NCT01827566 - Prevalence of Non Celiac Gluten Sensitivity Among Patients Spontaneously Adherent to Gluten Free Diet | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

26

Conditions

Non Celiac Gluten Sensitivity

Interventions

glutenOTHER

gluten free flourOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University and Spedali Civili of Brescia, Unit of Gastroenterology

Brescia, Italy

Outcomes

Primary Outcomes

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 frame: Time (days) 35

Secondary Outcomes

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 frame: 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 frame: 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 frame: 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