Abdominal Ultrasound Examination in Non-celiac Wheat Sensitivity

Non-celiac Wheat Sensitivity Clinical Trial

Official title:

Abdominal Ultrasound Examination in Patients Affected With Non-celiac Wheat Sensitivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03017274
• Other study ID #: ACPM20
• Status: Completed
• Phase: N/A
• First received: December 30, 2016
• Last updated: January 9, 2017
• Start date: January 2015
• Est. completion date: November 2016

Study information

• Verified date: January 2017
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypersensitivity
• Non-celiac Wheat Sensitivity

Intervention

Other:
• Abdominal ultrasound examination
All subjects undergone abdominal ultrasonography at the Outpatient of Ultrasonography of the Department of Internal Medicine at the University Hospital of Palermo, Italy.

Locations

Country	Name	City	State
Italy	Department of Internal Medicine, University Hospital of Palermo	Palermo
Italy	Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca	Sciacca	Agrigento

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. — View Citation

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. A — View Citation

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. — View Citation

Carroccio A, Soresi M, D'Alcamo A, Sciumè 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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Soresi M, Pirrone G, Giannitrapani L, Iacono G, Di Prima L, La Spada E, Di Fede G, Ambrosiano G, Montalto G, Carroccio A. A key role for abdominal ultrasound examination in "difficult" diagnoses of celiac disease. Ultraschall Med. 2011 Jan;32 Suppl 1:S53- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal ultrasonographic features of NCWS and CD patients	Evaluation of abdominal ultrasonographic differences between NCWS and CD patients.	from January 2015 to November 2016	Yes