Non-Celiac Wheat Sensitivity: Permanent or Transient Condition?

NCT ID: NCT02823522

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 280 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2025-12-31

Brief 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.

Detailed Description

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) diagnosis by negative CD-specific serum antibodies and absence of intestinal villi atrophy, and excluding IgE-mediated wheat allergy, by negative serum specific IgE and/or skin prick test with wheat antigens. 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. Obviously, this a cumbersome and time-consuming procedure which has been used in few studies.

Despite an increasing percentage of the general population define themselves as "gluten-sensitive", and by the year 2017 the market of the gluten-free products will be worth 6.6 billion of dollars, doubts persist about many aspects of NCGS. 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. Furthermore, 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 the persistence of the NCWS condition in that cohort and, consequently, the researchers estimated : 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.

Conditions

Non-Celiac Wheat Sensitivity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Patients recruitment

Between July and November 2016, the patients included in the previous retrospective study were contacted by phone, mail and e-mail and invited to come back to the respective clinics where they had been initially diagnosed as NCWS patients: the Department of Internal Medicine of the University Hospital of Palermo and the Department of Internal Medicine of the Hospital of Sciacca (province of Agrigento).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients previously diagnosed with NCWS by DBPC challenge.

Exclusion Criteria

• The 22 patients, included in the previous study, who tested positives for anti-endomysial antibodies (EmA) in the culture medium of the duodenal biopsies, even if the villi/crypts ratio in the duodenal mucosa was normal, were excluded from the present study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Palermo

OTHER

Sponsor Role: lead

Responsible Party

Pasquale Mansueto

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Carroccio, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca

Locations

Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca

Sciacca, Agrigento, Italy

Site Status: RECRUITING

Department of Internal Medicine, University Hospital of Palermo

Palermo, Palermo, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Antonio Carroccio, MD

Role: CONTACT

acarroccio@hotmail.com

Facility Contacts

Antonio Carroccio, MD, PhD

Role: primary

acarroccio@hotmail.com

+390916554347

Pasquale Mansueto, MD

Role: primary

pasquale.mansueto@unipa.it

+390916554347

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 25583468 (View on PubMed)

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Reference Type: BACKGROUND

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Carroccio A, D'Alcamo A, Iacono G, Soresi M, Iacobucci R, Arini A, Geraci G, Fayer F, Cavataio F, La Blasca F, Florena AM, Mansueto P. Persistence of Nonceliac Wheat Sensitivity, Based on Long-term Follow-up. Gastroenterology. 2017 Jul;153(1):56-58.e3. doi: 10.1053/j.gastro.2017.03.034. Epub 2017 Mar 30.

Reference Type: DERIVED

PMID: 28365444 (View on PubMed)

Other Identifiers

ACPM11

Identifier Type: -

Identifier Source: org_study_id