Effect of a fermented milk containing <i>Bifidobacterium animalis</i> DN‐173 010 on the health‐related quality of life and symptoms in irritable bowel syndrome in adults in primary care: a multicentre, randomized, double‐blind, controlled trial

TLDR

Health‑related quality of life is rarely used as a primary endpoint in probiotic studies of irritable bowel syndrome. The study aimed to compare the effects of fermented milk containing Bifidobacterium animalis DN‑173 010 with heat‑treated yoghurt on IBS symptoms and HRQoL. A total of 274 adults with constipation‑predominant IBS were randomized to 6 weeks of the test fermented milk or control yoghurt, with HRQoL and digestive symptoms measured at 3 and 6 weeks. The probiotic group showed a higher responder rate for HRQoL discomfort (65.2 % vs 47.7 %) and a greater reduction in bloating, and stool frequency increased in those with fewer than three stools per week, while both groups improved in overall HRQoL discomfort.

Abstract

Summary Background Health‐related quality of life (HRQoL) has been rarely evaluated as a primary endpoint in the assessment of the effect of probiotics on the irritable bowel syndrome (IBS). Aim To study the effects of fermented milk containing Bifidobacterium animalis DN‐173 010 and yoghurt strains on the IBS in a multicentre, double‐blind, controlled trial. Methods A total of 274 primary care adults with constipation‐predominant IBS (Rome II) were randomized to consume for 6 weeks either the test fermented milk or a heat‐treated yoghurt (control). HRQoL and digestive symptoms were assessed after 3 and 6 weeks on an intention‐to‐treat population of 267 subjects. Results The HRQoL discomfort score, the primary endpoint, improved ( P &lt; 0.001) in both groups at weeks 3 and 6. The responder rate for the HRQoL discomfort score was higher (65.2 vs. 47.7%, P &lt; 0.005), as was the decrease in bloating score [0.56 ± (s.d.)1.01 vs. 0.31 ± 0.87, P = 0.03], at week 3 in the test vs. the control group. In those subjects with &lt;3 stools/week, stool frequency increased ( P &lt; 0.001) over 6 weeks in the test vs. control group. Conclusions This study suggests a beneficial effect of a probiotic food on discomfort HRQoL score and bloating in constipation‐predominant IBS, and on stool frequency in subjects with &lt;3 stools/week.