All enrolled participants received comprehensive information about this study, and informed consent
was obtained before any study-related processes began. The study was conducted at Hanyang University Hospital in Korea between March 2011 and August 2011, and was approved by the Clinical Research Ethics Committee of the Hanyang University Hospital of Korea (2010-04-009). After a 2-week run-in period, enrolled patients were randomly assigned to receive either one capsule (500 mg) of LacClean Gold-S (Cell Biotech, Co. Ltd, Gimpo, Korea; a multispecies probiotics) AZD1208 or one capsule (500 mg) of a placebo twice daily (total dosage 1000 mg/day) for 4 weeks (Fig. 1). The patients were instructed to take the study product between meals because the increased gastric pH is more favorable for the ingested bacteria. LacClean Gold-S is a capsule-form probiotics containing six species see more of live bacteria. The six strains of probiotics were Bifidobacterium bifidum (KCTC 12 199BP), Bifidobacterium lactis (KCTC 11 904BP), Bifidobacterium longum (KCTC 12 200BP), Lactobacillus acidophilus (KCTC 11 906BP), Lactobacillus rhamnosus (KCTC 12 202BP), and Streptococcus thermophilus (KCTC 11 870BP). A total of 5 × 109 viable cells in a lyophilized powder form were included in each
capsule and constituted 13.1% (w/w) of the total weight (500 mg/capsule). The amount of probiotics equally consisted in each of the six strains. The dose was determined based on previous studies where the daily doses were MCE公司 between 5 × 107 and 3.6 × 1011 colony forming units (CFUs)/day, and ≥ 5 × 109 CFUs/day has been suggested.[9-11] The placebo powder contained the same
“other ingredients” as the active medication and maltodextrin instead of bacteria. OY Lee and KN Lee enrolled the patients for this study. Patients were allocated to the probiotics or placebo group using a computer-generated randomization schedule with a 1 : 1 allocation ratio. Dr. Jun generated the random allocation sequence, and no one but him knew the allocation sequence. The practice nurse gave a questionnaire and explained the protocol to the patients. The nurse did not know the allocation sequence and met the patients in regular sequence. The patient received the medication from the clinical pharmacist. No one could differentiate the two drugs without the sequence information. Stool samples for fecal microflora analysis were obtained immediately before the start of treatment and at the end of the 4 weeks of treatment. Fecal microbiota was analyzed only from patients who agreed to the stool sample collection. IBS symptoms were assessed by examiners and patients at baseline and week 4 using a questionnaire. Global relief of IBS symptoms, drug compliance, and adverse events were evaluated by a questionnaire after the 4 weeks of treatment. The primary efficacy end-point was the proportion of patients who experienced global relief of IBS symptoms after the 4-week treatment.