diarrhea-predominant irritable bowel syndrome-like symptoms
Conditions
Interventions
Lactobacills brevis KB290 and beta-ene containing capsule (1 capsule/day, for 12 weeks)
placebo capsule (1 capsule/day, for 12 weeks)
Sponsors
IMEQRD Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: People who meet all of the following conditions will be required. 1. Who is suffering from diarrhea with abdominal pain and discomfort. 2. Who can ingest the test food during the 12-week study period. 3. Who can visit the Shiraishi internal medicine clinic during the test period. 4. Who can give informed consent by the document based on the individual's intention before the start of the study.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stool consistency and abdominal pain intensity | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Japan
Contacts
Public ContactYoshitada Hira
IMEQRD Co., Ltd. Planning and Sales Department
Outcome results
None listed