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Clinical Trials


Overview of the clinical studies that performance evaluate Biomedal In Vitro Diagnostics products


DELIAC 01/2012 Multicenter study (Spain) – Published results

The study consisted of the performance evaluation of products for monitoring diet compliance in food intolerance cases by the detection of food peptides in stool samples, and new serological markers both for diagnostics and diet follow up.
One of the main objectives of the study was to directly quantify gluten immunogenic peptides (GIP) in stool samples as a marker of the gluten-free diet (GFD). The main analytical variables, such as diagnostic sensitivity and specificity, were also established. The clinical study was prospective, non-randomized, open-label and multicenter.

CADER 02/2012 Multicenter study (Spain)

Diet and villous atrophy persistence in celiac disease (CD) patients treated with GFD were evaluated in a prospective and multicenter study comparing pediatric and adult populations.
The main aim of the study was the comparison of villous atrophy persistence at 2 years after initiating a GFD in CD-diagnosed patients. The GFD adherence rate influences on the clinical state, serological markers and histology will also be studied. Finally, the percentage of CD patients that are non-responsive to GFD and the persistence of refractory celiac disease will be studied.

Thomas Jefferson University (US)

Patients with Celiac Disease (CD) can have symptoms while on a gluten free diet, and current non-invasive markers of celiac disease are lacking. This prospective, randomized, controlled trial seeks to compare a variety of non-invasive markers in patients with CD who are exposed to gluten.

Hardvard University (US)

Study of gut mucosa healing in celiac patients following a gluten free diet. The iVYDAL kits are being used in this study as an direct, objective method to control adherence to the gluten free diet.

CELIMMUNE Multicenter study (US, France, Netherlands, Spain, Finland)

Celimmune has initiated two Phase 2 studies of the AMG 714 monoclonal antibody for the treatment of diet non-responsive celiac disease and RCD-II, an in situ small bowel T cell lymphoma. The iVYDAL kits are being used in this study as an direct, objective method to control adherence to the gluten free diet.

Hospital Bonorino Udaondo (Argentina)

The main objective of the study is to establish the relationship between gluten intake and the persistence of symptoms in celiac patients following a GFD for more than 2 years. It will compare the fecal excretion of GIP (gluten immunogenic peptides) in patients with and without gastrointestinal symptoms. Moreover, the life quality will be studied in these groups and the fermentable oligo-, di-, monosaccharides and polyols (FODMAPs) role on symptoms persistence will be estimated.