CompletedNot Applicable

Duodenal and Rectal Histology in Non-celiac Wheat Sensitivity and Irritable Bowel Syndrome Patients

Italy80 participantsStarted 2016-01

Plain-language summary

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. Nowadays only few data are available on the histological characteristic of duodenal and rectal biopsies of NCWS patients. The researchers have just demonstrated a significant eosinophils infiltration of the duodenal and colon mucosa, and a significant infiltration of CD45+/CD3-CD14- cells in the rectal mucosa of NCWS patients upon wheat challenge, thus configuring a diffuse gastrointestinal "inflammatory/immunologic" pattern. The aims of the present study are: 1) to investigate the histological characteristics in duodenal and rectal biopsies between NCWS and irritable bowel syndrome (IBS) patients, and 2) to evaluate which site (i.e. duodenal or rectal) shows "inflammatory/allergic" features useful for NCWS histological diagnosis.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. To diagnose IBS the standard Rome II (for retrospective patients) and Rome III (for prospective patients) Criteria will be adopted. None of these subjects improved on an elimination diet without wheat, cow's milk, egg, tomato, or chocolate. Exclusion Criteria: NCWS diagnosis will be excluded by: * 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 previously diagnosed gastrointestinal disorders * other previously diagnosed gynaecological disorders * nervous system disease and/or major psychiatric disorder * …

What they're measuring

Histological differences in duodenal biopsies between NCWS and IBS patients.

Timeframe: July 2016 to February 2017

Histological differences in rectal biopsies between NCWS and IBS patients.

Timeframe: July 2016 to February 2017

Trial details

NCT IDNCT03022994

SponsorUniversity of Palermo

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-01