Abdominal Ultrasound Examination in Non-celiac Wheat Sensitivity

University of Palermo

Status: Completed

Conditions: Non-celiac Wheat Sensitivity

Treatments: Other: Abdominal ultrasound examination

Study type: Observational

Funder types: Other

Identifiers

NCT03017274

ACPM20

Details and patient eligibility

About

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 no data are available on the abdominal ultrasonographic features of NCWS patients. Therefore, the aim of the present study is to evaluate the abdominal ultrasonographic features of NCWS patients in comparison with patients affected with celiac disease.

Full 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). The researchers have just demonstrated in patients affected with seronegative celiac disease that the presence of dilated bowel loops and a thickened small bowel wall had a sensitivity of 83% and a negative predictive value of 95% in CD diagnosis. Considering the presence of one of these two signs, abdominal US sensitivity increased to 92% and negative predictive value to 98%. Nowadays no data are available on the abdominal ultrasonographic features of NCWS patients. Therefore, the aim of the present study is to evaluate the abdominal ultrasonographic features of NCWS patients in comparison with patients affected with celiac disease.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 CD the standard criteria will be adopted. All the patients will meet the following criteria:

• positive serum anti-transglutaminase (anti-tTG) and anti-endomysium (EmA) immunoglobulin (Ig)A and IgG antibodies
• presence of intestinal villous atrophy.

Exclusion criteria

NCWS diagnosis excluded patients with:

• 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
• nervous system disease and/or major psychiatric disorder
• physical impairment limiting physical activity.

Trial design

100 participants in 2 patient groups

NCWS patients

Description:

Fifty consecutive adult patients with an IBS-like clinical presentation, according to Rome III criteria, and a definitive diagnosis of NCWS. The patients was recruited between January 2015 and November 2016 at 2 centers: the Department of Internal Medicine at the University Hospital of Palermo, Italy, and the Department of Internal Medicine of the Hospital of Sciacca, Agrigento, Italy. All subjects undergone abdominal ultrasonography at the Outpatient of Ultrasonography of the Department of Internal Medicine at the University Hospital of Palermo, Italy.

Treatment:

Other: Abdominal ultrasound examination

CD control patients

Description:

To compare the abdominal ultrasonographic features of NCWS patients, a control group of CD patients was randomly chosen by a computer-generated method from subjects diagnosed during the same period and age- and sex-matched with the NCWS patients. All subjects undergone abdominal ultrasonography at the Outpatient of Ultrasonography of the Department of Internal Medicine at the University Hospital of Palermo, Italy.

Treatment:

Other: Abdominal ultrasound examination