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  5. Randomized feeding intervention in infants at high risk for coeliac disease; the PreventCD study

Randomized feeding intervention in infants at high risk for coeliac disease; the PreventCD study

Sabine VriezingaDr Sabine Vriezinga

Sabine Vriezinga, MD, completed her medical degree in 2012 at the University of Leiden, the Netherlands. She is currently a PhD fellow in the department of paediatrics of Leiden University Medical Center. Sabine focuses on preventive strategies and improvement of care for childhood coeliac disease. She works for the multicentre PreventCD project, investigating whether changing infant feeding practices can prevent coeliac disease. In October 2014, the results of this study were published in the New England Journal of Medicine. Additionally, she works on the ongoing study CoelKids, a project investigating innovation of care, via e-consulting and rapid tests, for children and young adults with coeliac disease in The Netherlands. 

 

Abstract

A window of opportunity has been suggested for reducing the risk of coeliac disease by introducing gluten to infants at four to six months of age.

This is a multicentre, randomized, double blind, placebo controlled dietary intervention study involving 944 children who were positive for HLA-DQ2 or HLA-DQ8 and had at least one first degree relative with coeliac disease. From 16 to 24 weeks of age, 475 participants received 100 mg of immunologically active gluten daily, and 469 received placebo. Antitransglutaminase type 2 and antigliadin antibodies were periodically measured. The primary outcome was the frequency of biopsy confirmed coeliac disease at three years of age.

Coeliac disease was confirmed by means of biopsies in 77 children. To avoid underestimation of the frequency of coeliac disease, three additional children who received a diagnosis of coeliac disease according to the 2012 European Society for Paediatric Gastroenterology, Hepatology, and Nutrition diagnostic criteria (without having undergone biopsies) were included in the analyses (80 children; median age, 2.8 years; 59% were girls). The cumulative incidence of coeliac disease among patients three years of age was 5.2% (95% confidence interval [CI], 3.6 to 6.8), with similar rates in the gluten group and the placebo group (5.9% [95% CI, 3.7 to 8.1] and 4.5% [95% CI, 2.5 to 6.5], respectively; hazard ratio in the gluten group, 1.23; 95% CI, 0.79 to 1.91). Rates of elevated levels of antitransglutaminase type 2 and antigliadin antibodies were also similar in the two study groups (7.0% [95% CI, 4.7 to 9.4] in the gluten group and 5.7% [95% CI, 3.5 to 7.9] in the placebo group; hazard ratio, 1.14; 95% CI, 0.76 to 1.73). Breast-feeding, regardless of whether it was exclusive or whether it was ongoing during gluten introduction, did not significantly influence the development of coeliac disease or the effect of the intervention.

As compared with placebo, the introduction of small quantities of gluten at 16 to 24 weeks of age did not reduce the risk of coeliac disease by three years of age in this group of high risk children. (Funded by the European Commission and others; PreventCD Current Controlled Trials Number, ISRCTN74582487)

Vriezinga SL et al. (2014) Randomized feeding intervention in infants at high risk for celiac disease. N Engl J Med Oct 2; 371(14): 1304-15

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