The efficacy of bifidobacterium preparation LKM512 for rectal aberrant crypt foci: A double-blind randomized controlled trial
Phase 2
- Conditions
- Patients with both resectable colorectal adenoma/carcinoma in situ by colonoscopy and rectal ACF
- Registration Number
- JPRN-UMIN000023899
- Lead Sponsor
- Yokohama City Univesity
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
1.History of regular use of Lactobacillous, Bifidobacterium preparation supplements. 2.History of regular use (defined as at least once per week) of NSAIDs and/or aspirin. 3.History of heart failure, renal failure, liver cirrhosis or chronic hepatic failure 4.History of familial adenomatous polyposis 5.History of hereditary non-polyposis colorectal cancer 6.History of inflammatory bowel disease 7.Pregnancy or possibility of pregnancy 8.Patients judged as inappropriate candidates for the trial by the investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The amount of change of rectal ACF
- Secondary Outcome Measures
Name Time Method The change of microbiota Safety The cell-proliferative and apoptotic activities in the colorectal epithelium and adenoma/cancer