Efficacy of double-coated probiotics for irritable bowel syndrome: a randomized double-blind controlled trial
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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.
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 + CD25high T 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.
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.
Our result implies that dual-coating layers of probiotic supplement can be a candidate for treatment of diarrhea-predominant irritable bowel syndrome.
KeywordsProbiotics Irritable bowel syndrome Dual-coating technology
This study was supported financially by Cell Biotech.
Compliance with ethical standards
Conflict of interest
H Kim received funds from CellBiotech. JG Seo is an employee of CellBiotech, which does not affect the result or interpretation of the study. Other authors do not have any conflict of interest.
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