  5. People who have no problems in their nerves and mental systems and who can make their own doctors clear
  6. The person who agreed in writing to this test

Exclusion Criteria:

  1. Persons with hypersensitivity to probiotics
  2. Pregnant or lactating women
  3. 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.)
  4. 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
  5. Patients with severe congestive heart failure or severe angina
  6. If the patient is diagnosed as having lactose intolerance or immunosuppression
  7. 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.
  8. 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.
  9. 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.)
  10. If kidney function is impaired at visit 1 (creatinine> 2.0 mg / dL) or nephrotic syndrome is observed
  11. If the cancer has developed within the past 5 years (unless it is determined to be cured)
  12. 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
  13. Visits 1 If you have taken mental nerve agents within the previous 3 months
  14. If you take a systemic steroid preparation within 1 month before visit 1
  15. Patients who underwent abdominal surgery except for appendectomy, hernia surgery, and cesarean section
  16. 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

    First Posted
    May 21, 2019
    Last Updated
    May 31, 2019
    Sponsor
    IlDong Pharmaceutical Co Ltd
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    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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