Nonceliac gluten sensivity Digestive System
Conditions
Interventions
Patients will be asked to fill in a daily questionnaire in order to assess a rating scale of both intestinal and extraintestinal symptoms over a 5-week period. Participants will be asked to follow a s
Sponsors
St. Matteo Hospital Foundation (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients referred to our outpatients? clinics because of persistence of relevant intestinal and extraintestinal symptoms believed by them to be caused by the ingestion of food containing even low doses of gluten. 2. Under gluten-containing diet at the time of screening since at least two months 3. Happy to undergo ad hoc screening, including: 3.a. Serum determination of IgA anti-transglutaminase and anti-endomysial antibodies 3.b. IgG anti-gliadin antibodies (AGA) 3.c. Total IgA and IgE 3.d. Wheat-specific IgE 3.e. Upper endoscopy with collection of multiple duodenal biopsies 3.f. HLA genotyping 3.g. Fecal calprotectin 3.h. Lactose breath test
Exclusion criteria
Exclusion criteria: 1. Other significant gastrointestinal diseases, such as inflammatory bowel disease or cirrhosis, 2. Other clinically significant comorbidities such as diabetes, use of nonsteroidal anti-inflammatory agents or systemic immunomodulators 3. Pregnancy 4. Inability to give written informed consent 5. Reported psychiatric disorder 6. Excessive alcohol intake Only patients, who at the end of the screening are found not to be affected by celiac disease, wheat allergy, lactose or FODMAP intolerance, Helicobacter pylori infection, giardiasis, and who complain of relevant gluten-dependent symptoms that is affecting the overall quality of life, will be randomized according to a computer-generated list of random numbers held by an independent observer to either the gluten or the placebo treatment group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the change in the weekly overall symptom score, as assessed by the sum of intestinal and extraintestinal scores, between the 1-week treatment with gluten and the 1-week treatment with placebo. The 15 intestinal symptoms, which patients will be asked to grade daily from 0 to 3 (0=absent; 1=mild; 2=relevant, 3=severe and interfering with daily activities) are: 1. Abdominal pain 2. Abdominal bloating 3. Wind 4. Diarrhea 5. Borborygmus 6. Reduced consistency of stools 7. Increased consistency of stools 8. Constipation 9. Urgency 10. Incomplete evacuation 11. Nausea 12. Heartburn 13. Belching 14. Acid regurgitation 15. Epigastric pain. The 13 extraintestinal symptoms, which patients will be asked to grade daily from 0 (absent) to 1 (present), are: 1. Tiredness 2. Malaise 3. Headache 4. Depression 5. Anxiety 6. Foggy mind 7. Aphthous stomatitis 8. Paresthesia 9. Arthralgia 10. Myalgia 11. Asthma 12. Rhinitis 13. Skin rash | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are: 1. The change in individual symptom scores between the 1-week treatment with gluten and the 1-week treatment with placebo 2. The identification of patients with true NCGS 3. To verify whether laboratory parameters at baseline are predictive of true NCGS. True NCGS patients are defined as having at the end of the trial a delta overall score - calculated by subtracting the weekly overall score under placebo from the weekly overall score under gluten- higher than the mean delta overall score plus two standard deviations. Laboratory predictors include serum IgG AGA, fecal calprotectin, HLA genotyping and intraepithelial lymphocyte density. | — |
Countries
Italy
Outcome results
None listed