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001-es BibID:BIBFORM048562
Első szerző:Tack, Greetje J.
Cím:Consumption of gluten with gluten-degrading enzyme by celiac patients : a pilot-study / Greetje J. Tack, Jolanda M. W. van de Water, Maaike J. Bruins, Engelina M. C. Kooy-Winkelaar, Jeroen van Bergen, Petra Bonnet, Anita C. E. Vreugdenhil, Ilma Korponay-Szabo, Luppo Edens, B. Mary E. von Blomberg, Marco W. J. Schreurs, Chris J. Mulder, Frits Koning
Dátum:2013
ISSN:1007-9327
Megjegyzések:AIM:To assesses the safety and efficacy of Aspergillus niger prolyl endoprotease (AN-PEP) to mitigate the immunogenic effects of gluten in celiac patients.METHODS:Patients with initial diagnosis of celiac disease as confirmed by positive serology with subtotal or total villous atrophy on duodenal biopsies who adhere to a strict gluten-free diet (GFD) resulting in normalised antibodies and mucosal healing classified as Marsh 0 or I were included. In a randomised double-blind placebo-controlled pilot study, patients consumed toast (approximately 7 g/d gluten) with AN-PEP for 2 wk (safety phase). After a 2-wk washout period with adherence of the usual GFD, 14 patients were randomised to gluten intake with either AN-PEP or placebo for 2 wk (efficacy phase). Measurements at baseline included complaints, quality-of-life, serum antibodies, immunophenotyping of T-cells and duodenal mucosa immunohistology. Furthermore, serum and quality of life questionnaires were collected during and after the safety, washout and efficacy phase. Duodenal biopsies were collected after the safety phase and after the efficacy phase. A change in histological evaluation according to the modified Marsh classification was the primary endpoint.RESULTS:In total, 16 adults were enrolled in the study. No serious adverse events occurred during the trial and no patients withdrew during the trial. The mean score for the gastrointestinal subcategory of the celiac disease quality (CDQ) was relatively high throughout the study, indicating that AN-PEP was well tolerated. In the efficacy phase, the CDQ scores of patients consuming gluten with placebo or gluten with AN-PEP did not significantly deteriorate and moreover no differences between the groups were observed. During the efficacy phase, neither the placebo nor the AN-PEP group developed significant antibody titers. The IgA-EM concentrations remained negative in both groups. Two patients were excluded from entering the efficacy phase as their mucosa showed an increase of two Marsh steps after the safety phase, yet with undetectable serum antibodies, while 14 patients were considered histologically stable on gluten with AN-PEP. Also after the efficacy phase, no significant deterioration was observed regarding immunohistological and flow cytometric evaluation in the group consuming placebo compared to the group receiving AN-PEP. Furthermore, IgA-tTG deposit staining increased after 2 wk of gluten compared to baseline in four out of seven patients on placebo. In the seven patients receiving AN-PEP, one patient showed increased and one showed decreased IgA-tTG deposits.CONCLUSION:AN-PEP appears to be well tolerated. However, the primary endpoint was not met due to lack of clinical deterioration upon placebo, impeding an effect of AN-PEP.
Tárgyszavak:Orvostudományok Elméleti orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Adverse events
Aspergillus niger prolyl endoprotease
Celiac disease
Enzyme
IgA-tTG intestinal deposits
Prolyl endoprotease
Megjelenés:World Journal of Gastroenterology 19 : 35 (2013), p. 5837-5847. -
További szerzők:Water, Jolanda M. W. van de Bruins, Maaike J. Kooy-Winkelaar, Engelina M. C. Bergen, Jeroen van Bonnet, Petra Vreugdenhil, Anita C. E. Korponay-Szabó Ilma (1959-) (gyermekgyógyász) Edens, Luppo Blomberg, B. Mary E. von Schreurs, Marco W. J. Mulder, Chris J. Koning, Frits
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001-es BibID:BIBFORM056540
Első szerző:Vriezinga, Sabine Lisa
Cím:Randomized feeding intervention in infants at high risk for celiac disease / S. L. Vriezinga, R. Auricchio, E. Bravi, G. Castillejo, A. Chmielewska, P. Crespo Escobar, S. Kolaček, S. Koletzko, I. R. Korponay-Szabo, E. Mummert, I. Polanco, H. Putter, C. Ribes-Koninckx, R. Shamir, H. Szajewska, K. Werkstetter, L. Greco, J. Gyimesi, C. Hartman, C. Hogen Esch, E. Hopman, A. Ivarsson, T. Koltai, F. Koning, E. Martinez-Ojinaga, C. te Marvelde, A. Mocic Pavic, J. Romanos, E. Stoopman, V. Villanacci, C. Wijmenga, R. Troncone, M. L. Mearin
Dátum:2014
ISSN:0028-4793
Megjegyzések:BACKGROUND 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. METHODS We performed a multicenter, randomized, double-blind, placebo-controlled dietaryintervention study involving 944 children who were positive for HLA-DQ2 or HLADQ8 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. RESULTS 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. CONCLUSIONS 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.)
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:New England Journal Of Medicine 371 : 14 (2014), p. 1304-1315. -
További szerzők:Auricchio, Renata Bravi, Enzo (biológus) Castillejo, Gemma (gyermekgyógyász, gasztroenterológus) Chmielewska, Anna Crespo-Escobar, Paula Kolaček, Sanja Koletzko, Sibylle Korponay-Szabó Ilma (1959-) (gyermekgyógyász) Mummert, Eckart Polanco, Isabel Putter, Hein Ribes-Koninckx, Carmen Shamir, Raanan (gyermekgyógyász) Szajewska, Hania (gyermekgyógyász) Werkstetter, Katharina (gyermekgyógyász, gasztroenterológus) Greco, Luigi Gyimesi Judit Hartman, Corina Hogen Esch, Caroline Hopman, Erica Ivarsson, Anneli Koltai Tünde Koning, Frits Martinez-Ojinaga, Eva Marvelde, Chantal te Pavic, Ana Romanos, Jihane Stoopman, Els Villanacci, Vincenzo Wijmenga, Cisca Troncone, Riccardo Mearin, Maria Luisa
Pályázati támogatás:TÁMOP-2.2.11/1/KONV-2012-0023
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101788
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