Trial reportGastroenterology2022
Latiglutenase Protects the Mucosa and Attenuates Symptom Severity in Patients With Celiac Disease Exposed to a Gluten Challenge.
Trial report in Gastroenterology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03585478 (A Double-Blind, Placebo Controlled, Gluten Challenge Trial of the Efficacy, Safety and Tolerability of 6-weeks Treatment of Latiglutenase), which is not on this map. Cited by 40 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Double-Blind, Placebo Controlled, Gluten Challenge Trial of the Efficacy, Safety and Tolerability of 6-weeks Treatment of Latiglutenase (IMGX003) Administration in Patients With Well-Controlled Celiac Disease
Who cites it
40 citing papers in PubMed, 1 synthesis or guideline pooled it, 69 citations in OpenAlex.
- Gastrointestinal and Extraintestinal Symptoms Among Subjects With Celiac Disease Undergoing a Dose-Specified Gluten Challenge: A Systematic Review and Meta-Analysis.The American journal of gastroenterology · 2026Pooled it
- Trial
- Molecular histomorphometry and the emerging role of transcriptomics in celiac disease diagnosis and therapeutic trials.Annals of medicine · 2026Review
- Beyond gluten-free diet: Novel therapeutic frontiers in celiac disease armamentarium.World journal of gastrointestinal pharmacology and therapeutics · 2026Review
- Targeted enzymatic therapy for coeliac disease.EMBO molecular medicine · 2026Article
- Upcoming Treatments in Celiac Disease: From Luminal Enzymes to Oral Immune Tolerance.United European gastroenterology journal · 2026Review
- From gluten to therapeutics: molecular mechanisms of celiac disease and emerging alternatives to the gluten-free diet.Frontiers in pharmacology · 2026Review
- Review
- Proteases in intestinal health and disease.Nature reviews. Gastroenterology & hepatology · 2026Review
- Rethinking Celiac Disease Management: Treatment Approaches Beyond the Gluten-Free Diet.Biomedicines · 2025Review
- The Adaptable Binding Cleft of RmuAP1, a Pepsin-like Peptidase fromBiomolecules · 2025Article
- Comparative Effectiveness of Urine vs. Stool Gluten Immunogenic Peptides Testing for Monitoring Gluten Intake in Coeliac Patients: A Systematic Review and Meta-Analysis.Life (Basel, Switzerland) · 2025Review
- Gluten Proteins: Beneficial Factors and Toxic Triggers in Human Health.Foods (Basel, Switzerland) · 2025Review
- Is There a Future Without Gluten Restrictions for Celiac Patients? Update on Current Treatments.Nutrients · 2025Review
- New therapies in celiac disease.Current opinion in gastroenterology · 2025Review
- Coeliac disease: complications and comorbidities.Nature reviews. Gastroenterology & hepatology · 2025Review
- Review Article: Novel Enzyme Therapy Design for Gluten Peptide Digestion Through Exopeptidase Supplementation.Alimentary pharmacology & therapeutics · 2025Review
- Celiac Disease-Narrative Review on Progress in Celiac Disease.Foods (Basel, Switzerland) · 2025Review
- Is the microbiome important in celiac disease?Journal of the Canadian Association of Gastroenterology · 2025Article
- Celiac Disease: Beyond Diet and Food Awareness.Foods (Basel, Switzerland) · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 4 institutions in 2 countries.
Funding
Abstract
BACKGROUND &
aimsGluten ingestion in patients with celiac disease can lead to gastrointestinal symptoms and small intestinal mucosal injury.
methodsThis gluten challenge phase 2 trial was double blind and placebo controlled, and it assessed the efficacy and safety of a 1200-mg dose of IMGX003 in patients with celiac disease exposed to 2 g of gluten per day for 6 weeks. The change in the ratio of villus height to crypt depth was the primary endpoint. Secondary endpoints included density of intraepithelial lymphocytes and symptom severity. These endpoints were evaluated by analysis of covariance. Additional endpoints included serology and gluten-immunogenic peptides in urine.
resultsFifty patients were randomized, and 43 patients completed the study (IMGX003, n = 21; placebo, n = 22). The mean change in the ratio of villus height to crypt depth (primary endpoint) for IMGX003 vs placebo was -0.04 vs -0.35 (P = .057). The mean change in the density of intraepithelial lymphocytes (secondary endpoint) for IMGX003 vs placebo was 9.8 vs 24.8 cells/mm epithelium (P = .018). The mean change (worsening) in symptom severity in relative units (secondary endpoint) for IMGX003 vs placebo 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). The 3 × 2-week trend line significance values for these symptoms, respectively, were P = .014, .030, and .002.
conclusionsIMGX003 reduced gluten-induced intestinal mucosal damage and symptom severity. (ClinicalTrials.gov, Number: NCT03585478).
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.