Fermented milk products containing Bifidobacterium breve strain Yakult (BFM) are said to possibly improve the clinical status of UC patients.
To determine BFM's efficacy in maintaining remission in Japanese individuals with quiescent UC, Japanese researchers conducted a double-blind study involving 195 patients with quiescent UC.
They were randomly assigned to receive either one pack of BFM fermented milk (10 billion B. breve strain Yakult bacteria and one billion Lactobacillus acidophilus bacteria), or a matching placebo every day for 48 weeks, with the primary outcome being relapse-free survival.
After 48 weeks, the researchers reported that "relapse-free survival was not significantly different between BFM and placebo groups, nor was the incidence of relapse".
Because of this, the study was discontinued for "lack of efficacy".
However, although an exploratory analysis of faecal samples from a sub-group of patients showed no effects of either BFM fermented milk or the matching placebo on the patients' intestinal microbiota, there was indeed a marked reduction in Bifidobacterium species prior to a relapse.
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This applied to both the treatment and control groups.
It was also noted that three "mild adverse events" occurred, and a causal link between both the treatment and placebo beverages and these events "could not be ruled out": one patient in the placebo group experienced abdominal bloating and stress, while one patient in the BFM group was found to have developed body odour during the treatment period.
Not enough bacteria?
The researchers wrote that there was an insufficient number of bacteria and species in the BFM beverage, which was a potential limitation of the study.
The lack of efficacy could also have been explained by the delivery format. An earlier study had found that B. breve strain Yakult in powdered form had beneficial effects on UC patients, but the study's results could have been influenced by the concomitant administration of galacto-oligosaccharides.
The researchers were also unable to determine whether or not B. breve strain Yakult had any impact on the patients' mucosal status, as they did not perform endoscopic analysis.
They concluded: "B. breve strain Yakult had no effect on the time to relapse in UC patients. However, this might reflect the method of delivery or dosage of Bifdobacterium species rather than the efficacy of the bacterial culture itself, as previous studies demonstrated beneficial effects of Bifdobacteria.
"To effectively gauge the efficacy of probiotics in UC, future studies should compare the effects of different probiotics, combinations, dosing regimens, and delivery modes and take into account specific patient populations and disease severity."
Source: Digestive Diseases and Sciences
"Efficacy of Bifidobacterium breve Fermented Milk in Maintaining Remission of Ulcerative Colitis"
Authors: Katsuyoshi Matsuoka, et al.