Non-Celiac Wheat Sensitivity: Permanent or Transient Condition? A Follow-up Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

Non-Celiac Gluten Sensitivity (NCGS) has been recently included among the gluten-related diseases. Patients suffering from NCGS are diagnosed after carefully excluding celiac disease (CD), and immunoglobulin E (IgE)-mediated wheat allergy. Then, in the absence of sensitive and specific diagnostic biomarkers for NCGS, a monitoring of the patient during elimination and re-introduction of wheat by a double-blind placebo controlled (DBPC) challenge method has been suggested as diagnostic hallmark. Some studies seem to suggest that wheat components other than gluten can cause the symptoms, and therefore the term non-celiac wheat sensitivity (NCWS) has been proposed instead of NCGS. While it is well known that CD is a long-life condition and a strict adherence to the gluten-free diet must be maintained, it is unknown whether this is valid for NCWS. On the year 2012, the researchers published a retrospective study, including 276 patients with irritable bowel syndrome (IBS)-like symptoms who had been diagnosed with NCWS using a DBPC challenge during a ten-years period (2001-2011). The present prospective study aimed to evaluate: A) how many of these patients are still following a wheat-free diet, and B) which percentage was still suffering from NCWS, diagnosed by DBPC wheat challenge, in a subgroup of that cohort.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Patients previously diagnosed with NCWS by DBPC challenge.

Locations
Other Locations
Italy
Department of Internal Medicine, University Hospital of Palermo
RECRUITING
Palermo
Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca
RECRUITING
Sciacca
Contact Information
Primary
Antonio Carroccio, MD
acarroccio@hotmail.com
Time Frame
Start Date: 2016-07
Estimated Completion Date: 2025-12
Participants
Target number of participants: 280
Sponsors
Leads: University of Palermo

This content was sourced from clinicaltrials.gov