Prevalence of Gluten Sensitivity in Irritable Bowel Syndrome: The First Study in Paediatrics. (GS-IBS)
Prevalence of Gluten Sensitivity in Irritable Bowel Syndrome: The First Study in Paediatrics. (GS-IBS)
Recently a new clinical entity, gluten sensitivity (GS), a form of gluten intolerance in which neither allergic nor autoimmune mechanisms can be identified, has been added to the spectrum of gluten-related disorders. This condition is characterized by gastrointestinal and extra-intestinal symptoms including abdominal pain (68%); eczema or rash (40%); headache (35%); diarrhoea (33%) and fatigue (33%). The small intestine of GS patient is usually normal. The prevalence of GS is not yet established although it is estimated that up to 6% of the general population might be affected. GS has been described only in adults and no data are available for the paediatric population.The main problem with this new condition is that, at present, there are no specific biomarkers to confirm GS diagnosis. In the absence of a serological or histological marker, the diagnosis remains clinical. In order to avoid placebo effect of the dietary treatment, presently GS diagnosis needs to performed with double-blind randomized placebo-controlled challenge provided that both wheat allergy and CD have previously been excluded.
The primary aim of the study is to evaluate the prevalence of GS in IBS paediatric patients.
The secondary aims are: 1) to describe clinical, serologic, genetic and histological profile of GS patient and 2) to study the role of gluten or other possible wheat components in the onset of GS.
Study design Randomized double blind placebo controlled cross over re-challenge trial. Patient consecutively diagnosed as having IBS (Rome III criteria) in whom the diagnosis of coeliac disease and wheat allergy has been excluded, will be considered eligible for the study.
Diagnosis of coeliac disease and wheat allergy will be excluded by the negativity of TTG-IgA and/or EMA and of Skin Prick Test, RAST immuno-CAP and Atopy patch test respectively.
Patients will entered a three-phase study with a running in phase (phase I: weeks 1-2), diagnostic elimination diet phase (phase II: week 3-4) and re-challenge phase (phase III: week 5-12)
調査の概要
詳細な説明
Randomized double blind placebo controlled cross over re-challenge trial. Patient consecutively diagnosed as having IBS (Rome III criteria) in whom the diagnosis of coeliac disease and wheat allergy has been excluded, will be considered eligible for the study.
Diagnosis of coeliac disease and wheat allergy will be excluded by the negativity of TTG-IgA and/or EMA and of Skin Prick Test, RAST immuno-CAP and Atopy patch test respectively.
Patients will entered a three-phase study with a running in phase (phase I: weeks 1-2), diagnostic elimination diet phase (phase II: week 3-4) and re-challenge phase (phase III: week 5-12).
The following procedure will be performed at different times (Table 1):
- Entry (Time 0): Blood test, HLA on blood spot, collection of urine and stools;
Running-in (phase I: week 1-2): Visual Analogue Scale (VAS) and (IBS-SS); STAIC test; Bristol stool chart (mBSFC), extra-intestinal symptoms questionnaire.
At the end of week 2 patients still complaining IBS symptoms (IBS-SS>75) will proceed in the trial and undergo endoscopy plus biopsies on voluntary basis.
Diagnostic gluten elimination diet phase (phase II: week 3-4): Visual Analogue Scale (VAS) and (IBS-SS); STAIC test; Bristol stool chart (mBSF-C), extra-intestinal symptoms questionnaire. Collection of urine and stools (end of week 4).
At the end of week 4 only patients with a significant reduction of IBS symptoms or VAS (greater than 30%) will proceed in the re-challenge phase.
The challenge phase will be subdivided in Two phases: one double blind phase (product A and B) plus a single blind phase (product C).
- Product A (week 5-6): Visual Analogue Scale (VAS) and (IBS-SS), STAIC test; Bristol stool chart (mBSF-C), extra-intestinal symptoms questionnaire, collection of urine and stools (end of week 6);
- Product B (week 8-9): Visual Analogue Scale (VAS) and (IBS-SS), STAIC test; Bristol stool chart (mBSF-C), extra-intestinal symptoms questionnaire, collection of urine and stools (end of week 9)
- Product C (week 11-12): Visual Analogue Scale (VAS) and (IBS-SS), STAIC test; Bristol stool chart (mBSF-C), extra-intestinal symptoms questionnaire, collection of urine and stools (end of week 12)
Challenge procedure
Double Blind phase (Product A and B):
Children will be asked to keep following the strict gluten free diet and to take a sachet daily for a period of two weeks each interspersed by a washout phase of one week. Sachet will contain either pure gluten (10 grams daily) or gluten free flour (10 grams daily - SHAR). Sachets containing placebo will have the same shape, dimension, indication and appearance as those containing the gluten and will be provided by a bagging factory, which will ensure that the study will be blinded for investigators and patients. Sachets will be named A or B.
Single Blind Challenge (Product C):
To assess whether other components of wheat other gluten are involved in the onset of GS, children will be asked to take for a period of two weeks, while on gluten free diet, a muffin made of wheat flour in a single blind fashion.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Ruggiero Francavilla, MD
- 電話番号:00395592063
- メール:rfrancavilla@me.com
研究場所
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Ba
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Bari、Ba、イタリア、70126
- 募集
- Pediatric Department "B Trambusti" Ospedale Giovanni XXIII Via Amendola 270
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主任研究者:
- Ruggiero Francavilla, MD
-
副調査官:
- Fernanda Cristofori, MD
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コンタクト:
- Fernanda Cristofori
- メール:fernandacristofori@gmail.com
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age 4-18 years;
- IBS diagnosis according to Roma III criteria;
- Written informed consent.
Exclusion Criteria:
- Coeliac disease;
- Wheat allergy;
- Others food allergy;
- Type 1 Diabetes;
- Others Chronic and or Malignant diseases;
- H. Pylori infection.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:診断
- 割り当て:ランダム化
- 介入モデル:クロスオーバー割り当て
- マスキング:トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
他の:rechallenge
Double blind placebo controlled cross over
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
The standardized questionnaire (IBS-SS)
時間枠:12 weeks
|
The severity of IBS symptoms
|
12 weeks
|
Visual Analog Scale (VAS)
時間枠:12 weeks
|
12 weeks
|
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Quality of life Questionnaire
時間枠:12 weeks
|
12 weeks
|
|
The Faces Pain Scale (FPS)
時間枠:12 weeks
|
12 weeks
|
協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- 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.
- Biesiekierski JR, Newnham ED, Irving PM, Barrett JS, Haines M, Doecke JD, Shepherd SJ, Muir JG, Gibson PR. Gluten causes gastrointestinal symptoms in subjects without celiac disease: a double-blind randomized placebo-controlled trial. Am J Gastroenterol. 2011 Mar;106(3):508-14; quiz 515. doi: 10.1038/ajg.2010.487. Epub 2011 Jan 11.
- Biesiekierski JR, Peters SL, Newnham ED, Rosella O, Muir JG, Gibson PR. No effects of gluten in patients with self-reported non-celiac gluten sensitivity after dietary reduction of fermentable, poorly absorbed, short-chain carbohydrates. Gastroenterology. 2013 Aug;145(2):320-8.e1-3. doi: 10.1053/j.gastro.2013.04.051. Epub 2013 May 4.
- Volta U, Bardella MT, Calabro A, Troncone R, Corazza GR; Study Group for Non-Celiac Gluten Sensitivity. An Italian prospective multicenter survey on patients suspected of having non-celiac gluten sensitivity. BMC Med. 2014 May 23;12:85. doi: 10.1186/1741-7015-12-85.
- Catassi C, Bai JC, Bonaz B, Bouma G, Calabro A, Carroccio A, Castillejo G, Ciacci C, Cristofori F, Dolinsek J, Francavilla R, Elli L, Green P, Holtmeier W, Koehler P, Koletzko S, Meinhold C, Sanders D, Schumann M, Schuppan D, Ullrich R, Vecsei A, Volta U, Zevallos V, Sapone A, Fasano A. Non-Celiac Gluten sensitivity: the new frontier of gluten related disorders. Nutrients. 2013 Sep 26;5(10):3839-53. doi: 10.3390/nu5103839.
- Francavilla R, Cristofori F, Verzillo L, Gentile A, Castellaneta S, Polloni C, Giorgio V, Verduci E, D'Angelo E, Dellatte S, Indrio F. Randomized Double-Blind Placebo-Controlled Crossover Trial for the Diagnosis of Non-Celiac Gluten Sensitivity in Children. Am J Gastroenterol. 2018 Mar;113(3):421-430. doi: 10.1038/ajg.2017.483. Epub 2018 Jan 30.
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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