Duodenal and Rectal Histology in Non-celiac Wheat Sensitivity and Irritable Bowel Syndrome Patients
Condition: Non-celiac Wheat Sensitivity
MeSH terms: Irritable Bowel Syndrome; Hypersensitivity
Study type: Observational

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.
    

Detailed description: 
      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. The clinical picture of NCWS is
      characterized by combined gastrointestinal (bloating, abdominal pain, diarrhea and/or
      constipation, nausea, epigastric pain, gastroesophageal reflux, aphthous stomatitis) and
      extra-intestinal and/or systemic manifestations (headache, depression, anxiety, 'foggy mind,'
      tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm numbness,
      and anemia). 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. As
      regard to rectal lymphocytes, analysis of cytokine production demonstrated dominant
      spontaneous interferon (IFN)-γ production by these cells, which were further identified as
      innate lymphoid cells belonging to the group 1 (ILC1) population, expressing T-bet and
      producing IFN-γ, compatible to an innate immunity involvement in NCWS pathogenesis.
      Therefore, the aims of the present study are: 1) to investigate the histological
      characteristics and differences in duodenal and rectal biopsies between NCWS and IBS
      patients, and 2) to search for "inflammatory/allergic" features (i.e. eosinophils and/or
      lymphocytes infiltration) useful for NCWS histological diagnosis.
    

Intervention name(s): Duodenum and rectum examination
Intervention type(s): Other
Intervention description(s): All subjects will undergo upper gastrointestinal endoscopy and proctoscopy. In addition, it will be also evaluated duodenal and rectal biopsies.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study will include consecutive adult patients with IBS-like clinical presentation,
        according to Rome III criteria, and a definitive diagnosis of NCWS, referred at the
        Department of Internal Medicine at the University Hospital of Palermo, Italy, and at the
        Department of Internal Medicine of the Hospital of Sciacca, Agrigento, Italy, between July
        2016 to February 2017, and sex- and age-matched subjects with IBS, enrolled at the same
        centers, as controls patients. All subjects will undergo upper gastrointestinal endoscopy
        and proctoscopy at the Gastroenterology Unit at the University Hospital of Palermo.
        Duodenal and rectal biopsies will be evaluated at 2 centers: the Pathology Unit at the
        University Hospital of Palermo, Italy, and the Institute of Pathology, Spedali Civili
        Brescia, Brescia, Italy.
      
Biospecimen description: 
      Biopsy specimens obtained from the bulb and the second duodenal portion and the rectum.
    
Keywords: Non-celiac wheat sensitivity; eosinophils; lymphocytes; duodenal biopsies; rectal biopsies