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

Non Celiac Gluten Sensitivity Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01827566
• Other study ID #: GE-2012-GS
• Status: Active, not recruiting
• Phase: N/A
• First received: April 4, 2013
• Last updated: December 5, 2014
• Start date: July 2012

Study information

• Verified date: December 2014
• Source: Università degli Studi di Brescia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Non Celiac Gluten Sensitivity

Intervention

Other:
• gluten

• gluten free flour

Locations

Country	Name	City	State
Italy	University and Spedali Civili of Brescia, Unit of Gastroenterology	Brescia

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Brescia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	No