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

Not Applicable

• Conditions: Non Celiac Gluten Sensitivity
• Interventions: Other: gluten; Other: gluten free flour

• Registration Number: NCT01827566
• Lead Sponsor: Università degli Studi di Brescia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2013-03
• Study First Submitted: 2013-04-04
• Study First Submitted QC: 2013-04-08
• Study First Posted: 2013-04-09
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-05
• Last Update Posted: 2014-12-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
gluten	gluten	10 grams of gluten in each sachet to be dispersed daily on food for ten days, while maintaining a gluten free diet
gluten free flour	gluten free flour	10 grams of gluten free flour in each sachet to be dispersed daily on food for ten days, while maintaining a gluten free diet

Primary Outcome Measures

Name	Time	Method
Patient's ability to correctly identify the phase with gluten	Time (days) 35	* 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

Secondary Outcome Measures

Name	Time	Method
Change in symptoms' score (1 to 7 Likert scale) as recorded on a daily diary	From Time 0 (days) to 10 and from 25 to 35	* 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
Changes in serum level of anti-tissue transglutaminases immunoglobulin A (IgA)/immunoglobulin G (IgG) and of anti-gliadin IgA/IgG	Time (days) 0, 10, 25, 35	* 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
Change in Gastrointestinal Rating Score (GSRS) during Challenge with and without gluten	Time (days) 0,10, 25, 35	* 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
Change in Fatigue Visual Scale	Time (days) 0, 10, 25, 35	* 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

Trial Locations

Locations (1)

University and Spedali Civili of Brescia, Unit of Gastroenterology; 🇮🇹 Brescia, Italy