USA: In patients with celiac disease exposed to a gluten challenge, latiglutenase shields the mucosa and lessens symptom severity, states a study published in the official journal of the AGA Institute, Gastroenterology.
Growing numbers of people are empirically experimenting with a gluten-free diet for a range of indications and symptoms as the prevalence of gluten-related diseases rises. A unique genetic genotype and autoantibodies are the hallmarks of the gluten-induced immune-mediated enteropathy known as celiac disease. Patients with celiac disease (CeD) who consume gluten run the risk of developing gastrointestinal symptoms and small intestinal mucosal damage.

The researchers of the study evaluated the effectiveness and safety of latiglutenase administration in Celiac disease patients who underwent a gluten challenge.
In this double-blind, placebo-controlled gluten challenge (GC) Phase 2 trial, patients with CeD who were exposed to 2 g of gluten per day for 6 weeks received a dosage of 1,200 mg of IMGX003. 50 subjects were randomized. The main endpoint was the alteration in the villus height to crypt depth (Vh:Cd) ratio. Densities of intraepithelial lymphocytes (IEL) and the severity of the symptoms were secondary outcomes. ANCOVA was used to examine these endpoints. Serology and gluten-immunogenic peptides (GIP) in urine were additional outcomes.
Key findings of the research:
IMGX003 and placebo had a mean Vh:Cd of -0.04 and -0.35, respectively (p =.057).
IMGX003's mean IEL (secondary endpoint) was 9.8 vs. 24.8 (p =.018) compared to placebo.
For IMGX003 vs. placebo, the mean change (worsening) in symptom severity was 0.22 vs. 1.63 (abdominal pain; p =.231), 0.96 vs. 3.29 (bloating; p =.204), and 0.02 vs. 3.20 (tiredness; p =.113). p =.014,.030, and.002 were the respective 3 x 2-week trend-line significant values for these symptoms.
The authors concluded by saying that when people with celiac disease are exposed to gluten, latiglutenase enzyme supplementation has the potential to prevent histological damage and celiac disease symptoms.
REFERENCE
Murray JA, Syage JA, Wu TT, Dickason MA, Ramos AG, Van Dyke C, Horwath I, Lavin PT, Mäki M, Hujoel I, Papadakis KA, Bledsoe AC, Khosla C, Sealey-Voyksner JA; CeliacShield Study Group. Latiglutenase Protects the Mucosa and Attenuates Symptom Severity in Patients with Celiac Disease Exposed to a Gluten Challenge. Gastroenterology. 2022 Aug 2:S0016-5085(22)00901-5. doi: 10.1053/j.gastro.2022.07.071. Epub ahead of print. PMID: 35931103.