Efficacy and tolerability of α-galactosidase in treating gas-related symptoms in children: a randomized, double-blind, placebo controlled trial

Giovanni Di Nardo, Salvatore Oliva, Federica Ferrari, Saverio Mallardo, Giovanni Barbara, Cesare Cremon, Marina Aloi, Salvatore Cucchiara, Giovanni Di Nardo, Salvatore Oliva, Federica Ferrari, Saverio Mallardo, Giovanni Barbara, Cesare Cremon, Marina Aloi, Salvatore Cucchiara

Abstract

Background: Gas-related symptoms represent very common complaints in children. The reduction of gas production can be considered as a valuable target in controlling symptoms. α-galactosidase has been shown to reduce gas production and related symptoms in adults. To evaluate the efficacy and tolerability of α-galactosidase in the treatment of gas-related symptoms in pediatric patients.

Methods: Single center, randomized, double-blind, placebo-controlled, parallel group study performed in tertiary care setting. Fifty-two pediatric patients (32 female, age range 4-17) with chronic or recurrent gas-related symptoms were randomized to receive placebo (n = 25) or α-galactosidase (n = 27). Both treatments were given as drops or tablets, according to body weight for 2 weeks. The primary endpoint was the reduction in global distress measured by the Faces Pain Scale-Revised (FPS-R) at the end of treatment compared to baseline. Secondary endpoints were the reduction in severity and frequency of gas-related symptoms as recorded by parents and/or children.

Results: α-galactosidase significantly reduced global distress (p = 0.02) compared to placebo. The digestive enzyme decreased the number of days with moderate to severe bloating (p = 0.03) and the proportion of patients with flatulence (p = 0.02). No significant differences were found for abdominal spasms and abdominal distension. No adverse events were reported during treatment.

Conclusions: Although larger and longer trials are needed to confirm this result, α-galactosidase seems to be a safe, well tolerated and effective treatment for gas-related symptoms in the pediatric population.

Trial registration: ClinicalTrials.gov, NCT01595932.

Figures

Figure 1
Figure 1
Study flow chart.
Figure 2
Figure 2
Change of FPS-score in any patient before and after the treatment.
Figure 3
Figure 3
Physician overall evaluation at end of treatment and at follow-up.

References

    1. Longstreth GF. et al.Functional bowel disorders. Gastroenterology. 2006;130:1480–1491. doi: 10.1053/j.gastro.2005.11.061.
    1. Sandler RS, Stewart WF, Liberman JN. et al.Abdominal pain, bloating and diarrhea in the United States: prevalence and impact. Dig Dis Sci. 2000;45:1166–1171. doi: 10.1023/A:1005554103531.
    1. Youssef NN. et al.Quality of life for children with functional abdominal pain: a comparison study of patients’ and parents’ perceptions. Pediatrics. 2006;117:54–59. doi: 10.1542/peds.2005-0114.
    1. Spiller R. New insights into bloating and abdominal distension: is it all outlet obstruction? Am J Gastroenterol. 2010;105:888–889. doi: 10.1038/ajg.2010.57.
    1. Lea R, Whorwell PJ. Expert commentary – bloating, distension, and the irritable bowel syndrome. MedGenMed. 2005;7:18.
    1. Issa B, Wafaei NA, Whorwell PJ. Abdominal bloating and distension: what is the role of the microbiota. Dig Dis Sci. 2012;57:4–8. doi: 10.1007/s10620-011-1834-4.
    1. Fink RN, Lembo AJ. Intestinal gas. Curr Treat Options Gastroenterol. 2001 Aug;4:333–337. doi: 10.1007/s11938-001-0059-6.
    1. Jones M. Bloating and intestinal gas. Curr Treat Options Gastroenterol. 2005;8:311–318. doi: 10.1007/s11938-005-0024-x.
    1. Friis H, Bod’e S, Rumessen JJ. et al.Effect of simethicone on lactulose-induced H2 production and gastrointestinal symptoms. Digestion. 1991;49:227–230. doi: 10.1159/000200726.
    1. Suarez FL, Furne J, Springfield J, Levitt MD. Failure of activated charcoal to reduce the release of gases produced by the colonic flora. Am J Gastroenterol. 1999;94:208–212. doi: 10.1111/j.1572-0241.1999.00798.x.
    1. O’Mahony L, McCarthy J, Kelly P. et al.Lactobacillus and bifidobacterium in irritable bowel syndrome: symptom responses and relationship to cytokine profiles. Gastroenterology. 2005;128:541–551. doi: 10.1053/j.gastro.2004.11.050.
    1. Guandalini S, Magazzù G, Chiaro A. et al.VSL#3 improves symptoms in children with irritable bowel syndrome: a multicenter, randomized, placebo-controlled, double-blind, crossover study. J Pediatr Gastroenterol Nutr. 2010;51:24–30. doi: 10.1097/MPG.0b013e3181ca4d95.
    1. Ganiats TG, Norcross WA, Halverson AL. et al.Does beano prevent gas? A double-blind crossover study of oral alfa-galactosidase to treat dietary oligosaccharide intolerance. J Fam Pract. 1994;39:441–445.
    1. Solomons N. et al.Orally-ingested, microbial alpha-galactosidases produce effective in vivo, intraintestinal digestion of the Bean oligosaccharide, raffinose. Gastroenterology. 1991;100:A251.
    1. Di Stefano M, Miceli E, Gotti S. et al.The effect of oral α-galactosidase on intestinal gas production and gas-related symptoms. Dig Dis Sci. 2007;52:78–83. doi: 10.1007/s10620-006-9296-9.
    1. Rippel SW. et al.Pediatric patients with dyspepsia have chronic symptoms, anxiety, and lower quality of life as adolescents and adults. Gastroenterology. 2012;142:754–761. doi: 10.1053/j.gastro.2011.12.043.
    1. Saps M. et al.Multicenter, randomized, placebo-controlled trial of amitriptyline in children with functional gastrointestinal disorders. Gastroenterology. 2009;137:1261–1269. doi: 10.1053/j.gastro.2009.06.060.
    1. Hicks CL. et al.The faces pain scale-revised: toward a common metric in pediatric pain measurement. Pain. 2001;93:173–183. doi: 10.1016/S0304-3959(01)00314-1.
    1. Irvine EJ. et al.Design of treatment trials for functional gastrointestinal disorders. Gastroenterology. 2006;130:1538–1551. doi: 10.1053/j.gastro.2005.11.058.
    1. Spiller R, Aziz Q, Creed F. et al.Guidelines on the irritable bowel syndrome: mechanisms and practical management. Gut. 2007;56:1770–1798. doi: 10.1136/gut.2007.119446.
    1. Pimentel M, Lembo A, Chey WD. et al.Rifaximin therapy for patients with irritable bowel syndrome without constipation. N Engl J Med. 2011;364:22–32. doi: 10.1056/NEJMoa1004409.
    1. Schmulson M, Chang L. Review article: the treatment of functional abdominal bloating and distension. Aliment Pharmacol Ther. 2011;33:1071–1086. doi: 10.1111/j.1365-2036.2011.04637.x.

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