| Effect | Increase |
| Values | 0-6 scale, 6 being the worst. mean ± SD. Placebo: 0.6 ± 1.1 Low dose: 0.4 ± 0.9 High dose: 0.3 ± 0.4 Median (25/75th percentile). Placebo: 0.0 (0.0/1.0) Low dose: 0.0 (0.0/0.3) High dose: 0.0 (0.0/0.3) |
| Trial Design | Randomized trial |
| Trial Length | 24 hours |
| Number of Subjects | 30 |
| Sex | Both Genders |
In a randomized, double-blind crossover trial, 30 participants with lactose interface were subjected to breath hydrogen tests in response to 12.5 g of lactose + a placebo, yogurt, 3300 FCC acid lactase, 9000 FCC acid lactase, or lactase + yogurt. For our purposes, the lactase groups compared with the placebo are relevant.Funding issues for this study:
One subject was lost to follow-up and 5 were excluded because it was discovered that they were not lactose-intolerant, leaving 24 for the per-protocol analysis.
There was a statistically significant lower breath hydrogen in the lactase groups than the placebo group, with no notable differences between lactase groups. There were also statistically significant reductions in abdominal pain and flatulence, with the higher dose group seeing superiority for flatulence. There were no statistically significant differences in stool consistency or nausea.
"MV carried out breath hydrogen measurements for the Vitacare
GmbH & Co. KG, Bad Vilbel, Germany and also gave statistical
advice for this company. None of the other authors had any personal or financial conflicts of interest."
