A multi-center, randomized, double-blinded, placebo-controlled human study to evaluate the efficacy and safety of GI 7 in Subjects with irritable bowel syndrome

Cell Biotech0 个研究点目标入组 116 人开始时间: 待定最近更新: 2019年3月11日

试验速览

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•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.

•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

发起方

Cell Biotech