Trial reportGastroenterology2021
Evaluating Responses to Gluten Challenge: A Randomized, Double-Blind, 2-Dose Gluten Challenge Trial.
Trial report in Gastroenterology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03409796 (Assessment of Immune Activation and Tolerance in Celiac Disease During Gluten Challenge), which is not on this map. Cited by 40 papers, 3 of them syntheses 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.
Assessment of Immune Activation and Tolerance in Celiac Disease During Gluten Challenge
Who cites it
40 citing papers in PubMed, 3 syntheses or guidelines pooled it, 96 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
- European Society for the Study of Coeliac Disease 2025 Updated Guidelines on the Diagnosis and Management of Coeliac Disease in Adults. Part 1: Diagnostic Approach.United European gastroenterology journal · 2025Guideline
- Systematic Review and Dose-Response Meta-Analysis on the Relationship between Different Gluten Doses and Risk of Coeliac Disease Relapse.Nutrients · 2023Pooled it
- Trial
- Effects of a gluten challenge in patients with irritable bowel syndrome: a randomized single-blind controlled clinical trial.Scientific reports · 2022Trial
- TAK-101 Nanoparticles Induce Gluten-Specific Tolerance in Celiac Disease: A Randomized, Double-Blind, Placebo-Controlled Study.Gastroenterology · 2021Trial
- The Challenges of Performing Controlled Trials of Diet Therapies in Gastroenterology.JGH open : an open access journal of gastroenterology and hepatology · 2026Review
- Functional immune profiling reveals CD4Immunology and cell biology · 2026Article
- Review
- Transcriptomics and eQTLs reveal inflammatory heterogeneity in the duodenal lining in coeliac disease.Genes and immunity · 2025Article
- Challenges in the Pediatric Celiac Disease Diagnosis: An Up-to-Date Review.Diagnostics (Basel, Switzerland) · 2025Review
- Diagnosis of celiac disease on a gluten-free diet: a multicenter prospective quasi-experimental clinical study.BMC medicine · 2025Article
- Celiac Disease and Gluten Cross-Contact: How Much is too Much?Current nutrition reports · 2025Review
- Acute gluten-induced inflammatory response highlights CCL20 as a potential biomarker for celiac disease.Frontiers in immunology · 2025Article
- An optimised whole blood interleukin-2 release assay is more sensitive than interferon-γ ELISpot for detecting and quantifying gluten-specific CD4Clinical & translational immunology · 2025Article
- Intestinal celiac disease - related autoantibodies.Frontiers in immunology · 2025Review
- Yield of Gluten Challenge in Patients on Self-Prescribed Gluten-Free Diets.Digestive diseases and sciences · 2024Article
- Article
- Evolution in coeliac disease diagnosis and management.JGH open : an open access journal of gastroenterology and hepatology · 2024Review
- New Insights on Genes, Gluten, and Immunopathogenesis of Celiac Disease.Gastroenterology · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 7 institutions in 2 countries.
Funding
Abstract
BACKGROUND &
aimsGluten challenge is used to diagnose celiac disease (CeD) and for clinical research. Sustained gluten exposure reliably induces histologic changes but is burdensome. We investigated the relative abilities of multiple biomarkers to assess disease activity induced by 2 gluten doses, and aimed to identify biomarkers to supplement or replace histology.
methodsIn this randomized, double-blind, 2-dose gluten-challenge trial conducted in 2 US centers (Boston, MA), 14 adults with biopsy-proven CeD were randomized to 3 g or 10 g gluten/d for 14 days. The study was powered to detect changes in villous height to crypt depth, and stopped at planned interim analysis on reaching this end point. Additional end points included gluten-specific cluster of differentiation (CD)4 T-cell analysis with HLA-DQ2-gluten tetramers and enzyme-linked immune absorbent spot, gut-homing CD8 T cells, interleukin-2, symptoms, video capsule endoscopy, intraepithelial leukocytes, and tissue multiplex immunofluorescence.
resultsAll assessments showed changes with gluten challenge. However, time to maximal change, change magnitude, and gluten dose-response relationship varied. Villous height to crypt depth, video capsule endoscopy enteropathy score, enzyme-linked immune absorbent spot, gut-homing CD8 T cells, intraepithelial leukocyte counts, and HLA-DQ2-restricted gluten-specific CD4 T cells showed significant changes from baseline at 10 g gluten only; symptoms were significant at 3 g. Symptoms and plasma interleukin-2 levels increased significantly or near significantly at both doses. Interleukin-2 appeared to be the earliest, most sensitive marker of acute gluten exposure.
conclusionsModern biomarkers are sensitive and responsive to gluten exposure, potentially allowing less invasive, lower-dose, shorter-duration gluten ingestion. This work provides a preliminary framework for rational design of gluten challenge for CeD research. ClinicalTrials.gov number, NCT03409796.
Indexed as
Identifiers
What OpenQuestion 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 OpenQuestion graph.