- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02421809
Oral Lesions In Non-Celiac Wheat Sensitivity Patients
7. oktober 2020 oppdatert av: Pasquale Mansueto, University of Palermo
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.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
270
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Agrigento, Italia
- Antonio Carroccio
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Palermo, Italia, 90127
- Pasquale Mansueto
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Case-Control
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
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NCWS pasienter
Påfølgende voksne pasienter med irritabel tarmsyndrom (IBS)-lignende klinisk presentasjon, i henhold til Roma II-kriterier, og en definitiv diagnose av NCWS.
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CD-pasienter
Kjønns- og alderstilpassede forsøkspersoner med CD, diagnostisert i henhold til standardkriterier i samme studieperiode og registrert som første kontrollgruppe.
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IBS pasienter
Kjønns- og alderstilpassede personer med IBS som ikke er relatert til NCWS eller annen "matintoleranse", diagnostisert i henhold til standardkriterier i samme studieperiode og registrert som andre kontrollgruppe.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change in oral lesion (composite outcome)
Tidsramme: At baseline and after 24 months
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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.
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At baseline and after 24 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Antonio Carroccio, PhD, Department of Internal Medicine, Giovanni Paolo II Hospital, Via Pompei, Sciacca, Italy
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mai 2015
Primær fullføring (Faktiske)
1. oktober 2016
Studiet fullført (Faktiske)
1. juni 2020
Datoer for studieregistrering
Først innsendt
8. april 2015
Først innsendt som oppfylte QC-kriteriene
15. april 2015
Først lagt ut (Anslag)
21. april 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. oktober 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. oktober 2020
Sist bekreftet
1. oktober 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ACPM09
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