Autoimmune Diseases and Serum Autoantibodies in Non-celiac Wheat Sensitivity Patients in Comparison to IBS Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Serum autoantibodies
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Serum autoantibodies
时间窗: 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
时间窗: 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.
Frequency of associated autoimmune diseases
时间窗: 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.
次要结局
未报告次要终点
研究者
Pasquale Mansueto
Clinical Professor
University of Palermo