title: Efficacy of double-coated probiotics for irritable bowel syndrome: a randomized double-blind controlled trial.
abstract: BACKGROUND
  The purpose of this study was to elucidate the effects of a dual-coated probiotic supplement (Duolac Care) on symptoms of diarrhea-predominant irritable bowel syndrome in a randomized double-blind clinical trial.
  
  
  METHODS
  Fifty subjects with diarrhea-predominant irritable bowel syndrome were randomly assigned to either the non-coating group or the dual-coating group in order to receive two capsules per day of multi-species probiotics containing 5 billion bacteria per capsule for 4 weeks. Data from an adequate relief questionnaire were used in assessment of primary outcome. Daily records of stool frequencies and the Bristol stool scale, a weekly symptom diary using 100-mm visual analog scale, and Beck depression inventories were collected. Blood tests including blood cell counts, interleukin-10, tumor necrosis factor-alpha and inducible nitric oxide synthase, and regulatory T cells-CD4 + CD25highT cells, CD4 + LAP + T cells and CD25high+ LAP + T cells-were analyzed before and after the study. The shift of gut microbiota was investigated using a quantitative real-time polymerase chain reaction assay.
  
  
  RESULTS
  Responses to the adequate relief questionnaire indicated significant improvement in overall discomfort in the dual-coating group and the ratio of normal stools to hard or watery stools had a better effect from dual-coated probiotics compared to non-coated probiotics. This may be due to a shift of intestinal microbiota, as our correlation analysis showed significant negative correlation between Bifidobacterium and urgency of defecation.
  
  
  CONCLUSIONS
  Our result implies that dual-coating layers of probiotic supplement can be a candidate for treatment of diarrhea-predominant irritable bowel syndrome.
authors.affiliation: Department of Rehabilitation Medicine of Korean Medicine, Dongguk University Ilsan Hospital, 814 Siksa-dong, Goyang, Gyeonggi-do, Republic of Korea.
authors.forename: Kyungsun
authors.initials: K
authors.lastname: Han
authors.affiliation: Department of Rehabilitation Medicine of Korean Medicine, Dongguk University Ilsan Hospital, 814 Siksa-dong, Goyang, Gyeonggi-do, Republic of Korea.
authors.forename: Jinghwa
authors.initials: J
authors.lastname: Wang
authors.affiliation: R&D Center, Cell Biotech Co. Ltd., Gimpo, 415-871, Republic of Korea.
authors.forename: Jae-Gu
authors.initials: JG
authors.lastname: Seo
authors.affiliation: Department of Rehabilitation Medicine of Korean Medicine, Dongguk University Ilsan Hospital, 814 Siksa-dong, Goyang, Gyeonggi-do, Republic of Korea. kimklar@dongguk.ac.kr.
authors.forename: Hojun
authors.initials: H
authors.lastname: Kim
mesh_terms: D000328:Adult; D000368:Aged; D000886:Anthropometry / Q000379:methods; D001772:Blood Cell Count; D003967:Diarrhea / Q000628:therapy; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004339:Drug Compounding; D005243:Feces / Q000382:microbiology; D005260:Female; D000069196:Gastrointestinal Microbiome; D006801:Humans; D018836:Inflammation Mediators / Q000378:metabolism; D043183:Irritable Bowel Syndrome / Q000097:blood / Q000276:immunology / Q000382:microbiology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D019936:Probiotics / Q000008:administration & dosage / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016176:T-Lymphocyte Subsets / Q000276:immunology; D055815:Young Adult
chemical_list: D018836:Inflammation Mediators
keywords: Dual-coating technology; Irritable bowel syndrome; Probiotics