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

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

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 Overview

• Status: Unknown
• Conditions: Non Celiac Gluten Sensitivity
• Intervention / Treatment: Other: gluten; Other: gluten free flour

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Brescia, Italy, I-25123
    • University and Spedali Civili of Brescia, Unit of Gastroenterology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: gluten; 10 grams of gluten in each sachet to be dispersed daily on food for ten days, while maintaining a gluten free diet	Other: gluten
PLACEBO_COMPARATOR: 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	Other: gluten free flour

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Università degli Studi di Brescia
• Investigators: Study Chair: Alberto Lanzini, MD, PhD, University of Brescia, Unit of Gastroenterology; Principal Investigator: Barbara Zanini, MD, PhD, University of Brescia, Unit of Gastroenterology; Principal Investigator: Chiara Ricci, MD, PhD, University of Brescia, Unit of Gastroenterology

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: April 4, 2013
• First Submitted That Met QC Criteria: April 8, 2013
• First Posted (ESTIMATE): April 9, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 8, 2014
• Last Update Submitted That Met QC Criteria: December 5, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Gluten; Celiac Disease; Gluten Sensitivity; Double-blind challenge, placebo-controlled challenge; Gluten free flour
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: GE-2012-GS