*Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
†Department of Food and Nutrition, Research Institute of Human Ecology, Seoul National University College of Human Ecology, Seoul, Korea.
‡Research Institute, BIFIDO Co., Ltd., Hongchun, Korea.
Irritable bowel syndrome (IBS) is a troublesome disease. Some strains of probiotics reportedly exert remarkable immunomodulatory effects, and so we designed a prospective double-blind randomized placebo-controlled clinical study to assess their effects in Korean adults with IBS.
IBS patients who met Rome III criteria were randomly assigned to receive composite probiotics or placebo. A total of 20 billion lyophilized bacteria were administered twice daily for 8 weeks. Primary outcome variables were symptom scores consisting of abdominal pain, flatulence, defecation discomfort, and sum of symptom scores. A visual analogue scale was used to quantify the severity. Secondary outcome variables consisted of the quality of life and bowel habits including defecation frequency and stool form.
Thirty-six and 34 patients were randomized to the probiotics and placebo groups, respectively. Intention-to-treat analysis showed significant reductions in pain after 8 weeks of treatment: -31.9 and -17.7 in the probiotics and placebo groups, respectively (p=0.045). The reductions in abdominal pain, defecation discomfort, and sum of scores were more significant in 58 patients with a score of at least 3 on the baseline stool-form scale.
Composite probiotics containing