A pilot trial on subjects with lactose and/or oligosaccharides intolerance treated with a fixed mixture of pure and enteric-coated α- and ß-galactosidase

Abstract

Francesco Di Pierro,1 Alexander Bertuccioli,2 Eleonora Marini,3 Leandro Ivaldi4 1Velleja Research, Milan, Italy; 2Italian Association Fitness and Medicine, Fano, PU, Italy; 3Pharmextracta, Pontenure, Piacenza, Italy; 4Digestive Endoscopic Department, Ceva Hospital, Ceva, Cuneo, Italy Aim: Lactose and complex carbohydrates maldigestion, common food intolerances due to low gut content of α- and ß-galactosidase, lead to abdominal symptoms including pain, diarrhea, bloating, flatulence, and cramping. Commonly, intolerant patients are advised by physicians to avoid the offending foods (dairy foods, cereals, beans, etc). This food-limiting option, however, has possible nutritional risks. We have therefore evaluated the impact of using pure, enteric-coated α- plus ß-galactosidase on gut symptoms in intolerant subjects instead of avoidance of the offending foods. Methods: Sixteen subjects intolerant to lactose and/or complex carbohydrates were enrolled and evaluated in terms of gut symptoms with 1) uncontrolled diet, 2) diet devoid of offending foods, and 3) uncontrolled diet along with pure, enteric-coated α- and ß-galactosidase (DDM Galactosidase®). Results: Even with the uncontrolled diet, intolerant subjects treated with DDM Galactosidase® exhibited reduced gut symptoms (bloating, flatulence, diarrhea, and constipation) significantly better than the control treatment as well as having a diet devoid of offending foods. Conclusion: DDM Galactosidase® is a valid and safe optional treatment to counteract lactose and complex carbohydrate intolerance in subjects who prefer not to avoid, at least partially, offending foods. Keywords: lactase, lactose intolerance, complex carbohydrate intolerance