Prevalence of Non Celiac Gluten Sensitivity Among Patients Spontaneously Adherent to Gluten Free Diet

Study Overview
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Brief Summary
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The purpose of this study is to assess the prevalence of Gluten Sensitivity, by a double-blind placebo-controlled challenge with gluten, followed by two months period of Low-FODMAPs (Fermentable Oligosaccharides Disaccharides Monosaccharides And Polyols) diet, in patients spontaneously adherent to gluten free diet because of symptoms upon gluten exposure and in whom diagnosis of Celiac Disease and Wheat Allergy has been ruled out.

Official Title
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Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial With a Cross-over Design to Assess the Prevalence of Non Celiac Gluten Sensitivity Among Patients Spontaneously Adherent to Gluten Free Diet

Conditions
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Non Celiac Gluten Sensitivity

Intervention / Treatment
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* Other: gluten
* Other: gluten free flour


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adherence to gluten free diet without medical need Negative Celiac Disease related serology (while on gluten containing diet) Normal villous structure at duodenal biopsy (while on gluten containing diet) Exclusion Criteria: Diagnosis of Celiac Disease Diagnosis of Wheat Allergy Diagnosis of organic gastrointestinal disease Severe concomitant disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: gluten<br>10 grams of gluten in each sachet to be dispersed daily on food for ten days, while maintaining a gluten free diet | Other: gluten<br> <br> |
| Placebo Comparator: gluten free flour<br>10 grams of gluten free flour in each sachet to be dispersed daily on food for ten days, while maintaining a gluten free diet | Other: gluten free flour<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's ability to correctly identify the phase with gluten | time 0: start of first challenge (phase A, either with gluten or gluten free flour) time 10: end of phase A and start of wash-out period time 25: end of wash-out period and start of second challenge (phase B, either with gluten or gluten free flour) time 35: end of phase B | Time (days) 35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in serum level of anti-tissue transglutaminases immunoglobulin A (IgA)/immunoglobulin G (IgG) and of anti-gliadin IgA/IgG | time 0: start of first challenge (phase A, either with gluten or gluten free flour) time 10: end of phase A and start of wash-out period time 25: end of wash-out period and start of second challenge (phase B, either with gluten or gluten free flour) time 35: end of phase B | Time (days) 0, 10, 25, 35 | 
| Change in Fatigue Visual Scale | time 0: start of first challenge (phase A, either with gluten or gluten free flour) time 10: end of phase A and start of wash-out period time 25: end of wash-out period and start of second challenge (phase B, either with gluten or gluten free flour) time 35: end of phase B | Time (days) 0, 10, 25, 35 | 
| Change in Gastrointestinal Rating Score (GSRS) during Challenge with and without gluten | Time 0: Start of first challenge (phase A, either with gluten or gluten free flour) Time 10: end of phase A and start of wash-out period Time 25: end of wash-out period and start of second challenge (phase B, either with gluten or gluten free flour) Time 35: end of phase B At the beginning of Low-FODMAPs diet After two months of Low-FODMAPs diet | Time (days) 0,10, 25, 35 | 
| Change in symptoms' score (1 to 7 Likert scale) as recorded on a daily diary | time 0: start of first challenge (phase A, either with gluten or gluten free flour) time 10: end of phase A and start of wash-out period time 25: end of wash-out period and start of second challenge (phase B, either with gluten or gluten free flour) time 35: end of phase B | From Time 0 (days) to 10 and from 25 to 35 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Celiac Disease, Gluten Sensitivity, Gluten, Double-blind challenge, placebo-controlled challenge, Gluten free flour