Non-celiac Gluten SensitivityNCT04077840
Autoimmune Diseases and Serum Autoantibodies in NCWS and IBS Patients
An observational study of Non-celiac Gluten Sensitivity and Non-celiac Wheat Sensitivity, run by University of Palermo at 2 sites in Italy.
Trial summary
In recent years, a new gluten- or wheat-related disease has emerged, a condition labelled "non-celiac gluten sensitivity" (NCGS) or "non-celiac wheat sensitivity" (NCWS). Given the lack of a diagnostic biomarker, NCGS/NCWS mostly remains a diagnosis of exclusion, especially respect to CD and WA, so a confirmatory test… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-celiac Gluten Sensitivity, Non-celiac Wheat Sensitivity
- Type of treatment
- Injection or infusion
- How many people
- 58 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jan 2016to 30 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: We prospectively surveyed 58 adult patients with a definitive diagnosis of NCWS, based on DBPC wheat challenge, most of them suffering from IBS-like-clinical presentation, according to Rome IV criteria. The patients were consecutively recruited between January 2016 and October 2017 at the outpatient clinics of the Department of Internal Medicine of the University Hospital of Palermo and the Department of Internal Medicine of the Hospital of Sciacca (both in southern Italy). Two control groups were selected. One included 76 consecutive healthy blood donors sex- (+ 5%) and age-matched (+ 2 years) with the NCWS patients, while the second included 55 patients with a diagnosis of IBS unrelated to NCWS or other types of food "intolerance/allergy", who were consecutively recruited during the study period and sex- (+ 5%) and age-matched (+ 2 years) with the NCWS patients.
Who may be able to join
- resolution of symptoms on a standard elimination diet, without wheat, cow's milk, yeast, and other food(s) causing self-reported symptoms
- symptom reappearance on a DBPC wheat challenge. As in previous studies, a DBPC cow's milk protein challenge and other open food challenges were also performed
- age above 18 years and <65 years
- follow-up duration longer than 12 months after the initial diagnosis
- at least two outpatient visits during the follow-up period.
Who cannot join
- positive serum assays for celiac disease (i.e. anti-tissue transglutaminase (anti-tTG) IgA and anti-deamidated gliadin peptides (anti-DGP) IgG antibodies)
- presence of intestinal villous atrophy, documented in all the patients carrying the DQ2 and/or the DQ8 HLA haplotypes
- positive IgE-mediated immune-allergy tests to wheat (skin prick tests and/or specific serum IgE detection).
- IBS IBS diagnosis had been made in accordance with the Rome IV criteria and none of these patients improved on an elimination diet without wheat, cow's milk, egg, tomato or chocolate.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Department of Internal Medicine, University Hospital of Palermo
Palermo, 90129
Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca
Sciacca, Agrigento, 92019
About this study
Official title: Autoimmune Diseases and Serum Autoantibodies in Non-celiac Wheat Sensitivity Patients in Comparison to IBS Patients
In recent years, a new gluten- or wheat-related disease has emerged, a condition labelled "non-celiac gluten sensitivity" (NCGS) or "non-celiac wheat sensitivity" (NCWS). Given the lack of a diagnostic biomarker, NCGS/NCWS mostly remains a diagnosis of exclusion, especially respect to CD and WA, so a confirmatory test is required. The Salerno experts suggested the double-blind, placebo-controlled (DBPC), cross-over, gluten/wheat challenge as the gold standard test to discriminate true NCGS/NCWS patients. There are conflicting data about the real mechanisms which induce symptoms in NCGS/NCWS patients after wheat ingestion. Some Authors suggested a prevalent role for Fermentable Oligosaccharides-Disaccharides-Monosaccharides and Polyols (FODMAPs), rather than gluten in determining the symptoms. Other studies underlined the activation of mechanisms of both innate and acquired immunity in NCWS patients, after wheat ingestion. In the present study, we included a group of consecutive NCWS patients, diagnosed with DBPC wheat challenge, to evaluate a) the frequency of autoimmune diseases, b) the frequency and pattern of serum ANA and other non-organ-specific and/or organ-specific autoantibodies, and c) the possible correlations between autoimmune diseases and serum autoantibodies presence and other NCWS-related disease characteristics, in comparison with age- and sex- matched healthy blood donors and IBS patients unrelated to NCWS.
Read the detailed description
In recent years, a new gluten- or wheat-related disease has emerged, a condition labelled "non-celiac gluten sensitivity" (NCGS) or "non-celiac wheat sensitivity" (NCWS). This is very often a self-reported condition, since patients refer to intestinal (mainly irritable bowel syndrome (IBS)-like) and/or extra-intestinal symptoms (i.e. fatigue, headache) caused by gluten or wheat ingestion, even though they do not have celiac disease (CD) or wheat allergy (WA). Given the lack of a diagnostic biomarker, NCGS/NCWS mostly remains a diagnosis of exclusion, especially respect to CD and WA, so a confirmatory test is required. The Salerno experts suggested the double-blind, placebo-controlled (DBPC), cross-over, gluten/wheat challenge as the gold standard test to discriminate true NCGS/NCWS patients.
However, there are conflicting data about the real mechanisms which induce symptoms in NCGS/NCWS patients after wheat ingestion. Some Authors suggested a prevalent role for Fermentable Oligosaccharides-Disaccharides-Monosaccharides and Polyols (FODMAPs), rather than gluten in determining the symptoms. Other studies underlined the activation of mechanisms of both innate and acquired immunity in NCWS patients, after wheat ingestion. In line with the evidence of an immunologic activation in NCWS, we showed in a previous study that about one quarter of NCWS patients suffered from associated autoimmune diseases (mainly Hashimoto's thyroiditis), compared with a smaller proportion of a control group including IBS patients (about 3%). Furthermore, we showed that serum samples of NCWS patients tested positive for anti-nuclear (ANA) in more than one third of the cases. However, that study included mainly patients evaluated in a retrospective manner and no other autoantibodies were evaluated apart from ANA.
In the present study, we included a group of consecutive NCWS patients, diagnosed with DBPC wheat challenge, to evaluate a) the frequency of autoimmune diseases, b) the frequency and pattern of serum ANA and other non-organ-specific and/or organ-specific autoantibodies, and c) the possible correlations between autoimmune diseases and serum autoantibodies presence and other NCWS-related disease characteristics, in comparison with age- and sex- matched healthy blood donors and IBS patients unrelated to NCWS.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NCGS/NCWS patients | Adult patients with a definitive diagnosis of NCWS, based on DBPC wheat challenge, most of them suffering from IBS-like-clinical presentation, according to Rome IV criteria. The patients were consecutively recruited between January 2016 and October 2017 at the outpatient clinics of the Department of Internal Medicine of the University Hospital of Palermo and the Department of Internal Medicine of the Hospital of Sciacca (both in southern Italy) | |
| Heathy blood donors | Consecutive healthy blood donors sex- (+ 5%) and age-matched (+ 2 years) with the NCWS patients. | |
| IBS patients | Consecutive patients with a diagnosis of IBS unrelated to NCWS or other types of food "intolerance/allergy", who were consecutively recruited during the study period and sex- (+ 5%) and age-matched (+ 2 years) with the NCWS patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of associated autoimmune diseases
The presence of autoimmune disorders both in NCWS and IBS control patients was evaluated by a structured questionnaire and a review of patients' clinical records. The presence of one of the following was looked for in all subjects: connective tissue diseases, autoimmune endocrinological diseases, autoimmune hepatitis, primary biliary cirrhosis, epilepsy with cerebral calcification, unexplained cerebellar ataxia, alopecia, psoriasis, atrophic autoimmune gastritis, and immune anemia, neutropenia, or thrombocytopenia.
Measured: 22 months
Serum autoantibodies
The frequency, titers and patterns of serum ANA, antibodies against double stranded DNA (anti-dsDNA), extractable nuclear antigen (ENA), islet cells of the pancreas (ICA), parietal cell antibodies (APCA), and, finally, tireoglobulin (anti-TG) and thyroid peroxidase (anti-TPO) were evaluated by ELISA and Immunofluorescence.
Measured: 22 months
Clinical characteristics of NCWS and IBS patients
Frequency of autoimmune diseases and autoantibodies were correlated with the following clinical and laboratory parameters: age at diagnosis, gender, coexistent pathologies, atopic diseases and nickel allergy, anemia, coexistent other food allergies, presence of IBS-like symptoms, functional dyspepsia, and extraintestinal symptoms, BMI, duodenal histology lesions, and DQ2/DQ8 HLA haplotypes.
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start1 Jan 2016
- Primary completion1 Jan 2017
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Non-celiac Gluten SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pasquale Mansueto, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077840
- Sponsor's protocol ID
- ACPM22
- Status last verified
- Apr 2020
- First submitted
- 31 Aug 2019
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carroccio A, D'Alcamo A, Cavataio F, Soresi M, Seidita A, Sciume C, Geraci G, Iacono G, Mansueto P. High Proportions of People With Nonceliac Wheat Sensitivity Have Autoimmune Disease or Antinuclear Antibodies. Gastroenterology. 2015 Sep;149(3):596-603.e1. doi: 10.1053/j.gastro.2015.05.040. Epub 2015 May 27.
PubMed 26026392Carroccio A, Mansueto P, D'Alcamo A, Iacono G. Non-celiac wheat sensitivity as an allergic condition: personal experience and narrative review. Am J Gastroenterol. 2013 Dec;108(12):1845-52; quiz 1853. doi: 10.1038/ajg.2013.353. Epub 2013 Nov 5.
PubMed 24169272Carroccio 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.
PubMed 22825366Carroccio 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.
PubMed 24275240Catassi C, Elli L, Bonaz B, Bouma G, Carroccio A, Castillejo G, Cellier C, Cristofori F, de Magistris L, Dolinsek J, Dieterich W, Francavilla R, Hadjivassiliou M, Holtmeier W, Korner U, Leffler DA, Lundin KE, Mazzarella G, Mulder CJ, Pellegrini N, Rostami K, Sanders D, Skodje GI, Schuppan D, Ullrich R, Volta U, Williams M, Zevallos VF, Zopf Y, Fasano A. Diagnosis of Non-Celiac Gluten Sensitivity (NCGS): The Salerno Experts' Criteria. Nutrients. 2015 Jun 18;7(6):4966-77. doi: 10.3390/nu7064966.
PubMed 26096570Di Liberto D, Mansueto P, D'Alcamo A, Lo Pizzo M, Lo Presti E, Geraci G, Fayer F, Guggino G, Iacono G, Dieli F, Carroccio A. Predominance of Type 1 Innate Lymphoid Cells in the Rectal Mucosa of Patients With Non-Celiac Wheat Sensitivity: Reversal After a Wheat-Free Diet. Clin Transl Gastroenterol. 2016 Jul 7;7(7):e178. doi: 10.1038/ctg.2016.35.
PubMed 27388423Drossman DA. Functional Gastrointestinal Disorders: History, Pathophysiology, Clinical Features and Rome IV. Gastroenterology. 2016 Feb 19:S0016-5085(16)00223-7. doi: 10.1053/j.gastro.2016.02.032. Online ahead of print.
PubMed 27144617Losurdo G, Principi M, Iannone A, Giangaspero A, Piscitelli D, Ierardi E, Di Leo A, Barone M. Predictivity of Autoimmune Stigmata for Gluten Sensitivity in Subjects with Microscopic Enteritis: A Retrospective Study. Nutrients. 2018 Dec 18;10(12):2001. doi: 10.3390/nu10122001.
PubMed 30567296Mansueto 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.
PubMed 24533607Sapone A, Bai JC, Ciacci C, Dolinsek J, Green PH, Hadjivassiliou M, Kaukinen K, Rostami K, Sanders DS, Schumann M, Ullrich R, Villalta D, Volta U, Catassi C, Fasano A. Spectrum of gluten-related disorders: consensus on new nomenclature and classification. BMC Med. 2012 Feb 7;10:13. doi: 10.1186/1741-7015-10-13.
PubMed 22313950
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autoimmune Diseases and Serum Autoantibodies in Non-celiac Wheat Sensitivity Patients in Comparison to IBS Patients
- ClinicalTrials.gov ID
- NCT04077840
- Acronym / sponsor ID
- ACPM22
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 4 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In recent years, a new gluten- or wheat-related disease has emerged, a condition labelled "non-celiac gluten sensitivity" (NCGS) or "non-celiac wheat sensitivity" (NCWS). Given the lack of a diagnostic biomarker, NCGS/NCWS mostly remains a diagnosis of exclusion, especially respect to CD and WA, so a confirmatory test is required. The Salerno experts suggested the double-blind, placebo-controlled (DBPC), cross-over, gluten/wheat challenge as the gold standard test to discriminate true NCGS/NCWS patients. There are conflicting data about the real mechanisms which induce symptoms in NCGS/NCWS patients after wheat ingestion. Some Authors suggested a prevalent role for Fermentable Oligosaccharides-Disaccharides-Monosaccharides and Polyols (FODMAPs), rather than gluten in determining the symptoms. Other studies underlined the activation of mechanisms of both innate and acquired immunity in NCWS patients, after wheat ingestion. In the present study, we included a group of consecutive NCWS patients, diagnosed with DBPC wheat challenge, to evaluate a) the frequency of autoimmune diseases, b) the frequency and pattern of serum ANA and other non-organ-specific and/or organ-specific autoantibodies, and c) the possible correlations between autoimmune diseases and serum autoantibodies presence and other NCWS-related disease characteristics, in comparison with age- and sex- matched healthy blood donors and IBS patients unrelated to NCWS.
Detailed description
In recent years, a new gluten- or wheat-related disease has emerged, a condition labelled "non-celiac gluten sensitivity" (NCGS) or "non-celiac wheat sensitivity" (NCWS). This is very often a self-reported condition, since patients refer to intestinal (mainly irritable bowel syndrome (IBS)-like) and/or extra-intestinal symptoms (i.e. fatigue, headache) caused by gluten or wheat ingestion, even though they do not have celiac disease (CD) or wheat allergy (WA). Given the lack of a diagnostic biomarker, NCGS/NCWS mostly remains a diagnosis of exclusion, especially respect to CD and WA, so a confirmatory test is required. The Salerno experts suggested the double-blind, placebo-controlled (DBPC), cross-over, gluten/wheat challenge as the gold standard test to discriminate true NCGS/NCWS patients.
However, there are conflicting data about the real mechanisms which induce symptoms in NCGS/NCWS patients after wheat ingestion. Some Authors suggested a prevalent role for Fermentable Oligosaccharides-Disaccharides-Monosaccharides and Polyols (FODMAPs), rather than gluten in determining the symptoms. Other studies underlined the activation of mechanisms of both innate and acquired immunity in NCWS patients, after wheat ingestion. In line with the evidence of an immunologic activation in NCWS, we showed in a previous study that about one quarter of NCWS patients suffered from associated autoimmune diseases (mainly Hashimoto's thyroiditis), compared with a smaller proportion of a control group including IBS patients (about 3%). Furthermore, we showed that serum samples of NCWS patients tested positive for anti-nuclear (ANA) in more than one third of the cases. However, that study included mainly patients evaluated in a retrospective manner and no other autoantibodies were evaluated apart from ANA.
In the present study, we included a group of consecutive NCWS patients, diagnosed with DBPC wheat challenge, to evaluate a) the frequency of autoimmune diseases, b) the frequency and pattern of serum ANA and other non-organ-specific and/or organ-specific autoantibodies, and c) the possible correlations between autoimmune diseases and serum autoantibodies presence and other NCWS-related disease characteristics, in comparison with age- and sex- matched healthy blood donors and IBS patients unrelated to NCWS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NCGS/NCWS patients | – | –Adult patients with a definitive diagnosis of NCWS, based on DBPC wheat challenge, most of them suffering from IBS-like-clinical presentation, according to Rome IV criteria. The patients were consecutively recruited between January 2016 and October 2017 at the outpatient clinics of the Department of Internal Medicine of the University Hospital of Palermo and the Department of Internal Medicine of the Hospital of Sciacca (both in southern Italy) |
| Heathy blood donors | – | –Consecutive healthy blood donors sex- (+ 5%) and age-matched (+ 2 years) with the NCWS patients. |
| IBS patients | – | –Consecutive patients with a diagnosis of IBS unrelated to NCWS or other types of food "intolerance/allergy", who were consecutively recruited during the study period and sex- (+ 5%) and age-matched (+ 2 years) with the NCWS patients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- We prospectively surveyed 58 adult patients with a definitive diagnosis of NCWS, based on DBPC wheat challenge, most of them suffering from IBS-like-clinical presentation, according to Rome IV criteria. The patients were consecutively recruited between January 2016 and October 2017 at the outpatient clinics of the Department of Internal Medicine of the University Hospital of Palermo and the Department of Internal Medicine of the Hospital of Sciacca (both in southern Italy). Two control groups were selected. One included 76 consecutive healthy blood donors sex- (+ 5%) and age-matched (+ 2 years) with the NCWS patients, while the second included 55 patients with a diagnosis of IBS unrelated to NCWS or other types of food "intolerance/allergy", who were consecutively recruited during the study period and sex- (+ 5%) and age-matched (+ 2 years) with the NCWS patients.
Key inclusion criteria (5 listed)
- resolution of symptoms on a standard elimination diet, without wheat, cow's milk, yeast, and other food(s) causing self-reported symptoms
- symptom reappearance on a DBPC wheat challenge. As in previous studies, a DBPC cow's milk protein challenge and other open food challenges were also performed
- age above 18 years and <65 years
- follow-up duration longer than 12 months after the initial diagnosis
- at least two outpatient visits during the follow-up period.
Key exclusion criteria (4 listed)
- positive serum assays for celiac disease (i.e. anti-tissue transglutaminase (anti-tTG) IgA and anti-deamidated gliadin peptides (anti-DGP) IgG antibodies)
- presence of intestinal villous atrophy, documented in all the patients carrying the DQ2 and/or the DQ8 HLA haplotypes
- positive IgE-mediated immune-allergy tests to wheat (skin prick tests and/or specific serum IgE detection).
- IBS IBS diagnosis had been made in accordance with the Rome IV criteria and none of these patients improved on an elimination diet without wheat, cow's milk, egg, tomato or chocolate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of associated autoimmune diseases
Time frame: 22 months
The presence of autoimmune disorders both in NCWS and IBS control patients was evaluated by a structured questionnaire and a review of patients' clinical records. The presence of one of the following was looked for in all subjects: connective tissue diseases, autoimmune endocrinological diseases, autoimmune hepatitis, primary biliary cirrhosis, epilepsy with cerebral calcification, unexplained cerebellar ataxia, alopecia, psoriasis, atrophic autoimmune gastritis, and immune anemia, neutropenia, or thrombocytopenia.
Serum autoantibodies
Time frame: 22 months
The frequency, titers and patterns of serum ANA, antibodies against double stranded DNA (anti-dsDNA), extractable nuclear antigen (ENA), islet cells of the pancreas (ICA), parietal cell antibodies (APCA), and, finally, tireoglobulin (anti-TG) and thyroid peroxidase (anti-TPO) were evaluated by ELISA and Immunofluorescence.
Clinical characteristics of NCWS and IBS patients
Time frame: 22 months
Frequency of autoimmune diseases and autoantibodies were correlated with the following clinical and laboratory parameters: age at diagnosis, gender, coexistent pathologies, atopic diseases and nickel allergy, anemia, coexistent other food allergies, presence of IBS-like symptoms, functional dyspepsia, and extraintestinal symptoms, BMI, duodenal histology lesions, and DQ2/DQ8 HLA haplotypes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Results publication: PubMed 26026392Carroccio A, D'Alcamo A, Cavataio F, Soresi M, Seidita A, Sciume C, Geraci G, Iacono G, Mansueto P. High Proportions of People With Nonceliac Wheat Sensitivity Have Autoimmune Disease or Antinuclear Antibodies. Gastroenterology. 2015 Sep;149(3):596-603.e1. doi: 10.1053/j.gastro.2015.05.040. Epub 2015 May 27.
- Results publication: PubMed 24169272Carroccio A, Mansueto P, D'Alcamo A, Iacono G. Non-celiac wheat sensitivity as an allergic condition: personal experience and narrative review. Am J Gastroenterol. 2013 Dec;108(12):1845-52; quiz 1853. doi: 10.1038/ajg.2013.353. Epub 2013 Nov 5.
- Results publication: PubMed 22825366Carroccio 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.
- Results publication: PubMed 24275240Carroccio 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.
- Results publication: PubMed 26096570Catassi C, Elli L, Bonaz B, Bouma G, Carroccio A, Castillejo G, Cellier C, Cristofori F, de Magistris L, Dolinsek J, Dieterich W, Francavilla R, Hadjivassiliou M, Holtmeier W, Korner U, Leffler DA, Lundin KE, Mazzarella G, Mulder CJ, Pellegrini N, Rostami K, Sanders D, Skodje GI, Schuppan D, Ullrich R, Volta U, Williams M, Zevallos VF, Zopf Y, Fasano A. Diagnosis of Non-Celiac Gluten Sensitivity (NCGS): The Salerno Experts' Criteria. Nutrients. 2015 Jun 18;7(6):4966-77. doi: 10.3390/nu7064966.
- Results publication: PubMed 27388423Di Liberto D, Mansueto P, D'Alcamo A, Lo Pizzo M, Lo Presti E, Geraci G, Fayer F, Guggino G, Iacono G, Dieli F, Carroccio A. Predominance of Type 1 Innate Lymphoid Cells in the Rectal Mucosa of Patients With Non-Celiac Wheat Sensitivity: Reversal After a Wheat-Free Diet. Clin Transl Gastroenterol. 2016 Jul 7;7(7):e178. doi: 10.1038/ctg.2016.35.
- Results publication: PubMed 27144617Drossman DA. Functional Gastrointestinal Disorders: History, Pathophysiology, Clinical Features and Rome IV. Gastroenterology. 2016 Feb 19:S0016-5085(16)00223-7. doi: 10.1053/j.gastro.2016.02.032. Online ahead of print.
- Results publication: PubMed 30567296Losurdo G, Principi M, Iannone A, Giangaspero A, Piscitelli D, Ierardi E, Di Leo A, Barone M. Predictivity of Autoimmune Stigmata for Gluten Sensitivity in Subjects with Microscopic Enteritis: A Retrospective Study. Nutrients. 2018 Dec 18;10(12):2001. doi: 10.3390/nu10122001.
- Results publication: PubMed 24533607Mansueto 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.
- Results publication: PubMed 22313950Sapone A, Bai JC, Ciacci C, Dolinsek J, Green PH, Hadjivassiliou M, Kaukinen K, Rostami K, Sanders DS, Schumann M, Ullrich R, Villalta D, Volta U, Catassi C, Fasano A. Spectrum of gluten-related disorders: consensus on new nomenclature and classification. BMC Med. 2012 Feb 7;10:13. doi: 10.1186/1741-7015-10-13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-celiac Gluten Sensitivity and Non-celiac Wheat Sensitivity, run by University of Palermo at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of associated autoimmune diseases (time frame: 22 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04077840, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.