Efficacy of microbial cell preparation in improving chronic constipation: a randomized, double-blind, placebo-controlled trial.

BACKGROUND & AIMS Probiotics is an emerging therapeutic agent which may alleviate the symptoms of constipation. We evaluated the effectiveness of microbial cell preparation (Hexbio(®)) containing fructooligosaccharide, Bifidobacterium and Lactobacillus in improving stool frequency and symptoms of chronic constipation. METHODS A total of 120 constipated adults diagnosed using Rome III criteria were randomized and given either microbial cell preparation or placebo to be consumed twice daily. Follow-up was done after a 7-day intervention based on a questionnaire which includes an assessment of symptom profile and a stool diary. RESULTS During the intervention period, the stool frequency was higher (p = 0.001) in the treatment group. Subjects experienced less straining (p = 0.001) and sensation of incomplete evacuation (p < 0.001), as well as improved stool consistency (p < 0.001) compared to the placebo group. While a higher proportion of subjects in the treatment group had a reduction in anorectal blockage sensation and having to defecate by manual maneuvers, the differences were not statistically significant. CONCLUSION The results suggest that microbial cell preparation is effective in improving stool frequency and stool consistency. Furthermore, it could reduce the symptoms of straining and sensation of incomplete evacuation in adults with chronic functional constipation. MREC REG NO 866.59 (IRB, UMMC, Malaysia).