This trial is active, not recruiting.

Condition non celiac gluten sensitivity
Treatments gluten, gluten free flour
Sponsor Università degli Studi di Brescia
Start date July 2012
End date March 2013
Trial size 26 participants
Trial identifier NCT01827566, GE-2012-GS


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, caregiver)
Primary purpose diagnostic
(Active Comparator)
10 grams of gluten in each sachet to be dispersed daily on food for ten days, while maintaining a gluten free diet
(Placebo Comparator)
10 grams of gluten free flour in each sachet to be dispersed daily on food for ten days, while maintaining a gluten free diet
gluten free flour

Primary Outcomes

Patient's ability to correctly identify the phase with gluten
time frame: Time (days) 35

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

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
Principal investigator Barbara Zanini, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Università degli Studi di Brescia.