Test33 kit allows patients to self-test for non-celiac gluten sensitivity

CHICAGO — The Test33 kit effectively identified non-celiac gluten sensitivity among patients with compatible symptoms through a self-administered blind gluten challenge, according to results of a study presented at Digestive Disease Week.

“Today, we have no reliable biomarker to perform a diagnosis to support clinician diagnosis of NCGS. We all know food challenge is difficult to use every day in the clinical practice as they can be difficult [to design], you need individual personnel and they are time consuming,” Luca Elli, MD, PhD, from the Center for Prevention and Diagnosis of Celiac Disease, Milano, Italy

“Our aim has been to develop a self-administered, commercially available challenge to support clinicians and patients in the diagnosis of NCGS.”

The Test33 kit (Fondazione IRCCS Ca 'Granda) includes indistinguishable gluten and placebo capsules identifiable through a unique code associated with a mobile application for android or iOS. The application provides a unique guide for the patient to follow, including administration of the number of capsules, the sequence of intake and evaluation of symptoms with a visual-analog scale of 33 points, which includes 23 extraintestinal symptoms and 10 intestinal symptoms.

The study presented comprised 69 patients, randomized to take either 5.6 g of rice starch-based gluten per day or placebo for 7 days, followed by washout and crossover. Mean patient age was 38 years and 55 were women. Approximately 91% of the patients completed the challenge.

Gastrointestinal symptoms worsened among the patients taking gluten compared with the patients taking placebo, including mean results of abdominal pain (3.1 vs. 2.2), constipation (3.3 vs. 2.4), meteorism (4.9 vs. 3.8) and bloating (4.2 vs. 28). Similarly, extraintestinal symptoms worsened among the gluten group compared with the placebo group in cases of joint pain (3.3 vs. 2.5) and muscular pain (2.8 vs. 1.9).

Six women met the criteria for non-celiac gluten sensitivity diagnosis, in which 13 of the 33 VAS points were significantly worsened after gluten ingestion compared with 6 of 33 points reported by the rest of the cohort.

“The challenge results should be judged by an expert physician or a specialist indicated related disorders. Because it is self-administered, does not mean self-diagnosis,” Elli said. “The main issue of this kind of test, of gluten challenge ... is the interpretation of the test, because it depends on the criteria that we use and we still need to verify our criteria.” – by Talitha Bennett

References:

Elli L, et al. Abstract 129. Presented at: Digestive Disease Week; May 6-9, 2017; Chicago.

Disclosure : Elli reports he receives royalties from Prodeco.