title: Randomized trial of dietary fiber and Lactobacillus casei administration for prevention of colorectal tumors.
abstract: The epidemiologic evidence that dietary fiber protects against colorectal cancer is equivocal. No large-scale clinical study of the administration of Lactobacillus casei has been reported. We examined whether dietary fiber and L. casei prevented the occurrence of colorectal tumors. Subjects were 398 men and women presently free from tumor who had had at least 2 colorectal tumors removed. Subjects were randomly assigned to 4 groups administered wheat bran, L. casei, both or neither. The primary end point was the presence or absence of new colorectal tumor(s) diagnosed by colonoscopy after 2 and 4 years. Among 380 subjects who completed the study, 95, 96, 96 and 93 were assigned to the wheat bran, L. casei, both and no treatment groups, respectively. Multivariate adjusted ORs for occurrence of tumors were 1.31 (95% CI 0.87-1.98) in the wheat bran group and 0.76 (0.50-1.15) in the L. casei group compared to the control group. There was a significantly higher number of large tumors after 4 years in the wheat bran group. The occurrence rate of tumors with a grade of moderate atypia or higher was significantly lower in the group administered L. casei. No significant difference in the development of new colorectal tumors was observed with administration of either wheat bran or L. casei. However, our results suggest that L. casei prevented atypia of colorectal tumors.
authors.affiliation: Laboratory of Hereditary Tumors, Institute for Advanced Medical Sciences, Hyogo College of Medicine, Osaka, Japan. cancer@gol.com
authors.forename: Hideki
authors.initials: H
authors.lastname: Ishikawa
authors.forename: Ikuko
authors.initials: I
authors.lastname: Akedo
authors.forename: Toru
authors.initials: T
authors.lastname: Otani
authors.forename: Takaichiro
authors.initials: T
authors.lastname: Suzuki
authors.forename: Tomiyo
authors.initials: T
authors.lastname: Nakamura
authors.forename: Ikuko
authors.initials: I
authors.lastname: Takeyama
authors.forename: Shingo
authors.initials: S
authors.lastname: Ishiguro
authors.forename: Etsuo
authors.initials: E
authors.lastname: Miyaoka
authors.forename: Tomotaka
authors.initials: T
authors.lastname: Sobue
authors.forename: Tadao
authors.initials: T
authors.lastname: Kakizoe
mesh_terms: D000328:Adult; D000368:Aged; D003113:Colonoscopy; D015179:Colorectal Neoplasms / Q000517:prevention & control*; D004043:Dietary Fiber / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007780:Lacticaseibacillus casei; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D019936:Probiotics / Q000627:therapeutic use*