Preventive effect of combination of the Lactobacillus brevis KB290 and beta-carotene on diarrhea-predominant irritable bowel syndrome-like symptoms
- Conditions
- diarrhea-predominant irritable bowel syndrome-like symptoms
- Registration Number
- JPRN-UMIN000018002
- Lead Sponsor
- imeQ Co.Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 44
Not provided
People who meet any of the following conditions will be excluded. 1. Who is likely to be inflammatory bowel disease, gastrointestinal ulcers, pancreatitis, celiac disease, lactose intolerance, protozoan infection, parasitic infection, other organic gastrointestinal disease or pregnant women. 2. Who uses commercially available drug or a quasi-drugs, for the prevention and treatment of diarrhea with abdominal pain and abdominal discomfort, on a daily basis. 3. Who is currently going to hospital for the treatment of diarrhea with abdominal pain and abdominal discomfort. 4. Who is judged by principal investigator to require medical treatment because of severe diarrhea with abdominal pain and abdominal discomfort. 5. Who has been diagnosed with irritable bowel syndrome. 6. Who has experienced a gastrointestinal surgery, excluding operation for appendicitis. 7. Who is in breast-feeding or pregnancy, or wishes to become pregnant during the study period. 8. Who has been treated for some systemic disease. 9. Who uses non-steroidal anti-inflammatory drugs, steroids or antibiotics on a daily basis. 10. Who is smoker -excluding who have quitted smoking for one year or more. 11. Who has an abnormality in the blood test excluding who is judged by principal investigator as in range of physiological variation. 12. Who had participated in a clinical trial within 90 days before a screening test. 13. Who is irresponsible-mental illness, dementia etc. 14. Who might suffer allergic reaction to the test food -soy, gelatin, egg, milk, wheat, peanut, buckwheat, shrimp, crab, orange, apple or peach. 15. Who is judged as ineligible by principal investigators or researchers.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stool consistency and abdominal pain intensity
- Secondary Outcome Measures
Name Time Method Defecation frequency, urgency, abdominal discomfort, bloating, incomplete evacuation, straining, passage of gas, rugitus and the total score of them (including stool consistency and abdominal pain), work productivity, QOL, inflammatory markers (Interleukin-1beta, Interleukin-12 and Interleukin-10).