The multi-centre, randomised, double blind, controlled trial evaluated the effect of a probiotic functional food dairy product against a non-probiotic dairy product on symptoms in IBS – finding that the probiotic product offered no significant benefit over a the placebo.
Led by Professor Richard Hobbs of Oxford University, UK, the clinical trial of the commercially available probiotic fermented yoghurt product (containing bifidobacterium animalis DN-173010) in community based IBS patients found that both the probiotic and placebo control product led to significant improvement across a range of symptom and quality of life outcomes.
“Significant improvements were reported for most outcomes in all trial participants but improvement did not differ by intervention or placebo group,” said Hobbs and his team.
“This trial therefore does not provide evidence for effectiveness of a probiotic in IBS, in variance with much published literature and review conclusions.”
Study details
Hobbs and his team stated that previous evidence has suggested that functional foods containing probiotics can improve gastrointestinal transit, but noted that “data are limited by short follow-up periods and evaluation in selected populations.”
The new multi-centre, randomized, double blind, controlled trial to evaluate the effect of a probiotic vs non-probiotic dairy product on symptoms in IBS with a constipation element.
A total of 179 participants were randomised to consume dairy ‘yoghurt’ products which either did or did not contain active probiotics twice daily and to complete a daily diary.
The primary outcome was subjective global assessment of symptom relief at week 4. Other outcomes were: IBS symptom scores, pain, bloating and flatulence levels, stool frequency, stool consistency, ease of bowel movement and quality of life.
The team found no significant difference between the probiotic and placebo groups at 4 weeks (57% active vs 53% placebo, reported adequate relief (p = 0.71)).
By weeks eight and 12 the team found that those receiving placebo had better pain relief than those receiving the probiotic (46% active vs 68% placebo).
“The sustained and large improvement observed in both groups suggests there may be benefit from regular consumption of a dairy product but does not suggest any additional benefit of the addition of a probiotic to such products,” the team commented.
Source: BMC Gastroenterology
Published online ahead of print, doi: 10.1186/1471-230X-13-45
“A randomised controlled trial of a probiotic ‘functional food’ in the management of irritable bowel syndrome”
Authors: Lesley M Roberts, Deborah McCahon, Roger Holder, et al