Non Celiac Gluten Sensitivity
Conditions
Keywords
Celiac Disease, Gluten Sensitivity, Gluten, Double-blind challenge, placebo-controlled challenge, Gluten free flour
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.
Interventions
OTHERgluten
OTHERgluten free flour
Sponsors
Università degli Studi di Brescia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Italy
Outcome results
None listed