Irritable Bowel Syndrome (IBS)NCT03964103
qQ-lab Daily-IBS for Irritable Bowel Syndrome
A study testing gQ-lab daily in people with Irritable Bowel Syndrome (IBS), run by IlDong Pharmaceutical Co Ltd.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Irritable Bowel Syndrome (IBS)
- What is being tested?
- gQ-lab daily
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 4 Oct 2016to 22 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
About this study
Official title: Efficacy and Colon Attachment of gQ-lab Daily for Patients With Irritable Bowel Syndrome: Randomized, Double-blind, Placebo-controlled, Parallel-group Study
- 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)
- Being tested
- gQ-lab daily, Placebo
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gQ-lab dailyDietary supplement
probiotics
PlaceboDietary supplement
powdered skim milk, lactose
| Study group | Role | What they receive |
|---|---|---|
| gQ-lab daily | Experimental | Not described Receives: Dietary Supplement: gQ-lab daily |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start4 Oct 2016
- Primary completion8 Nov 2017
- Study completion22 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome (IBS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind, placebo-controlled, parallel-group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964103
- Sponsor's protocol ID
- qQ-lab daily-IBS
- Status last verified
- May 2019
- First submitted
- 21 May 2019
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Colon Attachment of gQ-lab Daily for Patients With Irritable Bowel Syndrome: Randomized, Double-blind, Placebo-controlled, Parallel-group Study
- ClinicalTrials.gov ID
- NCT03964103
- Acronym / sponsor ID
- qQ-lab daily-IBS
- Conditions
- Irritable Bowel Syndrome (IBS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2016 (actual)
- Primary completion
- 8 Nov 2017 (actual)
- Study completion
- 22 Jan 2018 (actual)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- randomized, double-blind, placebo-controlled, parallel-group
| Arm | Type | Receives |
|---|---|---|
| gQ-lab daily | Experimental | Dietary Supplement: gQ-lab daily |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gQ-lab dailyprobiotics | Dietary supplement | gQ-lab daily |
| Placebopowdered skim milk, lactose | Dietary supplement | Placebo |
Primary outcome
Symptom questionnaire survey (VAS score)
Time frame: 4 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Individual participant dataSharing planned: No
Related trials for Irritable Bowel Syndrome (IBS)
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing gQ-lab daily in people with Irritable Bowel Syndrome (IBS), run by IlDong Pharmaceutical Co Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom questionnaire survey (VAS score) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2019.