Oral Lesions In Non-Celiac Wheat Sensitivity Patients

Completed

• Conditions: Non-celiac Wheat Sensitivity

• Registration Number: NCT02421809
• Lead Sponsor: University of Palermo

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.

Detailed Description

Celiac disease (CD) has been reported to increase the risk of oral lesions. More recently, it has been reported that a consistent percentage of the general population consider themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though they do not have CD or wheat allergy. This clinical condition has been named Non-Celiac Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the term 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat causes the symptoms in NCGS patients, and the investigators also showed that these patients had a high frequency of coexistent multiple food hypersensitivity. That previous study also showed a percentage of NCWS patients had weight loss and anemia: whether these depended on the intestinal malabsorption or not remains unclear. As yet no data are available on the presence and prevalence of oral lesions in NCWS patients. The aims of the present study is: 1) to investigate the presence and prevalence of oral lesions in NCWS patient and 2) to search for a possible correlation between oral lesions and other clinical characteristics of NCWS patients.

Study Timeline

• Study First Submitted: 2015-04-08
• Study First Submitted QC: 2015-04-15
• Study First Posted: 2015-04-21
• Study Start: 2015-05-01
• Primary Completion: 2016-10-01
• Study Completion: 2020-06-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-07
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

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.

Additional inclusion criteria will be:

• age >18 years; follow-up duration longer than six months after the initial diagnosis;
• at least two outpatient visits during the follow-up period.

Exclusion Criteria

• positive EmA in the culture medium of the duodenal biopsies, also in the case of normal villi/crypts ratio in the duodenal mucosa;
• self-exclusion of wheat from the diet and refusal to reintroduce it, before entering the study;
• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in oral lesion (composite outcome)	At baseline and after 24 months	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.

Trial Locations

Locations (2)

Pasquale Mansueto; 🇮🇹 Palermo, Italy

Antonio Carroccio; 🇮🇹 Agrigento, Italy