{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T00:18:40Z","timestamp":1789777120074,"version":"4.0.1"},"reference-count":33,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2012,11,19]],"date-time":"2012-11-19T00:00:00Z","timestamp":1353283200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2013,1]]},"abstract":"<jats:title>Summary<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      Coeliac disease, an autoimmune disorder triggered by gluten ingestion, is managed by a gluten\u2010free diet (\n                      <jats:styled-content style=\"fixed-case\">GFD<\/jats:styled-content>\n                      ), which is difficult for many patients. Larazotide acetate is a first\u2010in\u2010class oral peptide that prevents tight junction opening, and may reduce gluten uptake and associated sequelae.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>To evaluate the efficacy and tolerability of larazotide acetate during gluten challenge.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      This exploratory, double\u2010blind, randomised, placebo\u2010controlled study included 184 patients maintaining a\n                      <jats:styled-content style=\"fixed-case\">GFD<\/jats:styled-content>\n                      before and during the study. After a\n                      <jats:styled-content style=\"fixed-case\">GFD<\/jats:styled-content>\n                      run\u2010in, patients were randomised to larazotide acetate (1, 4, or 8\u00a0mg three times daily) or placebo and received 2.7 grams of gluten daily for 6\u00a0weeks. Outcomes included an experimental biomarker of intestinal permeability, the lactulose\u2010to\u2010mannitol (\n                      <jats:styled-content style=\"fixed-case\">LAMA<\/jats:styled-content>\n                      ) ratio and clinical symptoms assessed by Gastrointestinal Symptom Rating Scale (\n                      <jats:styled-content style=\"fixed-case\">GSRS<\/jats:styled-content>\n                      ) and anti\u2010transglutaminase antibody levels.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      No significant differences in\n                      <jats:styled-content style=\"fixed-case\">LAMA<\/jats:styled-content>\n                      ratios were observed between larazotide acetate and placebo groups. Larazotide acetate 1\u2010mg limited gluten\u2010induced symptoms measured by\n                      <jats:styled-content style=\"fixed-case\">GSRS<\/jats:styled-content>\n                      (\n                      <jats:italic>P\u00a0<\/jats:italic>\n                      =\n                      <jats:italic>\u00a0<\/jats:italic>\n                      0.002 vs. placebo). Mean ratio of anti\u2010tissue transglutaminase IgA levels over baseline was 19.0 in the placebo group compared with 5.78 (\n                      <jats:italic>P\u00a0<\/jats:italic>\n                      =\n                      <jats:italic>\u00a0<\/jats:italic>\n                      0.010), 3.88 (\n                      <jats:italic>P\u00a0<\/jats:italic>\n                      =\n                      <jats:italic>\u00a0<\/jats:italic>\n                      0.005) and 7.72 (\n                      <jats:italic>P\u00a0<\/jats:italic>\n                      =\n                      <jats:italic>\u00a0<\/jats:italic>\n                      0.025) in the larazotide acetate 1\u2010, 4\u2010, and 8\u2010mg groups, respectively. Adverse event rates were similar between larazotide acetate and placebo groups.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      Larazotide acetate reduced gluten\u2010induced immune reactivity and symptoms in patients with coeliac disease undergoing gluten challenge and was generally well tolerated; however, no significant difference in\n                      <jats:styled-content style=\"fixed-case\">LAMA<\/jats:styled-content>\n                      ratios between larazotide acetate and placebo was observed. Results and design of this exploratory study can inform the design of future studies of pharmacological interventions in patients with coeliac disease.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/apt.12147","type":"journal-article","created":{"date-parts":[[2012,11,19]],"date-time":"2012-11-19T23:35:42Z","timestamp":1353368142000},"page":"252-262","source":"Crossref","is-referenced-by-count":178,"title":["Larazotide acetate in patients with coeliac disease undergoing a gluten challenge: a randomised placebo\u2010controlled study"],"prefix":"10.1111","volume":"37","author":[{"given":"C. P.","family":"Kelly","sequence":"first","affiliation":[{"name":"Celiac Center Beth Israel Deaconess Medical Center Harvard Medical School Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P. H. R.","family":"Green","sequence":"additional","affiliation":[{"name":"Celiac Disease Center Columbia University New York NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J. A.","family":"Murray","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Mayo Clinic Rochester MN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"DiMarino","sequence":"additional","affiliation":[{"name":"Thomas Jefferson University Hospital Philadelphia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Colatrella","sequence":"additional","affiliation":[{"name":"Pittsburgh Gastroenterology Associates Pittsburgh PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D. A.","family":"Leffler","sequence":"additional","affiliation":[{"name":"Celiac Center Beth Israel Deaconess Medical Center Harvard Medical School Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T.","family":"Alexander","sequence":"additional","affiliation":[{"name":"Gastrointestinal Specialists Troy MI USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R.","family":"Arsenescu","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine University of Kentucky Lexington KY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"F.","family":"Leon","sequence":"additional","affiliation":[{"name":"Alba Therapeutics Corporation Baltimore MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J. G.","family":"Jiang","sequence":"additional","affiliation":[{"name":"Alba Therapeutics Corporation Baltimore MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L. A.","family":"Arterburn","sequence":"additional","affiliation":[{"name":"Alba Therapeutics Corporation Baltimore MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"B. M.","family":"Paterson","sequence":"additional","affiliation":[{"name":"Alba Therapeutics Corporation Baltimore MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R. N.","family":"Fedorak","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology University of Alberta Edmonton AB USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the Larazotide Acetate Celiac Disease Study Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2012,11,19]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2005.02.016"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1053\/jcgh.2003.50004"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra010852"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0002-9343(03)00302-4"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1158\/0008-5472.CAN-04-1096"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10620-007-0055-3"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.meg.0000236884.21343.e4"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1572-0241.2003.07632.x"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1093\/ajcn\/85.1.160"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1159\/000066757"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1067\/mge.2003.54"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2010.10"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2005.02.007"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1172\/JCI30253"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1136\/gut.2005.085373"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0016-5085(97)70123-9"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1203\/00006450-199804000-00001"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2036.2001.01034.x"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.febslet.2005.07.066"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.4049\/jimmunol.171.11.6164"},{"key":"e_1_2_7_22_1","doi-asserted-by":"publisher","DOI":"10.2353\/ajpath.2006.060681"},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.peptides.2012.02.015"},{"key":"e_1_2_7_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.peptides.2012.02.016"},{"key":"e_1_2_7_25_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2007.03413.x"},{"key":"e_1_2_7_26_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2012.211"},{"key":"e_1_2_7_27_1","first-page":"143","article-title":"Intestinal permeability tests in coeliac disease","volume":"47","author":"Johnston SD","year":"2001","journal-title":"Clin Lab"},{"key":"e_1_2_7_28_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF01535722"},{"key":"e_1_2_7_29_1","first-page":"170","volume-title":"Assessment of Quality of Life in Clinical Trials of Cardiovascular Therapies","author":"Dupuy H","year":"1984"},{"key":"e_1_2_7_30_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1572-0241.2001.03462.x"},{"key":"e_1_2_7_31_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2008.59"},{"key":"e_1_2_7_32_1","volume-title":"Linzess (linaclotide) prescribing information","year":"2012"},{"key":"e_1_2_7_33_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2012.254"},{"key":"e_1_2_7_34_1","first-page":"105","article-title":"Gluten\u2010free diet and quality of life in patients with screen\u2010detected celiac disease","volume":"5","author":"Mustalahti K","year":"2002","journal-title":"Eff Clin Pract"}],"container-title":["Alimentary Pharmacology &amp; Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fapt.12147","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/apt.12147","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,11,22]],"date-time":"2023-11-22T05:01:53Z","timestamp":1700629313000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/apt.12147"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2012,11,19]]},"references-count":33,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2013,1]]}},"alternative-id":["10.1111\/apt.12147"],"URL":"https:\/\/doi.org\/10.1111\/apt.12147","archive":["Portico"],"relation":{"has-review":[{"id-type":"doi","id":"10.3410\/f.717964906.793468894","asserted-by":"object"}]},"ISSN":["0269-2813","1365-2036"],"issn-type":[{"value":"0269-2813","type":"print"},{"value":"1365-2036","type":"electronic"}],"subject":[],"published":{"date-parts":[[2012,11,19]]}}}