Trial reportNutrients2016
Evidence for the Presence of Non-Celiac Gluten Sensitivity in Patients with Functional Gastrointestinal Symptoms: Results from a Multicenter Randomized Double-Blind Placebo-Controlled Gluten Challenge.
Trial report in Nutrients, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 84 papers, 6 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
84 citing papers in PubMed, 6 syntheses or guidelines pooled it, 186 citations in OpenAlex.
- Guideline
- Exclusion Diets in Functional Dyspepsia.Nutrients · 2022Pooled it
- Predefined Diets in Patients with Inflammatory Bowel Disease: Systematic Review and Meta-Analysis.Nutrients · 2020Pooled it
- Irritable Bowel Syndrome and Gluten-Related Disorders.Nutrients · 2020Pooled it
- Efficacy of the gluten free diet in the management of functional gastrointestinal disorders: a systematic review on behalf of the Italian Society of Paediatrics.Italian journal of pediatrics · 2019Pooled it
- Mood Disorders and Gluten: It's Not All in Your Mind! A Systematic Review with Meta-Analysis.Nutrients · 2018Pooled it
- Trial
- No Difference in Tolerance between Wheat and Spelt Bread in Patients with Suspected Non-Celiac Wheat Sensitivity.Nutrients · 2022Trial
- The effect of gluten in adolescents and young adults with gastrointestinal symptoms: a blinded randomised cross-over trial.Alimentary pharmacology & therapeutics · 2022Trial
- Trial
- Prevalence of Non-Celiac Gluten Sensitivity in Patients with Refractory Functional Dyspepsia: a Randomized Double-blind Placebo Controlled Trial.Scientific reports · 2020Trial
- Trial
- Exposure to Different Amounts of Dietary Gluten in Patients with Non-Celiac Gluten Sensitivity (NCGS): An Exploratory Study.Nutrients · 2019Trial
- Trial
- Randomized Double-Blind Placebo-Controlled Crossover Trial for the Diagnosis of Non-Celiac Gluten Sensitivity in Children.The American journal of gastroenterology · 2018Trial
- Trial
- Review
- Article
- S1 Guideline of the German Society for Neurogastroenterology and Motility (DGNM) on Functional Dyspepsia (FD), a Disorder of Gut-Brain Interaction (DGBI) [English Language Edition].Gastroenterology research and practice · 2026Review
- Next-Generation Therapies for Gastrointestinal Repair: Converging Traditional Medicine and Tissue Engineering.JGH open : an open access journal of gastroenterology and hepatology · 2025Review
24 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
26 authors at 15 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Non-celiac gluten sensitivity (NCGS) is characterized by the onset of symptoms after eating gluten-containing food. We aimed to single out NCGS subjects among subjects with functional gastrointestinal symptoms. Patients were enrolled in a multicenter double-blind placebo-controlled trial with crossover. Symptoms and quality of life were evaluated by means of 10-cm VAS and SF36. Iron parameters, transaminases and C reactive protein (CRP) were evaluated. After a three-week-long gluten-free diet (GFD), responsive patients were randomly assigned to gluten intake (5.6 g/day) or placebo for seven days, followed by crossover. The primary endpoint was the worsening of symptoms (VAS increase ≥3 cm) during gluten ingestion compared to placebo. One hundred and forty patients were enrolled and 134 (17 males, mean age 39.1 ± 11.7 years, BMI 22.4 ± 3.8) completed the first period. A total of 101 subjects (10 males, mean age 39.3 ± 11.0 years, BMI 22.3 ± 4.0) reported a symptomatic improvement (VAS score 2.3 ± 1.2 vs. 6.5 ± 2.2 before and after GFD, p = 0.001). 98 patients underwent the gluten challenge and 28 (all females, mean age 38.9 ± 12.7 years, BMI 22.0 ± 2.9) reported a symptomatic relapse and deterioration of quality of life. No parameters were found to be statistically associated with positivity to the challenge. However, 14 patients responded to the placebo ingestion. Taking into account this finding, about 14% of patients responding to gluten withdrawal showed a symptomatic relapse during the gluten challenge. This group is suspected to have NCGS.
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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.