Oral Lesions In Non-Celiac Wheat Sensitivity Patients

NCT02421809 | Completed

• 1 other identifier: ACPM09
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 2

Brief Summary

Non-celiac gluten sensitivity (NCGS) or 'wheat sensitivity' (NCWS) is included in the spectrum of gluten-related disorders. No data are available on the prevalence of oral lesions in NCWS. Our study aims to evaluate the prevalence of oral lesions in NCWS patients and search for correlations with other clinical characteristics. This prospective observation study will include 90 NCWS patients with irritable bowel syndrome (IBS)- like symptoms, 90 IBS and 90 celiac controls. Patients will be recruited at the Internal Medicine and at the Gastroenterology Units of the University of Palermo. Elimination diet and double-blind placebo controlled (DBPC) wheat challenge proved the NCWS diagnosis. All subjects underwent oral examination to assess the presence or not of oral soft and hard tissue lesions potentially associated to NCWS and CD.

Conditions

Non-celiac Wheat Sensitivity

Outcome Measures

Primary Outcomes (1)

• Change in oral lesion (composite outcome)

  All patients will undergo oral examination to assess the presence or not of oral soft and hard tissue lesions potentially associated to NCWS and CD. This study will be performed by Dental Clinics and the patients will be clinically examined by calibrated dentists. Dental caries at cavity level, fillings and extractions due to caries will be reported and the DMFT/DMFS (Decayed Missing Filled Teeth/Decay Missing Filled Surfaces) indexes will be assessed following the WHO diagnostic criteria of 1997. Enamel hypoplasia will be diagnosed according to Molar-Incisor Hypomineralisation (MIH). Calibration will be previously made on a sample of 20 subjects unless kappa values higher than 0,8 will be obtained for both caries and hypomineralisation. Attention will also be paid to patients with some other oral lesions, such as recurrent aphthous stomatitis (RAS), symmetric and systematic dental enamel defects, and non-specific atrophic glossitis.

  At baseline and after 24 months

Study Arms (3)

NCWS patients

Consecutive adult patients with an irritable bowel syndrome (IBS)-like clinical presentation, according to Rome II criteria, and a definitive diagnosis of NCWS.

CD patients

Sex- and age-matched subjects with CD, diagnosed according to standard criteria during the same study period and enrolled as first control group.

IBS patients

Sex- and age-matched subjects with IBS unrelated to NCWS or other food 'intolerance', diagnosed according to standard criteria during the same study period and enrolled as second control group.

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 study will include consecutive adult patients with irritable bowel syndrome (IBS)-like clinical presentation, according to Rome II criteria, and a definitive diagnosis of NCWS, referred at the Internal Medicine and at the Gastroenterology Units of the University Hospital of Palermo, between may 2015 and may 2017.

You may qualify if:

• To diagnose NCWS the recently proposed criteria will be adopted. All the patients will meet the following criteria:
• negative serum anti-transglutaminase (anti-tTG) and anti-endomysium (EmA) immunoglobulin (Ig)A and IgG antibodies;
• absence of intestinal villous atrophy;
• negative IgE-mediated immune-allergy tests to wheat (skin prick tests and/or serum specific IgE detection);
• resolution of the IBS symptoms on standard elimination diet, excluding wheat, cow's milk, egg, tomato, chocolate, and other self-reported food(s) causing symptoms;
• symptom reappearance on double-blind placebo-controlled (DBPC) wheat challenge. As the investigators previously described in other studies, DBPC cow's milk protein challenge and other "open" food challenges will be performed too.
• age \>18 years; follow-up duration longer than six months after the initial diagnosis;
• at least two outpatient visits during the follow-up period.

You may not qualify if:

• positive EmA in the culture medium of the duodenal biopsies, also in the case of normal villi/crypts ratio in the duodenal mucosa;
• other "organic" gastrointestinal disorders;
• nervous system disease and/or major psychiatric disorder;
• physical impairment limiting physical activity;
• menopause;
• steroid and sex steroid therapy, hormone replacement therapy or ovariectomy.

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (2)

Antonio Carroccio

Agrigento, Italy

Location

Pasquale Mansueto

Palermo, 90127, Italy

Location

Related Publications (8)

• Mansueto P, Seidita A, D'Alcamo A, Carroccio A. Role of FODMAPs in Patients With Irritable Bowel Syndrome. Nutr Clin Pract. 2015 Oct;30(5):665-82. doi: 10.1177/0884533615569886. Epub 2015 Feb 18.

  PMID: 25694210 RESULT

• Carroccio A, D'Alcamo A, Mansueto P. Nonceliac wheat sensitivity in the context of multiple food hypersensitivity: new data from confocal endomicroscopy. Gastroenterology. 2015 Mar;148(3):666-7. doi: 10.1053/j.gastro.2014.11.047. Epub 2015 Jan 24. No abstract available.

  PMID: 25625764 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

• Mansueto P, Seidita A, D'Alcamo A, Carroccio A. Non-celiac gluten sensitivity: literature review. J Am Coll Nutr. 2014;33(1):39-54. doi: 10.1080/07315724.2014.869996.

  PMID: 24533607 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

• Carroccio A, Mansueto P, D'Alcamo A, Iacono G. Non-celiac wheat sensitivity as an allergic condition: personal experience and narrative review. Am J Gastroenterol. 2013 Dec;108(12):1845-52; quiz 1853. doi: 10.1038/ajg.2013.353. Epub 2013 Nov 5.

  PMID: 24169272 RESULT

• Carroccio A, Brusca I, Mansueto P, D'alcamo A, Barrale M, Soresi M, Seidita A, La Chiusa SM, Iacono G, Sprini D. A comparison between two different in vitro basophil activation tests for gluten- and cow's milk protein sensitivity in irritable bowel syndrome (IBS)-like patients. Clin Chem Lab Med. 2013 Jun;51(6):1257-63. doi: 10.1515/cclm-2012-0609.

  PMID: 23183757 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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsy specimens will be obtained from the bulb and the second duodenal portion.

Study Officials

• Antonio Carroccio, PhD

  Department of Internal Medicine, Giovanni Paolo II Hospital, Via Pompei, Sciacca, Italy

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: April 21, 2015
• Study Start: May 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: June 1, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

IT (2)