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指定難病 — No.96

クローン病

検索語 Crohn Disease ・ 最終更新 2026-07-21 20:57 ・ 最新に更新

Data Sheet
指定 No.96
Src PubMed · CT.gov · jRCT

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( 01 )EVIDENCE / PUBMED · 5件

世界の論文

直近の研究を、やさしい日本語で

各論文の見出しにある「確からしさ」は、その研究がどれくらい信頼できるかの目安です。「理論段階」はまだ仮説に近く、下にいくほど多くの患者で検証されていて、「メタ解析」がもっとも信頼できます。

不明
MK-01 · PMID 42479304

Occult Free Perforation in a Patient with Poorly Controlled Crohn's Disease

Journal
Digestive diseases and sciences(2026 Jul)
Authors
7名
Type
Journal Article
PubMedで原文を見る
観察研究
MK-02 · PMID 42478630

Translation and Spanish validation of the Quality of Life Questionnaire for patients with perianal fistula in Crohn's disease (Sp CAF-QoL Scale)

Abstract / 原文

INTRODUCTION: Perianal fistulizing disease in Crohn's disease (CD) is associated with a marked impairment in quality of life. Currently, there are no Spanish-validated disease-specific instruments available to assess this impact. The aim of this study was to cross-culturally adapt and perform an initial psychometric validation of the Crohn's Anal Fistula Quality of Life (CAF-QoL) scale in a Spanish-speaking population with CD and perianal fistulas. MATERIALS AND METHODS: The original questionnaire was translated and back-translated following international guidelines for cross-cultural adaptation. The Spanish version (Sp CAF-QoL) was then administered in a prospective cohort of patients with CD and perianal fistulas, together with four validated questionnaires assessing quality of life and disease activity. Internal consistency (Cronbach's alpha and McDonald's omega), test-retest reproducibility (Lin's concordance correlation coefficient and Bland-Altman analysis), and convergent validity (Pearson correlations) were evaluated. RESULTS: Of 178 patients contacted, 94 completed the questionnaire and 60 completed the test-retest assessment four weeks later. The scale showed excellent internal consistency (α = 0.971; ω = 0.947). Lin's concordance correlation coefficient for the global score was 0.812, indicating moderate-to-good reproducibility. Moderate correlations were observed with the IBDQ-9, HADS, and PROMIS instruments, confirming adequate convergent validity. CONCLUSIONS: The Sp CAF-QoL appears to be a valid and reproducible Spanish version of the CAF-QoL for initial use in clinical and research settings. However, multicenter validation studies are still required, as well as assessment of responsiveness to clinical change and determination of the minimal clinically important difference.

Journal
Revista espanola de enfermedades digestivas(2026 Jul)
Authors
8名
Type
Journal Article
PubMedで原文を見る
基礎研究(細胞・動物など)
MK-03 · PMID 42478557

Exclusive enteral nutrition containing transforming growth factor-β improves intestinal barrier function in a colitis mouse model

Abstract / 原文

OBJECTIVES: Exclusive enteral nutrition (EEN) is the first-line treatment for pediatric Crohn's disease, but its mechanisms of action remain poorly understood. Our aim was to identify the mechanisms that could explain the anti-inflammatory effects of EEN, studying the nutritional composition and transforming growth factor-β (TGF-β) effects, in a mouse model of colitis. METHODS: Mice were treated with dextran sulfate sodium (DSS) to induce colitis. After DSS treatment, we compared two enteral nutrition formulas, and we evaluated the effect of TGF-β itself on clinical and microscopic inflammation, and intestinal permeability, by TGF-β-supplementation, -inhibition, or -deletion. Colonic crypts from DSS and EEN mice were cultured and their cellular properties were analyzed. RESULTS: Both EEN formulas improved weight recovery and disease activity index. In contrast, EEN mice treated with TGF-β formula presented faster weight recovery and decreased inflammatory parameters, with a normalized intestinal permeability, suggesting gut restitution and functionality. These functional improvements were not found in the absence of TGF-β in the formulas. Finally, organoids from colonic crypts treated with Modulen IBD® containing TGF-β showed enhanced survival and re-epithelialization capacity. CONCLUSIONS: Both EEN formulas have anti-inflammatory properties based on their nutritional composition. However, TGF-β plays a significant role in intestinal functional restitution.

Journal
Journal of pediatric gastroenterology and nutrition(2026 Jul)
Authors
7名
Type
Journal Article
PubMedで原文を見る
システマティックレビュー/メタ解析
MK-04 · PMID 42478214

Intestinal ultrasound for the detection of postoperative recurrence in Crohn's disease: a systematic review and meta-analysis

Abstract / 原文

BACKGROUND AND AIMS: Postoperative recurrence of Crohn's disease (CD) is common and may occur without symptoms. Ileocolonoscopy is the reference standard for detecting endoscopic recurrence, but its invasiveness limits repeated use. Intestinal ultrasound (IUS) is a non-invasive monitoring tool, although diagnostic criteria and ultrasound modalities vary across studies. We conducted a systematic review and diagnostic test accuracy meta-analysis to evaluate the performance of IUS for detecting postoperative recurrence. METHODS: PubMed/MEDLINE, EMBASE, Scopus, and the Cochrane Library were searched from inception to April 2025. Eligible studies evaluated IUS for postoperative recurrence in CD using ileocolonoscopy as the reference standard. Data were extracted to reconstruct independent 2 × 2 diagnostic tables. The primary synthesis used hierarchical bivariate binomial random-effects models to jointly estimate summary sensitivity and specificity. Heterogeneity was explored through subgroup analyses by ultrasound modality, Doppler use, contrast route, bowel wall thickness threshold, diagnostic definition, data collection period, and recurrence severity. RESULTS: Twelve studies were included in the systematic review and narrative synthesis; 11 provided reconstructable independent 2 × 2 data and were included in the bivariate meta-analysis. IUS showed high summary sensitivity of 87.6% (95% CI, 81.0%-92.1%; P < .001) and good summary specificity of 80.2% (95% CI, 60.6%-91.5%; P < .001). The false negative rate was 12.4% (95% CI, 7.9%-19.0%), the false positive rate was 19.8% (95% CI, 8.5%-39.4%), positive likelihood ratio was 4.436 (95% CI, 2.070-9.505), negative likelihood ratio was 0.154 (95% CI, 0.101-0.236), and diagnostic odds ratio was 28.8 (95% CI, 11.0-75.4). Diagnostic performance was generally consistent across studies, although differences in ultrasound protocols and bowel wall thickness thresholds, most commonly ≥3 or ≥5 mm, appeared to contribute to between-study variability. CONCLUSIONS: IUS shows high sensitivity and good specificity for postoperative recurrence surveillance in CD. Its interpretation should remain linked to ultrasound protocol, threshold, recurrence definition, and clinical context.

Journal
Journal of Crohn's & colitis(2026 Jul)
Authors
4名
Type
Journal Article, Systematic Review, Meta-Analysis
PubMedで原文を見る
システマティックレビュー/メタ解析
MK-05 · PMID 42477587

Meta-analysis: safety and efficacy of ustekinumab in pediatric inflammatory bowel disease patients with anti-TNF failure

Abstract / 原文

BACKGROUND & AIMS: Evidence for ustekinumab (UST) in pediatric inflammatory bowel disease (IBD) is limited, particularly in patients who do not respond to anti-tumor necrosis factor (anti-TNF) therapy. We conducted a meta-analysis to evaluate the efficacy and safety of UST in pediatric IBD after anti-TNF failure. METHODS: PubMed, Cochrane Library, Embase, and Web of Science were searched from inception through August 2025. We included studies reporting outcomes of UST in pediatric IBD patients with prior anti-TNF failure. Pooled estimates were calculated using fixed- or random-effects models according to heterogeneity (I2). RESULTS: Fifteen studies including 653 pediatric patients were analyzed. Pooled clinical remission rates were 57% (95% CI, 28%-86%) at 8-16 weeks and 68% (95% CI, 58%-79%) at week 52. Steroid-free clinical remission was 44% (95% CI, 38%-49%) at 8-16 weeks and 58% (95% CI, 45%-70%) at week 52. The pooled endoscopic remission rate was 42% (95% CI, 35%-49%) and a biochemical remission rate of 63% (95% CI, 40%-87%). Adverse events occurred in 20% of patients (95% CI, 9%-30%), and serious adverse events occurred in 1% (95% CI, 0%-2%). At week 52, clinical remission rates were 69% in Crohn's disease (CD) and 65% in ulcerative colitis (UC). CONCLUSION: In pediatric IBD patients with prior anti-TNF failure, UST was associated with favorable pooled remission rates and an acceptable safety profile, although substantial inter-study heterogeneity warrants cautious interpretation. These findings support UST as a feasible therapeutic option in this refractory pediatric setting; while highly generalizable to pediatric CD, the findings for the UC subgroup offer important preliminary evidence that warrants cautious interpretation due to limited precision.

Journal
BMC gastroenterology(2026 Jul)
Authors
11名
Type
Journal Article, Systematic Review
PubMedで原文を見る
( 02 )TRIALS / JAPAN · 8件

日本で参加できる治験

現在 募集中のもの

各治験の「対象の目安」は年齢などの参加条件の一部です。ここに合っていても他の条件(病状・治療歴など)があります。詳しい参加条件は各治験ページで確認し、参加の可否は必ず主治医とご相談ください。

募集中
TR-01 · NCT05442567

A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)

Phase
PHASE3
対象の目安
2歳以上
Country
日本・Croatia・Lithuania・Slovakia・アメリカ・イギリス・イスラエル・イタリア・オーストラリア・カナダ・ギリシャ・スペイン・チェコ・ハンガリー・ベルギー・ポーランド・中国・韓国
詳細・参加条件を見る
募集中
TR-02 · NCT06663332

A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants

Phase
PHASE3
対象の目安
3歳以上
Country
日本・Turkey (Türkiye)・アメリカ・アルゼンチン・イギリス・イタリア・オーストラリア・スペイン・ドイツ・フランス・ブラジル・ポルトガル・ポーランド・中国・韓国
詳細・参加条件を見る
募集中
TR-03 · NCT06405087

A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)

Phase
PHASE3
対象の目安
2歳〜17歳
Country
日本・Serbia・アイルランド・アメリカ・イタリア・オランダ・スイス・スペイン・デンマーク・ブルガリア・ベルギー・ポルトガル・ポーランド・ルーマニア・台湾・韓国
詳細・参加条件を見る
募集中
TR-04 · NCT04535882

Effectiveness of Serum Leucine-rich Alpha-2 Glycoprotein Levels on IBD

Phase
情報なし
対象の目安
詳細は治験ページで確認
Country
日本
詳細・参加条件を見る
募集中
TR-05 · NCT04844606

A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)

Phase
PHASE3
対象の目安
2歳〜19歳
Country
日本・アメリカ・イギリス・イスラエル・イタリア・オランダ・オーストリア・カナダ・スペイン・ドイツ・ノルウェー・ブラジル・ベルギー・ポルトガル・ポーランド・韓国
詳細・参加条件を見る
募集中
TR-06 · NCT06430801

A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)

Phase
PHASE3
対象の目安
16歳〜80歳
Country
日本・Croatia・Dominican Republic・Latvia・Lithuania・Saudi Arabia・Serbia・Slovakia・Turkey (Türkiye)・アイルランド・アメリカ・イギリス・イスラエル・イタリア・ウクライナ・オランダ・オーストラリア・オーストリア・カナダ・ギリシャ・コロンビア・シンガポール・ジョージア・スイス・スウェーデン・スペイン・チェコ・チリ・デンマーク・ドイツ・ニュージーランド・ハンガリー・フィンランド・フランス・ブラジル・ベルギー・ペルー・ポルトガル・ポーランド・マレーシア・メキシコ・ルーマニア・中国・南アフリカ・台湾・韓国・香港
詳細・参加条件を見る
募集中
TR-07 · NCT06958536

A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease

Phase
PHASE2
対象の目安
18歳〜75歳
Country
日本・アメリカ・イギリス・オーストラリア・スペイン・チェコ・ドイツ・フランス・ベルギー・ポーランド・中国・南アフリカ
詳細・参加条件を見る
募集中
TR-08 · NCT06332534

Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease

Phase
PHASE3
対象の目安
2歳〜17歳
Country
日本・Puerto Rico・アメリカ・イギリス・イタリア・オーストラリア・カナダ・ギリシャ・スペイン・ニュージーランド・フランス・ブラジル・ブルガリア・ベルギー・ポーランド・中国・台湾・韓国
詳細・参加条件を見る
( 03 )REGISTRY / jRCT

治験をもっと探す

日本の公式レジストリで全件を確認

上の一覧は ClinicalTrials.gov の一部です。日本国内の治験の多くは、日本の公式レジストリ jRCT にのみ登録されています。下記から最新の全件をご確認ください。

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( 04 )SUPPORT

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一人で抱え込まないでください

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