The Chr Hansen study using its Bifidobacterium animalus BB-12 strain, published in the British Journal of Nutrition, saw improvements in defecation frequency and abdominal discomfort in the 1200 Brits, Germans and French that took part.
The 18-70 year old subjects were healthy but mildly constipated and experiencing abdominal discomfort.
In the randomised, double blind, placebo-controlled study begun in 2010, they were given either placebo, 1bn CFU (colony forming units) or 10bn CFU of BB-12 in a pill once every morning for four weeks.
Those taking BB-12 reported higher defecation frequency and greater abdominal comfort against placebo although the placebo affect was high (often the case in self-reporting qualitative studies). Overall digestive comfort was not significantly different between the groups and there was no difference between the groups on 1bn and 10bn CFU, indicating some kind of efficacy celing.
Defecation frequency was deemed to have improved if participants who were defecating on average three times per week or less, recorded an increase toilet visit of at least one day per week, in at least two of the four study weeks.
Chr Hansen scientific advisor in human health and nutrition, Mikkel Jungersen, told us the study took years to publish because of a lengthy post-hoc analysis and the sheer size of the data set.
“It’s the largest dataset ever published on probiotics and bowel function,” Jungersen said. “We needed to tighten the selection criteria to reduce the impact of the placebo effect. This is very encouraging data.”
Constipation and bowel issues affect about 25% of the world’s population.
In the European Union there are no approved health claims for probiotics or prebiotics and in this light Chr Hansen’s Lasse Nagell, VP human health & nutrition in sales & marketing, told us “We closely monitor the health claim opportunities around the world and will assess if this new dataset will open new claim opportunities.”
Chr Hansen does most of its probiotic business in supplements, foods and also pharmaceuticals.
Jungersen said the firm would continue to invest in probiotic research.
British Journal of Nutrition
“Effect of the probiotic strain Bifidobacterium animalis subsp. lactis, BB-12, on defecation frequency in healthy subjects with low defecation frequency and abdominal discomfort: a randomised, double-blind, placebo-controlled, parallel-group trial”
Authors: Dorte Eskesen, Lillian Jespersen, Birgit Michelsen, Peter J. Whorwell, Stefan Müller-Lissner and Cathrine M. Morberg