Background/aims: 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.
Methods: 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.
Results: 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.
Conclusions: Composite probiotics containing Bifidobacterium bifidum BGN4, Lactobacillus acidophilus AD031, and other species are safe and effective, especially in patients who excrete normal or loose stools.
Keywords: Bifidobacterium bifidum; Irritable bowel syndrome; Probiotics.