None listed
Conditions
Interventions
Drug : randomized participants were prescribed to either GI 7 1.4g or placebo 1.4g to administer once a day at each visit for total 8 weeks.
Sponsors
Cell Biotech
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All men and women aged between 19 and 69 years 2. According to Rome III diagnostic criteria, the subject, whose symptoms of the disease manifested before at least 6 month, suffered from abdominal pain or abdominal discomfort for more than 3 days in the last 3 months. Also, more than two of the followings that apply to oneself. A. The symptoms are mitigated by bowel movement. B. Change in bowel movement frequency with the upper symptoms. C. Accompanied stool form change with the upper symptoms. 3. Subjects who have been voluntarily agreed and signed in a consent form. 4. Subjects who filled administration log in at least seven days during observation period. 5. Subjects who have abdominal pain at least twice a week, and have over 30mm of Vas score for weekly arise from abdominal pain at observation period.
Exclusion criteria
Exclusion criteria: 1. Subjects who have any event of hypersensitivity to ingredient and similar product of test food. 2. Subjects who have abnormal findings by colonoscopy or colonography examination. (except the case that removed colon polyps or hyperplasia polyps) 3. Subjects who diagnosed other gastrointestinal diseases exclude IBS that can affect this clinical trial less than one month before screening visit. 4. Subjects who underwent abdominal surgery within 6 months (except, appendectomy, Caesarian section, tubal ligation, laparoscopic cholecystectomy, hysterectomy, abdominal wall hernia repair) 5. History of malignant neoplasm (possible if no relapse for the past 5 years) 6. Subjects who have taken heavy doses of antibiotics or any health functional food including probiotics and GI 7 within 2 weeks 7. Alcohol or substance dependence 8. Pregnant women, breast feeder, women planning a pregnancy and those who do not agree to use adequate contraception 9. Participants in any clinical trial within the 4 weeks prior to screening. 10. Subjects which in the opinion investigator could affect preclude evaluation of response
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom score(Visual Analoge Scale: abdominal pain) | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom score(Visual Analoge Scale: abdominal pain);Symptom score(Visual Analoge Scale: abdominal Discomfort);Bowel function score, Symptom score, Bristol stool form scale;Biomarker analysis(IFN-?, TNF-a, IL-4, IL-6, IL-10, IL-12 );Fecal microbiota analysis;Safety assesment through adverse events, laboratory tests, vital signs | — |
Countries
Korea, Republic of
Contacts
Public ContactInja Jung
Dongguk University Ilsan Hospital
Outcome results
None listed