Clinical trial: gluten microchallenge with wheat-based starch hydrolysates in coeliac disease patients - a randomized, double-blind, placebo-controlled study to evaluate safety.

BACKGROUND: Wheat-based starch hydrolysates such as glucose syrups, dextrose and maltodextrins are found in more than 50% of European processed food. These products contain low amounts of residual gluten and it has been questioned whether they are safe for coeliac disease patients. AIM: To investigate whether coeliac disease patients can safely consume wheat-based starch hydrolysate products.
METHODS: This randomized, double-blind, placebo-controlled, prospective follow-up study involved 90 coeliac disease patients in remission randomized to consume glucose syrups, maltodextrins or placebo for 24 weeks. Small bowel mucosal morphology and inflammation, symptoms, coeliac serology and malabsorption laboratory data were evaluated at baseline and at the end of the study.
RESULTS: Daily ingestion of wheat-based starch hydrolysates, glucose syrups and maltodextrins, had no deleterious effect on small-bowel mucosal villous architecture or inflammation in coeliac disease patients when compared to the placebo group. Neither were there any significant differences in gastrointestinal symptoms, serology or malabsorption parameters after 24 weeks.
CONCLUSIONS: Wheat-based starch hydrolysates, glucose syrups and maltodextrins did not have harmful effect on coeliac disease patients. Coeliac patients can thus safely continue to consume these products.

RCT Entities:   Population Interventions Outcomes