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Status:

COMPLETED

Extraintestinal Non Celiac Wheat Sensitivity

Lead Sponsor:

University of Palermo

Conditions:

Non-celiac Gluten Sensitivity

Eligibility:

All Genders

18-65 years

Brief Summary

Non Celiac Gluten Sensitivity (NCGS), or, better, Non Celiac Wheat Sensitivity (NCWS), since it is not known the real pathogenetic component(s) of grain, is a syndrome characterized by a cohort of sym...

Detailed Description

Non Celiac Gluten Sensitivity (NCGS), or, better, Non Celiac Wheat Sensitivity (NCWS), since it is not known the real pathogenetic component(s) of grain, is a syndrome characterized by a cohort of sym...

Eligibility Criteria

Inclusion

  • NCWS
  • NCWS was diagnosed after CD or WA had been ruled out in all the studied patients according to the following criteria:
  • (1) negative serum assays for serum CD-anti-tissue transglutaminase (anti-tTG) immunoglobulin (Ig) A and anti-deamidated gliadin peptide (anti-DGP) IgG antibodies; (2) absence of intestinal villous atrophy, documented in all the patients carrying the DQ2 and/or the DQ8 HLA haplotypes (thus irrespective of CD-specific serum antibody negativity), evaluated when patients had a minimum intake of 100 g of wheat daily since at least 2 weeks; (3) negative IgE-mediated immune-allergy tests to wheat (skin prick tests and/or specific serum IgE detection); (4) resolution of symptoms on a standard elimination diet, without wheat, cow's milk, yeast, and other food(s) causing self-reported symptoms, followed by symptom reappearance on a DBPC wheat challenge. Additional inclusion criteria were: age older than 18 years, follow-up duration longer than 12 months after the initial diagnosis, and at least 2 outpatient visits during the follow-up period.
  • NCWS

Exclusion

  • (1) positive anti-endomysial antibodies (EmA) in the culture medium of the duodenal biopsies, also in the case of normal villi/crypts ratio in the duodenal mucosa; (2) self-exclusion of wheat from the diet and refusal to reintroduce it before entering the study; (3) other previously diagnosed gastrointestinal disorders; (4) nervous system disease and/or major psychiatric disorder; (5) physical impairment limiting physical activity.
  • CD Inclusion Criteria:
  • (1) positive serum anti-tTG and EmA IgA and IgG antibodies; (2) presence of intestinal villous atrophy.
  • CD

Key Trial Info

Start Date :

January 1 2000

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

January 1 2021

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT04769180

Start Date

January 1 2000

End Date

January 1 2021

Last Update

February 24 2021

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Internal Medicine Division of the "Cervello-Villa Sofia" Hospital

Palermo, PA, Italy, 90146

2

Department of Internal Medicine, University Hospital of Palermo

Palermo, Italy, 90127