Abdominal Ultrasound Examination in Non-celiac Wheat Sensitivity

NCT03017274 | Completed

• 1 other identifier: ACPM20
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Non-celiac Wheat Sensitivity

Keywords

Non-celiac wheat sensitivity; celiac disease; abdominal ultrasonography;

Outcome Measures

Primary Outcomes (1)

• Abdominal ultrasonographic features of NCWS and CD patients

  Evaluation of abdominal ultrasonographic differences between NCWS and CD patients.

  from January 2015 to November 2016

Study Arms (2)

NCWS patients

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.

Other: Abdominal ultrasound examination

CD control patients

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.

Other: Abdominal ultrasound examination

Interventions

Abdominal ultrasound examination OTHER

All subjects undergone abdominal ultrasonography at the Outpatient of Ultrasonography of the Department of Internal Medicine at the University Hospital of Palermo, Italy.

CD control patients; NCWS patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study included 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 January 2015 and November 2016, and sex- and age-matched subjects with CD, enrolled at the same centers, as controls patients. All subjects undergone abdominal ultrasonography at the Outpatient of Ultrasonography of the Department of Internal Medicine at the University Hospital of Palermo, Italy.

You may qualify if:

• 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.

You may not qualify if:

• 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
• other previously diagnosed gastrointestinal disorders
• nervous system disease and/or major psychiatric disorder
• physical impairment limiting physical activity.

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (2)

Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca

Sciacca, Agrigento, 92019, Italy

Location

Department of Internal Medicine, University Hospital of Palermo

Palermo, Palermo, 90129, Italy

Location

Related Publications (8)

• 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.

  PMID: 22825366 RESULT

• 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.

  PMID: 24533607 RESULT

• 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.

  PMID: 24275240 RESULT

• 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.

  PMID: 25625764 RESULT

• 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.

  PMID: 25430806 RESULT

• 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.

  PMID: 25694210 RESULT

• 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:S53-61. doi: 10.1055/s-0028-1110009. Epub 2010 Mar 16.

  PMID: 20235005 RESULT

• Soresi M, Mansueto P, Terranova A, D'Alcamo A, La Blasca F, Cavataio F, Iacobucci R, Carroccio A. Abdominal Ultrasound Does Not Reveal Significant Alterations in Patients With Nonceliac Wheat Sensitivity. J Clin Gastroenterol. 2019 Jan;53(1):e31-e36. doi: 10.1097/MCG.0000000000000969.

  PMID: 29206754 DERIVED

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Antonio Carroccio, PhD

  University of Palermo

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 30, 2016
• First Posted: January 11, 2017
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 11, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)