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

Università degli Studi di Brescia

Status: Unknown

Conditions: Non Celiac Gluten Sensitivity

Treatments: Other: gluten; Other: gluten free flour

Study type: Interventional

Funder types: Other

Identifiers

NCT01827566

GE-2012-GS

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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26 participants in 2 patient groups, including a placebo group

gluten

Active Comparator group

Description:

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

Treatment:

Other: gluten

gluten free flour

Placebo Comparator group

Description:

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

Treatment:

Other: gluten free flour