Randomized feeding intervention in infants at high risk for celiac disease
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2014
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| author | Vriezinga, Sabine L. Auricchio, Renata Bravi, Enzo Castillejo, Gemma Chmielewska, Anna Crespo-Escobar, Paula Kolaček, Sanja Koletzko, Sibylle Korponay-Szabo, Ilma R. Mummert, Eckart Polanco, Isabel Putter, Hein Ribes-Koninckx, Carmen Shamir, Raanan Szajewska, Hania Werkstetter, Katharina Greco, Luigi Gyimesi, Judit Hartman, Corina Hogen Esch, Caroline Hopman, Erica Ivarsson, Anneli Koltai, Tunde Koning, Frits Martinez-Ojinaga, Eva te Marvelde, Chantal Mocic Pavic, Ana Romanos, Jihane Stoopman, Els Villanacci, Vincenzo Wijmenga, Cisca Troncone, Ricardo Mearin, Maria Luisa |
| author_facet | Vriezinga, Sabine L. Auricchio, Renata Bravi, Enzo Castillejo, Gemma Chmielewska, Anna Crespo-Escobar, Paula Kolaček, Sanja Koletzko, Sibylle Korponay-Szabo, Ilma R. Mummert, Eckart Polanco, Isabel Putter, Hein Ribes-Koninckx, Carmen Shamir, Raanan Szajewska, Hania Werkstetter, Katharina Greco, Luigi Gyimesi, Judit Hartman, Corina Hogen Esch, Caroline Hopman, Erica Ivarsson, Anneli Koltai, Tunde Koning, Frits Martinez-Ojinaga, Eva te Marvelde, Chantal Mocic Pavic, Ana Romanos, Jihane Stoopman, Els Villanacci, Vincenzo Wijmenga, Cisca Troncone, Ricardo Mearin, Maria Luisa |
| contents | <p><strong>Background: </strong>A window of opportunity has been suggested for reducing the risk of celiac disease by introducing gluten to infants at 4 to 6 months of age.</p> <p><strong>Methods: </strong>We performed a multicenter, 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 celiac disease. From 16 to 24 weeks of age, 475 participants received 100 mg of immunologically active gluten daily, and 469 received placebo. Anti-transglutaminase type 2 and antigliadin antibodies were periodically measured. The primary outcome was the frequency of biopsy-confirmed celiac disease at 3 years of age.</p> <p><strong>Results: </strong>Celiac disease was confirmed by means of biopsies in 77 children. To avoid underestimation of the frequency of celiac disease, 3 additional children who received a diagnosis of celiac disease according to the 2012 European Society for Pediatric 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 celiac disease among patients 3 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 anti-transglutaminase 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 celiac disease or the effect of the intervention.</p> <p><strong>Conclusions: </strong>As compared with placebo, the introduction of small quantities of gluten at 16 to 24 weeks of age did not reduce the risk of celiac disease by 3 years of age in this group of high-risk children. (Funded by the European Commission and others; PreventCD Current Controlled Trials number, ISRCTN74582487.).</p> |
| format | Recurso digital |
| id | zenodo_https___doi_org_10_1056_NEJMoa1404172 |
| institution | Zenodo |
| language | eng |
| publishDate | 2014 |
| publisher | Zenodo |
| record_format | zenodo |
| spellingShingle | Randomized feeding intervention in infants at high risk for celiac disease Vriezinga, Sabine L. Auricchio, Renata Bravi, Enzo Castillejo, Gemma Chmielewska, Anna Crespo-Escobar, Paula Kolaček, Sanja Koletzko, Sibylle Korponay-Szabo, Ilma R. Mummert, Eckart Polanco, Isabel Putter, Hein Ribes-Koninckx, Carmen Shamir, Raanan Szajewska, Hania Werkstetter, Katharina Greco, Luigi Gyimesi, Judit Hartman, Corina Hogen Esch, Caroline Hopman, Erica Ivarsson, Anneli Koltai, Tunde Koning, Frits Martinez-Ojinaga, Eva te Marvelde, Chantal Mocic Pavic, Ana Romanos, Jihane Stoopman, Els Villanacci, Vincenzo Wijmenga, Cisca Troncone, Ricardo Mearin, Maria Luisa Celiac Disease <p><strong>Background: </strong>A window of opportunity has been suggested for reducing the risk of celiac disease by introducing gluten to infants at 4 to 6 months of age.</p> <p><strong>Methods: </strong>We performed a multicenter, 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 celiac disease. From 16 to 24 weeks of age, 475 participants received 100 mg of immunologically active gluten daily, and 469 received placebo. Anti-transglutaminase type 2 and antigliadin antibodies were periodically measured. The primary outcome was the frequency of biopsy-confirmed celiac disease at 3 years of age.</p> <p><strong>Results: </strong>Celiac disease was confirmed by means of biopsies in 77 children. To avoid underestimation of the frequency of celiac disease, 3 additional children who received a diagnosis of celiac disease according to the 2012 European Society for Pediatric 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 celiac disease among patients 3 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 anti-transglutaminase 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 celiac disease or the effect of the intervention.</p> <p><strong>Conclusions: </strong>As compared with placebo, the introduction of small quantities of gluten at 16 to 24 weeks of age did not reduce the risk of celiac disease by 3 years of age in this group of high-risk children. (Funded by the European Commission and others; PreventCD Current Controlled Trials number, ISRCTN74582487.).</p> |
| title | Randomized feeding intervention in infants at high risk for celiac disease |
| topic | Celiac Disease |
| url | https://doi.org/10.1056/NEJMoa1404172 |