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

• Sponsor: Università degli Studi di Brescia (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01827566
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arms: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non Celiac Gluten Sensitivity	Other: gluten; Other: gluten free flour	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Diagnostic
• Official Title: 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
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Mar 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University and Spedali Civili of Brescia, Unit of Gastroenterology	Brescia		Italy	I-25123

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alberto Lanzini, MD PhD, Associate Professor of Gastroenterology, Università degli Studi di Brescia
• ClinicalTrials.gov Identifier: NCT01827566
• Other Study ID Numbers: GE-2012-GS
• First Posted: Apr 9, 2013
• Last Update Posted: Dec 8, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by Alberto Lanzini, MD PhD, Associate Professor of Gastroenterology, Università degli Studi di Brescia: Celiac Disease; Gluten Sensitivity; Gluten; Double-blind challenge, placebo-controlled challenge; Gluten free flour
• Additional relevant MeSH terms: Hypersensitivity

Study Results

No Results Posted as of Dec 8, 2014