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| ID | Type | Description | Link |
|---|---|---|---|
| 1876 | Other Identifier | Fondazione IRCCS CÃ Granda |
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Non Celiac Gluten Sensitivity (NCGS) is an emergent syndrome mainly inducing gastrointestinal symptoms. NCGS is suspected to be present in the 6% of the population and thus it represents an important issue in health care. Actually it remains difficult to diagnose and prove due to the lack of established criteria. The investigators intention is to establish a diagnostic flowchart to evaluate the real impact of NCGS in a cohort of patients suffering from functional gastrointestinal symptoms.
The proposed study has been designed to be a randomised double-blind multicenter clinical trial with crossover. The Coordinating Center will be the "Centro per la Prevenzione e la Diagnosi della Malattia Celiaca", Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Milano. Secondary enrollment centers will be Italian Gastroenterology Units with outpatient services. Enrollment criteria will be diagnosis of irritable bowel syndrome (IBS) or functional dyspepsia. Patients with other functional gastrointestinal disorders will be included in the group "Functional non specific gastrointestinal symptoms".
After they give their written informed consent, patients will undergo the diagnostic work-up recommended in case of suspected irritable bowel symptoms/functional dyspepsia and aimed at the exclusion of CD or allergy to alimentary antigens by means of serological testing (anti transglutaminase antibodies) or skin tests, or other gastrointestinal diseases. Endoscopic, histologic and/or imaging exams together with supplemental blood tests will be prescribed on individual cases and according with the international guidelines.
Enrolled subjects will be asked to fill
At the end of the present phase patients will start a GFD for the subsequent three weeks.
At the end of the GFD period patients will fill VAS and SF36. Only those patients presenting a 30% increase of the global VAS score ("GFD Responders") will continue the study. Conversely, non responders will be considered "non gluten sensitive" and they will finish the trial.
Responders to the GFD period will entry the randomisation phase and will undergo a double-blind stimulation test with cross over. Patients will be randomised to assume gluten or placebo for 7 days. After the treatment patients will fill VAS and SF36.
A diagnosis of NCGS will be ascertained in case of symptomatic response limited to gluten ingestion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| suspected NC gluten sensitive subjects | Experimental | Patients referring gastrointestinal functional disorders will be selected and they will follow a gluten free diet |
|
| suspected NC gluten sensitive | Experimental | Patients referring gastrointestinal functional disorders will be selected and they will follow a gluten free diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gluten | Dietary Supplement | The enrolled patients will be invited to follow a gluten free diet. Patients responsive to the diet will be invited to assume gluten or placebo following a double blind with cross over scheme |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores on the Visual Analogue Scales | Symptomatic resolution after the instauration of a gluten free diet will be verified by means of VAS scales | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | patients with non celiac gluten sensitivity will be evaluated by means of SF36 questionnaire | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luca Elli, MD, PhD | Center for Prevention and Diagnosis of Celiac Disease, Fondazione IRCCS CÃ Granda | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Maggiore di Crema | Crema | Italy | 26013 | Italy | ||
| Ospedale S. Maria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35973395 | Derived | Scricciolo A, Lombardo V, Elli L, Bascunan KA, Doneda L, Rinaldi F, Pinto D, Araya M, Costantino A, Vecchi M, Roncoroni L. Use of a proline-specific endopeptidase to reintroduce gluten in patients with non-coeliac gluten sensitivity: A randomized trial. Clin Nutr. 2022 Sep;41(9):2025-2030. doi: 10.1016/j.clnu.2022.07.029. Epub 2022 Jul 31. |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D005983 | Glutens |
| ID | Term |
|---|---|
| D055315 | Prolamins |
| D000078522 | Grain Proteins |
| D010940 | Plant Proteins |
| D011506 | Proteins |
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| Placebo | Dietary Supplement | Patients responsive to the diet will be invited to blindly assume gluten or placebo following a double blind with cross over scheme |
|
| Feltre |
| Italy |
| 32032 |
| Italy |
| Ospedale Di Busto Arsizio | Busto Arsizio | Lombardy | Italy |
| Ospedale Valduce di Como | Como | Lombardy | Italy |
| Arcispedale S. Maria Nuova | Reggio Emilia | 42122 | Italy |
| D004066 | Digestive System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D055314 | Seed Storage Proteins |