Larazotide acetate in patients with coeliac disease undergoing a gluten challenge: A randomised placebo-controlled study

Alimentary Pharmacology and Therapeutics

Volumn 37, Issue 2, 2013, Pages 252-262

  Kelly, C P ^a   Green, P H R ^b   Murray, J A ^c   Dimarino, A ^d   Colatrella, A ^e   Leffler, D A ^a   Alexander, T ^f   Arsenescu, R ^g   Leon, F ^h   Jiang, J G ^h   Arterburn, L A ^h   Paterson, B M ^h   Fedorak, R N ⁱ  

^a HARVARD MEDICAL SCHOOL   (United States)

^b Och Spine at New York Presbyterian Hospitals   (United States)

^c MAYO CLINIC   (United States)

^d THOMAS JEFFERSON UNIVERSITY HOSPITAL   (United States)

^e Associates in Gastroenterology   (United States)

^f Gastrointestinal Specialists   (United States)

^g UNIVERSITY OF KENTUCKY   (United States)

^h Alba Therapeutics Corporation   (United States)

ⁱ UNIVERSITY OF ALBERTA   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

IMMUNOGLOBULIN A ANTIBODY; LARAZOTIDE; PLACEBO; PROTEIN GLUTAMINE GAMMA GLUTAMYLTRANSFERASE ANTIBODY;

ABDOMINAL DISTENSION; ABDOMINAL PAIN; ADULT; AGED; ARTICLE; CELIAC DISEASE; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DIGESTIVE TRACT PARAMETERS; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG TOLERABILITY; DRUG WITHDRAWAL; EXPLORATORY RESEARCH; FATIGUE; FEMALE; FLATULENCE; GASTROINTESTINAL DISEASE; GASTROINTESTINAL SYMPTOM RATING SCALE; GLUTEN FREE DIET; HUMAN; INTESTINE MUCOSA PERMEABILITY; LACTULOSE TO MANNITOL RATIO; MAJOR CLINICAL STUDY; MALE; NAUSEA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; SIDE EFFECT; SINGLE BLIND PROCEDURE;

EID: 84872717725     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/apt.12147     Document Type: Article

References (33)

1. Green PH,. The many faces of celiac disease: clinical presentation of celiac disease in the adult population. Gastroenterology 2005; 128: S74-8.
2. Murray JA, Van Dyke C, Plevak MF, et al,. Trends in the identification and clinical features of celiac disease in a North American community, 1950-2001. Clin Gastroenterol Hepatol 2003; 1: 19-27.
3. Farrell RJ, Kelly CP,. Celiac sprue. N Engl J Med 2002; 346: 180-8.
4. Green PH, Fleischauer AT, Bhagat G, et al,. Risk of malignancy in patients with celiac disease. Am J Med 2003; 115: 191-5.
5. Potter DD, Murray JA, Donohue JH, et al,. The role of defective mismatch repair in small bowel adenocarcinoma in celiac disease. Cancer Res 2004; 64: 7073-7.
6. Leffler DA, Edwards-George J, Dennis M, et al,. Factors that influence adherence to a gluten-free diet in adults with celiac disease. Dig Dis Sci 2008; 53: 1573-81.
7. Gibert A, Espadaler M, Angel Canela M, et al,. Consumption of gluten-free products: should the threshold value for trace amounts of gluten be at 20, 100 or 200 p.p.m.? Eur J Gastroenterol Hepatol 2006; 18: 1187-95.
8. Midhagen G, Hallert C,. High rate of gastrointestinal symptoms in celiac patients living on a gluten-free diet: controlled study. Am J Gastroenterol 2003; 98: 2023-6.
9. Catassi C, Fabiani E, Iacono G, et al,. A prospective, double-blind, placebo-controlled trial to establish a safe gluten threshold for patients with celiac disease. Am J Clin Nutr 2007; 85: 160-6.
10. Ciacci C, Cirillo M, Cavallaro R, et al,. Long-term follow-up of celiac adults on gluten-free diet: prevalence and correlates of intestinal damage. Digestion 2002; 66: 178-85.
11. Lee SK, Lo W, Memeo L, et al,. Duodenal histology in patients with celiac disease after treatment with a gluten-free diet. Gastrointest Endosc 2003; 57: 187-91.
12. Rubio-Tapia A, Rahim MW, See JA, et al,. Mucosal recovery and mortality in adults with celiac disease after treatment with a gluten-free diet. Am J Gastroenterol 2010; 105: 1412-20.
13. NIH. National institutes of health consensus development conference statement on celiac disease, June 28-30, 2004. Gastroenterology 2005; 128: S1-9.
14. Kagnoff MF,. Celiac disease: pathogenesis of a model immunogenetic disease. J Clin Invest 2007; 117: 41-9.
15. Arrieta MC, Bistritz L, Meddings JB,. Alterations in intestinal permeability. Gut 2006; 55: 1512-20.
16. Smecuol E, Bai JC, Vazquez H, et al,. Gastrointestinal permeability in celiac disease. Gastroenterology 1997; 112: 1129-36.
17. Schulzke JD, Bentzel CJ, Schulzke I, et al,. Epithelial tight junction structure in the jejunum of children with acute and treated celiac sprue. Pediatr Res 1998; 43: 435-41.
18. Vogelsang H, Schwarzenhofer M, Steiner B, et al,. In vivo and in vitro permeability in coeliac disease. Aliment Pharmacol Ther 2001; 15: 1417-25.
19. Sander GR, Cummins AG, Henshall T, et al,. Rapid disruption of intestinal barrier function by gliadin involves altered expression of apical junctional proteins. FEBS Lett 2005; 579: 4851-5.
20. Bruewer M, Luegering A, Kucharzik T, et al,. Proinflammatory cytokines disrupt epithelial barrier function by apoptosis-independent mechanisms. J Immunol 2003; 171: 6164-72.
21. Turner JR,. Molecular basis of epithelial barrier regulation: from basic mechanisms to clinical application. Am J Pathol 2006; 169: 1901-9.
22. Gopalakrishnan S, Durai M, Kitchens K, et al,. Larazotide acetate regulates epithelial tight junctions in vitro and in vivo. Peptides 2012; 35: 86-94.
23. Gopalakrishnan S, Tripathi A, Tamiz AP, et al,. Larazotide acetate promotes tight junction assembly in epithelial cells. Peptides 2012; 35: 95-101.
24. Paterson BM, Lammers KM, Arrieta MC, et al,. The safety, tolerance, pharmacokinetic and pharmacodynamic effects of single doses of AT-1001 in coeliac disease subjects: a proof of concept study. Aliment Pharmacol Ther 2007; 26: 757-66.
25. Leffler DA, Kelly CP, Zamil HA, et al,. A randomized, double-blind study of larazotide acetate to prevent the activation of celiac disease during gluten challenge. Am J Gastroenterol 2012; 107: 1554-62.
26. Johnston SD, Smye M, Watson RP,. Intestinal permeability tests in coeliac disease. Clin Lab 2001; 47: 143-50.
27. Svedlund J, Sjodin I, Dotevall G,. GSRS a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci 1988; 33: 129-34.
28. Dupuy H,. The Psychological General Well-Being (PGWB) Index. In:, Wenger N, Mattson M, Furberg C, et al., eds. Assessment of Quality of Life in Clinical Trials of Cardiovascular Therapies. New York: Le Jacq Publishing, 1984; 170-83.
29. Green PHR, Stavropoulos SN, Panagi SG, et al,. Characteristics of adult celiac disease in the USA: results of a national survey. Am J Gastroenterol 2001; 96: 126-31.
30. Johnston JM, Kurtz CB, Drossman DA, et al,. Pilot study on the effect of linaclotide in patients with chronic constipation. Am J Gastroeneterol 2009; 104: 125-32.
31. Linzess (linaclotide) prescribing information. Cambridge, MA: Ironwood Pharmaceuticals, Inc., 2012.
32. Chey WD, Lembo AJ, Lavins BJ, et al,. Linaclotide for irritable bowel syndrome with constipation: a 26-week, randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety. Am J Gastroenterol 2012; doi: 10.1038/ajg.2012.254 [Epub ahead of print].
33. Mustalahti K, Lohiniemi S, Collin P, et al,. Gluten-free diet and quality of life in patients with screen-detected celiac disease. Eff Clin Pract 2002; 5: 105-13.