Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gluten | Active Comparator | 10 grams of gluten in each sachet to be dispersed daily on food for ten days, while maintaining a gluten free diet |
|
| gluten free flour | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gluten | Other |
| ||
| gluten free flour |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's ability to correctly identify the phase with gluten |
| Time (days) 35 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in serum level of anti-tissue transglutaminases immunoglobulin A (IgA)/immunoglobulin G (IgG) and of anti-gliadin IgA/IgG |
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alberto Lanzini, MD, PhD | University of Brescia, Unit of Gastroenterology | Study Chair |
| Barbara Zanini, MD, PhD | University of Brescia, Unit of Gastroenterology | Principal Investigator |
| Chiara Ricci, MD, PhD | University of Brescia, Unit of Gastroenterology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University and Spedali Civili of Brescia, Unit of Gastroenterology | Brescia | I-25123 | Italy |
Not provided
| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005983 | Glutens |
| ID | Term |
|---|---|
| D055315 | Prolamins |
| D000078522 | Grain Proteins |
| D010940 | Plant Proteins |
| D011506 | Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Time (days) 0, 10, 25, 35 |
| Change in Fatigue Visual Scale |
| Time (days) 0, 10, 25, 35 |
| Change in Gastrointestinal Rating Score (GSRS) during Challenge with and without gluten |
| Time (days) 0,10, 25, 35 |
| 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 |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D055314 | Seed Storage Proteins |