Extraintestinal Non Celiac Wheat Sensitivity

NCT04769180 | Completed

• 1 other identifier: ACPM27
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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 symptoms, both gastrointestinal and extraintestinal, related to the ingestion of gluten/wheat-containing food in subjects who are not affected by celiac disease (CD) or wheat allergy. In particular, the possibility of extraintestinal manifestations in this condition has been suggested by some reports. In most cases, they are characterized by vague symptoms, such as headache, 'foggy mind', fatigue, joint and muscle pain, leg or arm numbness (i.e., fibromyalgia-like symptoms), even if more specific complaints have been described. A possible neurological involvement has been underlined by NCWS association with gluten encephalopathy, gluten ataxia, and gluten peripheric neuropathy. NCWS patients may show even psychiatric diseases, such as anxiety, depression, and psychosis. Other described extraintestinal manifestations are dermatitis, (eczema or skin rash), gynecological disorders, and anemia. In addition, the association of NCWS with autoimmune diseases, such as autoimmune thyroiditis, and presence of anti-nuclear or other autoantibodies has been demonstrated, suggesting that, similarly to CD, NCWS might be considered as an immune system-related disease, and this aspect should be of relevance. In conclusion, the novelty of this matter has generated an expansion of literature data about the clinical features of the disease, with the unavoidable consequence that some reports are often based on low levels of evidence. The aims of the present study were to: a) retrospectively evaluate the prevalence and kind of extraintestinal symptoms in a large cohort of NCWS patients; b) to research for a possible relationship between the clinical, serological, genetic and histological characteristics of the NCWS patients and the number and kind of extraintestinal manifestations. As control groups, the researchers used CD and Irritable Bowel Syndrome (IBS) patients unrelated to NCWS or other food allergies/intolerances.

Conditions

Non-celiac Gluten Sensitivity

Keywords

Non-celiac Gluten Sensitivity; Celiac Disease; Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (3)

• Evaluation of extraintestinal symptoms in NCWS patients

  Evaluation of systemic (malaise, fatigue), dermatological (eczema or skin rash), neurological (headache, 'foggy mind', gluten encephalopathy, gluten ataxia, gluten peripheric neuropathy, leg or arm numbness), psychiatric (anxiety, depression, psychosis), musculoskeletal (joint and muscle pain), gynaecological, and hematological (anemia) symptoms in NCWS patients.

  Up to 15 years

• Evaluation of extraintestinal symptoms in CD patients

  Evaluation of systemic (malaise, fatigue), dermatological (eczema or skin rash), neurological (headache, 'foggy mind', gluten encephalopathy, gluten ataxia, gluten peripheric neuropathy, leg or arm numbness), psychiatric (anxiety, depression, psychosis), musculoskeletal (joint and muscle pain), gynaecological, and hematological (anemia) symptoms in CD patients.

  Up to 15 years

• Evaluation of extraintestinal symptoms in IBS patients unrelated to NCWS or other food allergies/intolerances.

  Evaluation of systemic (malaise, fatigue), dermatological (eczema or skin rash), neurological (headache, 'foggy mind', gluten encephalopathy, gluten ataxia, gluten peripheric neuropathy, leg or arm numbness), psychiatric (anxiety, depression, psychosis), musculoskeletal (joint and muscle pain), gynaecological, and hematological (anemia) symptoms in IBS patients unrelated to NCWS or other food allergies/intolerances.

  Up to 15 years

Study Arms (3)

Patients affected with NCWS

100 patients with a definitive diagnosis of NCWS, based on DBPC gluten/wheat challenge.

Other: Evaluation of extraintestinal manifestations

Patients affected with CD

50 patients affected with CD, sex- (± 5%) and age-matched (± 2 years) with the NCWS patients, selected at random during the study period.

Other: Evaluation of extraintestinal manifestations

Patients affected with IBS not related to NCWS or other food allergies/intolerances

50 patients affected with IBS, according to the Rome IV criteria, not related to NCWS or other food allergies/intolerances, sex- (± 5%) and age-matched (± 2 years) with the NCWS patients, selected at random during the study period.

Other: Evaluation of extraintestinal manifestations

Interventions

Evaluation of extraintestinal manifestations OTHER

The researchers evaluated the prevalence and kind of extraintestinal symptoms in NCWS patients and the possible relationship between the clinical, serological, genetic and histological characteristics of the NCWS patients and the number and kind of extraintestinal manifestations, using, as control groups, CD and IBS patients.

Also known as: Extraintestinal manifestations

Patients affected with CD; Patients affected with IBS not related to NCWS or other food allergies/intolerances; Patients affected with NCWS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The researchers evaluated the extraintestinal manifestations in 3 groups of patients: (1) 100 patients with a definitive diagnosis of NCWS, based on DBPC gluten/wheat challenge; (2) 50 patients affected with CD, sex- (± 5%) and age-matched (± 2 years) with the NCWS patients, selected at random during the study period; (3) 50 patients affected with IBS, according to the Rome IV criteria, not related to NCWS or other food allergies/intolerances, sex- (± 5%) and age-matched (± 2 years) with the NCWS patients, selected at random during the study period.

You may qualify if:

• NCWS was diagnosed after CD or WA had been ruled out in all the studied patients according to the following criteria:

You may not qualify if:

• (1) positive serum anti-tTG and EmA IgA and IgG antibodies; (2) presence of intestinal villous atrophy.

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (2)

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

Palermo, PA, 90146, Italy

Location

Department of Internal Medicine, University Hospital of Palermo

Palermo, 90127, Italy

Location

Related Publications (7)

• Mansueto P, Soresi M, Candore G, Garlisi C, Fayer F, Gambino CM, La Blasca F, Seidita A, D'Alcamo A, Lo Sasso B, Florena AM, Geraci G, Caio G, Volta U, De Giorgio R, Ciaccio M, Carroccio A. Autoimmunity Features in Patients With Non-Celiac Wheat Sensitivity. Am J Gastroenterol. 2021 May 1;116(5):1015-1023. doi: 10.14309/ajg.0000000000000919.

  PMID: 33009065 RESULT

• Soresi M, Incandela S, Mansueto P, Incandela G, La Blasca F, Fayer F, D'Alcamo A, Florena AM, Carroccio A. Gynecological Disorders in Patients with Non-celiac Wheat Sensitivity. Dig Dis Sci. 2021 Jan;66(1):167-174. doi: 10.1007/s10620-020-06184-8. Epub 2020 Mar 7.

  PMID: 32146601 RESULT

• Mansueto P, Soresi M, La Blasca F, Fayer F, D'Alcamo A, Carroccio A. Body Mass Index and Associated Clinical Variables in Patients with Non-Celiac Wheat Sensitivity. Nutrients. 2019 May 29;11(6):1220. doi: 10.3390/nu11061220.

  PMID: 31146428 RESULT

• Carroccio A, Mansueto P, Iacono G, Soresi M, D'Alcamo A, Cavataio F, Brusca I, Florena AM, Ambrosiano G, Seidita A, Pirrone G, Rini GB. Non-celiac wheat sensitivity diagnosed by double-blind placebo-controlled challenge: exploring a new clinical entity. Am J Gastroenterol. 2012 Dec;107(12):1898-906; quiz 1907. doi: 10.1038/ajg.2012.236. Epub 2012 Jul 24.

  PMID: 22825366 RESULT

• Carroccio A, Giambalvo O, Blasca F, Iacobucci R, D'Alcamo A, Mansueto P. Self-Reported Non-Celiac Wheat Sensitivity in High School Students: Demographic and Clinical Characteristics. Nutrients. 2017 Jul 19;9(7):771. doi: 10.3390/nu9070771.

  PMID: 28753927 RESULT

• Carroccio A, Soresi M, D'Alcamo A, Sciume C, Iacono G, Geraci G, Brusca I, Seidita A, Adragna F, Carta M, Mansueto P. Risk of low bone mineral density and low body mass index in patients with non-celiac wheat-sensitivity: a prospective observation study. BMC Med. 2014 Nov 28;12:230. doi: 10.1186/s12916-014-0230-2.

  PMID: 25430806 RESULT

• Carroccio A, Rini G, Mansueto P. Non-celiac wheat sensitivity is a more appropriate label than non-celiac gluten sensitivity. Gastroenterology. 2014 Jan;146(1):320-1. doi: 10.1053/j.gastro.2013.08.061. Epub 2013 Nov 22. No abstract available.

  PMID: 24275240 RESULT

MeSH Terms

Conditions

Celiac Disease; Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Colonic Diseases, Functional; Colonic Diseases

Study Officials

• Antonio Carroccio, MD

  University of Palermo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2021
• First Posted: February 24, 2021
• Study Start: January 1, 2000
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2021
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)