Interest of Urinary Measurement of Immunogenic Gluten Peptides (GIP) in the Follow-up of Pediatric Celiac Patients. (GIped)
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Aline JOULIE, PHD
- 電話番号：+33.4.92.03.05.20
- メール：joulie.a@chu-nice.fr
研究連絡先のバックアップ
- 名前：Valérie Dr Triolo, MD
- メール：valerie.triolo@hpu.lenval.com
研究場所
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Nice、フランス、06200
- Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval
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コンタクト：
- Valerie Dr Triolo, MD
- 電話番号：+33492030520
- メール：valerie.triolo@hpu.lenval.com
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Children aged 2 to 18 years.
- Confirmed diagnosis of celiac disease according to ESPGHAN criteria.
- Gluten-free diet followed for ≥ 6 months.
- Signed informed consent by one of the 2 parents or the legal guardian and oral or written assent from the child.
- Affiliation to a social security scheme
Exclusion Criteria:
- Predictable compliance problem in the study
- Non-French-speaking patient
- Seronegative celiac disease at diagnosis
- Chronic kidney disease
- Patient protected by law, that is, subject to protective measures (judicial safeguard, guardianship, trusteeship, procedures for opening guardianship and trusteeship measures)
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：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：GIP Group
The test used is the iVYCHECK GIP urine® test, a rapid immunochromatographic test used to detect immunogenic gluten peptides (GIP) in urine.
In the experimental group, urinary GIP levels are measured at M0, M6, and M12 with two urine samples collected at home at M6 and two urine samples collected at home at M12 in addition to the sample collected during the consultation.
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The test used is the iVYCHECK GIP urine® test, a rapid immunochromatographic test used to detect immunogenic gluten peptides (GIP) in urine.
In the experimental group, urinary GIP levels are measured at M0, M6, and M12 with two urine samples collected at home at M6 and two urine samples collected at home at M12 in addition to the sample collected during the consultation.
他の名前：
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アクティブコンパレータ：control group
The test used is the iVYCHECK GIP urine® test, a rapid immunochromatographic test used to detect immunogenic gluten peptides (GIP) in urine.
In the control group, standard follow-up at M0, M6.
At M12, two urine samples collected at home in addition to the sample collected during the consultation.
|
The test used is the iVYCHECK GIP urine® test, a rapid immunochromatographic test used to detect immunogenic gluten peptides (GIP) in urine.
In the control group, standard follow-up at M0, M6.
At M12, two urine samples collected at home in addition to the sample collected during the consultation.
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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 |
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Compare the 1-year effectiveness of a clinical follow-up strategy based on urinary GIP measurement versus standard care, in patients with celiac disease in the pediatric population.
時間枠：12 month
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The effectiveness of care guided by urinary GIP testing, combined with reinforced dietary assessment by a dietitian, will be evaluated at Month 12 using urinary GIP measurements. A positive GIP result is defined as evidence of recent gluten ingestion. The test provides an immediate binary outcome (positive or negative). At each assessment time point, patients will be classified as GIP-positive if at least one of the three urine tests performed is positive. At baseline (M0), where only a single test is conducted, GIP status will be determined based on that result alone. |
12 month
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Correlation between urinary GIP concentration and presence of gastrointestinal symptoms
時間枠：Month 0 (baseline), Month 6, and Month 12 in the experimental group; Month 12 in the control group.
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Assessment of the correlation between urinary glucose-dependent insulinotropic peptide (GIP) results, measured using the iVYCHECK GIP Urine Test (reported as positive or negative), and the presence of gastrointestinal symptoms.
Symptoms are defined as the presence of at least one of the following: abdominal pain, diarrhea, constipation, abdominal distension, or weight loss.
Symptom presence will be recorded as a binary outcome (yes/no).
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Month 0 (baseline), Month 6, and Month 12 in the experimental group; Month 12 in the control group.
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Correlation between urinary GIP test results and pediatrician assessment of gluten intake
時間枠：Month 0 (baseline), Month 6, and Month 12 in the experimental group; Month 12 in the control group.
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Assessment of the correlation between urinary glucose-dependent insulinotropic peptide (GIP) results, measured using the iVYCHECK GIP Urine Test (reported as positive or negative), and the assessment of gluten intake performed by a pediatrician. Gluten intake will be evaluated using a standardized clinical assessment based on parental interview and dietary review, and recorded as a binary outcome (gluten intake: yes/no). This assessment includes: voluntary consumption of gluten-containing foods, verification of product labels for gluten content, and evaluation of food choices during meals outside the home. |
Month 0 (baseline), Month 6, and Month 12 in the experimental group; Month 12 in the control group.
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Correlation between urinary GIP test results and anti-transglutaminase antibody serology
時間枠：Month 0 (baseline), Month 6, and Month 12 in the experimental group; Month 12 in the control group.
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Assessment of the correlation between urinary glucose-dependent insulinotropic peptide (GIP) results, measured using the iVYCHECK GIP Urine Test (reported as positive or negative), and anti-transglutaminase antibody levels measured in serum using an enzyme-linked immunosorbent assay (ELISA), expressed in international units per milliliter (IU/mL). Serology results will be analyzed both as a continuous variable (IU/mL) and as a categorical variable defined as negative (< 7 IU/mL) or positive (≥ 7 IU/mL), according to standard laboratory thresholds. Serological assessments will be performed according to routine clinical care at Month 0 (baseline), Month 6, and/or Month 12, as prescribed by the treating physician, in both the experimental and control groups. |
Month 0 (baseline), Month 6, and Month 12 in the experimental group; Month 12 in the control group.
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Assess the satisfaction of patients and parents regarding the integration of the GIP into the therapeutic follow-up strategy for adherence to the RSG
時間枠：Month 12
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Parental/child satisfaction will be assessed using a Likert scale responding to the following question: 'Does urinary GIP measurement during follow-up reassure you about proper adherence to the gluten-free diet?'
This question will be asked to patients over 13 years old or to parents if the child is under 13 years old, with 5 possible response levels, from strongly agree to strongly disagree.
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Month 12
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Valérie Dr Triolo, MD、Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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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