NCT02750735|Completed
Loading search results
Sponsor study identifier
observational
200
1 country
2
Study Start
January 2001
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2011
Actual (reported)Study Completion
March 2016
Actual (reported)In the last few years, a new clinical entity has emerged which includes patients who consider themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though they do not have celiac disease (CD) or wheat allergy. This clinical condition has been named non-celiac gluten sensitivity (NCGS), although in a recent article, the investigators suggested the term "non-celiac wheat sensitivity" (NCWS), because it is not known to date what component of wheat actually causes the symptoms. Nickel is the fourth most used metal and the most frequent cause of contact allergy in the industrialized world. As a natural element of the earth's crust small amounts are found in water, soil, and natural foods, especially plant ones. Nickel allergy not only affects the skin but also results in systemic manifestations. Systemic nickel allergy syndrome can have cutaneous (urticaria/angioedema, flares, itching), and/or gastrointestinal (meteorism, colic, diarrhoea) signs and symptoms. In this study, the investigators evaluated 1) the frequency of Nickel allergy and Systemic Nickel allergy syndrome in NCWS patients, and 2) the clinical, serological, and histological characteristics of NCWS patients with contact dermatitis Nickel positive in comparison to NCWS patients without contact dermatitis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2001
Date type not reportedThis date has not been verified as actual or estimated.
June 2011
Actual (reported)March 2016
Actual (reported)April 15, 2016
Actual (reported)April 25, 2016
Actual (reported)Nickel allergy and Systemic Nickel allergy syndrome in retrospective NCWS patients
Frequency of Nickel allergy and Systemic Nickel allergy syndrome in retrospective NCWS patients and controls
Up to 10 years
Nickel allergy and Systemic Nickel allergy syndrome in prospective NCWS patients
Frequency of Nickel allergy and Systemic Nickel allergy syndrome in prospective NCWS patients and controls
Up to 15 months
Characteristics of retrospective NCWS patients with contact dermatitis Nickel positive in comparison to retrospective NCWS patients without contact dermatitis and controls.
Up to 10 years
Characteristics of prospective NCWS patients with contact dermatitis Nickel positive in comparison to prospective NCWS patients without contact dermatitis and controls.
Up to 15 months
The clinical charts of NCWS patients attending the outpatient centers of the Department of Internal Medicine at the University Hospital of Palermo and the Department of Internal Medicine of the Hospital of Sciacca were retrospectively reviewed. Patients had all been diagnosed with NCWS between January 2001 and June 2011, by a DBPCC method, and included in a previously published study. These charts included specific sections for the presence of associated atopic diseases, including nickel allergy. In this way, the characteristics of the NCWS patients suffering from nickel allergy were compared with those of the NCWS patients who did not suffer from nickel allergy. Incomplete clinical charts were excluded.
The investigators also prospectively surveyed adult patients with functional gastroenterological symptoms according to the Rome III criteria, and a definitive diagnosis of NCWS. The patients were recruited between December 2014 and March 2016 at 3 centers: the two already mentioned and the Gastroenterology Unit of the ARNAS Civico Hospital of Palermo, Italy. Most of the patients had been referred due to gastrointestinal symptoms, the onset of which, they reported, could be related to wheat ingestion. Again, the characteristics of the NCWS patients suffering from nickel allergy were compared with those of the NCWS patients who did not suffer from nickel allergy.
To compare the frequency of nickel allergy in NCWS and non-NCWS patients, a control group composed of 70 irritable bowel syndrome (IBS) patients, was selected. These controls were randomly chosen by a computer-generated method from subjects diagnosed during the same period and age- (+/-2 years) and sex-matched (+/-5%) with the NCWS patients. The IBS controls had been receiving the same elimination diet as the NCWS patients and had not shown any clinical improvement; they belonged to the cohort of subjects the investigators had studied previously.
The study was divided into 2 different parts. In the first, the clinical charts of NCWS patients were retrospectively reviewed, comparing the characteristics of the ones suffering from nickel allergy with those who did not suffer from nickel allergy, using, as control group, 70 IBS patients. In the second, the investigators prospectively surveyed adult patients with functional gastroenterological symptoms (Rome III criteria) and a definitive diagnosis of NCWS, comparing the characteristics of the ones suffering from nickel allergy were compared with those who did not suffer from nickel allergy, using, as control group, 70 patients with functional gastroenterological symptoms.
Antonio Carroccio
Sciacca, Agrigento, Italy
Pasquale Mansueto
Palermo, Palermo, 90127, Italy
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.
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.
Antonio Carroccio, PhD
University of Palermo
200 participants (actual enrollment reported by the registry).
First Submitted
April 15, 2016
First Posted
April 25, 2016
Study Start
January 2001
Date type not reportedThis date has not been verified as actual or estimated.
As for the retrospective study, to compare the frequency of nickel allergy in NCWS and non-NCWS patients, a control group composed of 70 patients with functional gastroenterological symptoms, was selected, with the same criteria adopted for the retrospective study.
Contact the study team to confirm eligibility.
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.
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.
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.
Carroccio A, Brusca I, Mansueto P, D'alcamo A, Barrale M, Soresi M, Seidita A, La Chiusa SM, Iacono G, Sprini D. A comparison between two different in vitro basophil activation tests for gluten- and cow's milk protein sensitivity in irritable bowel syndrome (IBS)-like patients. Clin Chem Lab Med. 2013 Jun;51(6):1257-63. doi: 10.1515/cclm-2012-0609.
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.
D'Alcamo A, Mansueto P, Soresi M, Iacobucci R, Blasca F, Geraci G, Cavataio F, Fayer F, Arini A, Di Stefano L, Iacono G, Bosco L, Carroccio A. Contact Dermatitis Due to Nickel Allergy in Patients Suffering from Non-Celiac Wheat Sensitivity. Nutrients. 2017 Feb 2;9(2):103. doi: 10.3390/nu9020103.
Primary Completion
June 2011
Actual (reported)Study Completion
March 2016
Actual (reported)Last Updated
April 25, 2016
Record last verified: 2016-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: