1. In this randomized controlled trial, the probiotic Bifidobacterium animalis subsp. lactis Bi-07 (Bi-07) was non-inferior to lactase supplementation in treating those with lactose intolerance.
2. Although Bi-07 was associated with better lactose digestion compared to placebo, the odds of nausea were higher in those who received the probiotic.
Evidence Rating Level: 1 (Excellent)
Lactose intolerance is a common condition caused by a decreased expression of lactase enzyme in the small intestine. For patients with lactose intolerance, one potential therapeutic strategy is lactase supplementation. Certain bacteria can also metabolize lactose, however, the effects of these probiotics on lactose digestion require further elucidation. Therefore, the goal of the present study was to determine the effects of the probiotic Bifidobacterium animalis subsp. lactis Bi-07 (Bi-07) on lactose maldigestion.
The study reported 2 randomized cross-over clinical trials that investigated the effects of Bi-07 on lactose digestion. The Booster Alpha study was performed in Germany while the Booster Omega study was in France. Patients were included if they were between the ages of 25 and 60 years, had self-declared or medically diagnosed lactose intolerance, and had a positive lactose challenge result in pre-screening, as defined by an increase of >20 parts per million in a Breath Hydrogen Concentration (BHC) test. Patients with gastrointestinal disorders, diabetes, or prior abdominal surgery were excluded. 68 individuals (34 in each study) were randomized to 6 possible sequences of 3 treatments: (1) Bi-07 (2.40×1012 CFU in Booster Alpha, 2.34×1012 in Booster Omega), (2) 4662 FCC unit lactase, and (3) 6g maltodextrin (placebo). The primary outcome was the difference in BHC (ppm) among the different groups, and secondary outcomes included experiences of gastrointestinal symptoms as determined by patient questionnaires.
The results demonstrated both Bi-07 and lactase to be superior to placebo in modulating BHC levels in the Booster Alpha trial. In the Booster Omega trial, Bi-07 was superior to placebo and non-inferior to lactase. There were no significant differences in rates of gastrointestinal symptoms between Bi-07 and placebo in Booster Alpha, but there was an increased incidence of nausea during Bi-07 treatment in the Booster Omega study. One limitation of this study was the use of an unvalidated gastrointestinal symptom questionnaire which may not have accurately portrayed the effects of the various treatments on gastrointestinal symptoms. Nonetheless, the study results suggested that Bi-07 may be an effective therapeutic strategy for lactose maldigestion.
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