Clinical trials

The following institutions are conducting studies using the iVYDAL products:

The following studies that evaluate the iVYDAL In Vitro Diagnostics® products have already been published inrecognized international scientific journals:

  1. To evaluate the determination of GIP as an indicator of adherence to a gluten-free diet:  Brunetta Porcelli et al (2020). Fecal gluten immunogenic peptides as indicators of dietary compliance in celiac patients. Minerva Gastroenteol Dietol. 2020 Sep; 66(3):201-207 DOI: 10.23736/S1121-421X.20.02662-8
  2. Study of GIPs utility as biomarkers of gluten-free diet monitoring:  Ruiz-Carnicer et al (2020). Negative predictive value of the repeated absence of gluten immunogenic peptides in the urine of treated celiac patients in predicting mucosal healing: new proposals for follow-up in celiac disease. The American Journal of Clinical Nutrition 2020;00:1-12  DOI: 10.1093/ajcn/nqaa188
  3. Evaluation of the adhesion to the gluten-free diet in celiac patients: Stefanolo et al.. Real-World Gluten Exposure in Patients With Celiac Disease on Gluten-Free Diets, Determined From Gliadin Immunogenic Peptides in Urine and Fecal Samples. Clin Gastroenterol Hepatol. 2020;0(0) DOI: 10.1016/j.cgh.2020.03.038
  4. Correlation study between the quantity of GIP detected in urine and stool samples and the synthons and atrophies in the intestine villi: Silvester et al.. Determination Of Gluten Grams Ingested and Excreted By Adults eating Gluten-Free – The “DOGGIE Bag” Study. Gastro. 2020; DOI: 10.1093/ajcn/nqx049
  5. The study of the efficiency of a new antibody to investigate the treatment of the celiac disease:  Marja-Leena et al.. Safety and efficacy of AMG 714 in adults with coeliac disease exposed to gluten challenge: a phase 2a, randomised, double-blind, placebo-controlled study. Lancet Gastroenterol Hepatol 2019 Dec;4(12):948-959. DOI: 10.1016/S2468-1253(19)30264-X
  6. Evaluation of the urine or stool GIPs to detect diet transgressions: Costa et al.. Gluten immunogenic peptide excretion detects dietary transgressions in treated celiac disease patients. World J Gastroenterol. 2019;25(11):1409-1420. DOI: 10.3748/wjg.v25.i11.1409
  7. Evaluation of the adhesion of the gluten-free diet of the celiac pediatric patients through GIP quantification in stool: Comino et al.. Prospective longitudinal study: use of faecal gluten immunogenic peptides to monitor children diagnosed with coeliac disease during transition to a gluten-free diet. Aliment Pharmacol Ther.  2019;49(12):1484-1492 DOI: 10.1111/apt.15277
  8. Study of the celiac patient predisposition to thrombosis development: Szakács et al.. Haemorheological and Haemostatic Alterations in Coeliac Disease and Inflammatory Bowel Disease in Comparison With Non-Coeliac, non-IBD Subjects (HERMES): A Case-Control Study Protocol. BMJ Open. 2019;9(3):e026315 DOI: 10.1136/bmjopen-2018-026315
  9. Diet transgressions evaluation in gluten-free patients: Syage et al.. Determination of gluten consumption in celiac disease patients on a gluten-free diet. Am J Clin Nutr. 2018;107(2):201-207  DOI: 10.1093/ajcn/nqx049
  10. Comparative study of the synthons and digestion associated with the gluten-free bread ingestion or transgenic flour bread with low gliadin in sensitive patients to gluten (NCGS): Haro et al.. The dietary intervention of transgenic low-gliadin wheat bread in patients with non-celiac gluten sensitivity (NCGS) showed no differences with gluten free diet (GFD) but provides better gut microbiota profile. Nutrients 2018;10(12) DOI: 10.3390/nu1012196
  11. Evaluation of GIP excretion in children: Coronel et al.. Influence of infant feeding on the excretion of gluten immunopeptides in feces. Rev Española Enfermedades Dig. 2018;111(2):134-139. DOI: 10.17235/reed.2018.5559/2018
  12. Correlation study of the quantity of gluten ingested and excreted in adults that follow a gluten-free diet: Silvester et al.. Determination of Gluten Grams Ingested and Excrected by Adults Eating Gluten-Free (Doggiebag). Gastroenterology. 2018;154(6):S-130. DOI: 10.1016/S0016-5085(18)30862-X
  13. Detection and quantification study of GIP in stool samples in pediatric patients and the relationship there with the diet. Roca et al.. Detection and quantification of gluten immunogenic peptides in feces of infants and their relationship with diet. Rev. Española Enfermedades Dig. 2018 Feb;111(2):106-110. DOI: 10.17235/reed.2018.5549/2018
  14. Recommendations about the parameters to be measured in clinical trials about celiac disease made by experts. They include the determination of GIP in stool and urine samples. Ludvigsson et al. Outcome measures in coeliac disease trials: the Tampere recommendations. Gut. 2018 Aug;67(8):1410-1424.
  15. Study comparing GIP determination in stool samples with other methods to follow gluten free diet adherence in celiac patients.sasGerasimidis K et al. Comparison of Clinical Methods with the Faecal Gluten Immunogenic Peptide to Assess Gluten Intake in Coeliac Disease. J Pediatr Gastroenterol Nutr. 2018 Jun 18. DOI: 10.1097/MPG.0000000000002062
  16. Review about the different markers for gluten free diet monitoring in celiac patients. Moreno et al. Biomarkers to Monitor Gluten-Free Diet Compliance in Celiac Patients. Nutrients. 2017 Jan 6;9(1). pii: E46. DOI: 10.3390/nu9010046
  17. First clinical trial evaluating the clinical utility of the determination of GIP in stool samples: Comino et al.. Fecal gluten peptides reveal limitations of serological test and food questionnaires for monitoring gluten-free diet in celiac disease patients. American Journal of Gastroenterology. 2016; 10.1038/agj.2016.439.
  18. First study using our GIP detection technology in urine samples: Moreno et al.. Detection of gluten immunogenic peptides in the urine of patients with coeliac disease reveals transgressions in the gluten-free diet and incomplete mucosal healing. Gut, (2015) gutjnl-2015-310148.
  19. First study using our GIP detection technology in stool samples: Comino et al.. Monitoring of gluten-free diet compliance in celiac patients by assessment of gliadin 33-mer equivalent epitopes in feces.  J. Clin. Nutr.2012; 95(3): 670-677. DOI: 10.3945/ajcn.111.026708
  20. First publication using antibodies specifically designed for the toxic peptide of gluten: Morón et al.. Sensitive detection of cereal fractions that are toxic to celiac disease patients by using monoclonal antibodies to a main immunogenic wheat peptide. Am. J. Clin. Nutr. 2008; 87:405-414.