Outcome measures for clinical trials in paediatric IBD: an evidence-based, expert-driven practical statement paper of the paediatric ECCO committee

Ruemmele, Frank M; Hyams, Jeffrey S.; Otley, Anthony; Griffiths, Anne M.; Kolho, Kaija Leena; Dias, Jorge Amil; Levine, Arie; Escher, Johanna C.; Taminiau, J. A. J. M.; Veres, Gábor; Colombel, Jean Fréd́eric; Vermeire, Séverine; Wilson, David C.; Turner, Dan

doi:10.1136/gutjnl-2014-307008

Cited by 74 publications

(45 citation statements)

References 100 publications

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“…Treatment for IBD in patients under the age of 18 years differs from treatment recommendations for adults, sometimes substantially (1,2,27,28). Two examples of this are intensiveness of treatment and drug authorization.…”

Section: Specific Features Of Ibd In Children and Adolescentsmentioning

confidence: 99%

Inflammatory Bowel Disease in Childhood and Adolescence

Däbritz¹,

Gerner²,

Enninger³

et al. 2017

Deutsches Ärzteblatt International

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Section: Specific Features Of Ibd In Children and Adolescentsmentioning

confidence: 99%

Inflammatory Bowel Disease in Childhood and Adolescence

Däbritz¹,

Gerner²,

Enninger³

et al. 2017

Deutsches Ärzteblatt International

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“…Validation-based scoring systems are available for adult IBD patients 7,8 but still under development for PIBD patients. 9 WCE is able to visualize the entire small bowel with minimal discomfort and can detect mucosal lesions with high sensitivity but low specificity. 10 Its use depends on local availability and expertise, and there is currently a lack of validated diagnostic criteria.…”

mentioning

confidence: 99%

Pediatric IBD-unclassified Is Less Common than Previously Reported; Results of an 8-Year Audit of the EUROKIDS Registry

Winter

Karolewska-Bochenek

Łazowska-Przeorek

et al. 2015

Inflammatory Bowel Diseases

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“…There are different outcome measures and definitions of remission in adult and pediatric UC [11]. In adult UC, there are indices to assess disease activity using clinical, endoscopic, quality of life, and histological parameters.…”

Section: Discussionmentioning

confidence: 99%

Clinical and Pathologic Remission of Pediatric Ulcerative Colitis with Serum-Derived Bovine Immunoglobulin Added to the Standard Treatment Regimen

Soriano

Ramos-Soriano

2017

Case Rep Gastroenterol

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Ulcerative colitis (UC) is a chronic inflammatory bowel disease that is particularly troublesome for pediatric patients, as current therapeutic options consist of biologic agents and steroids which alter the immune response and have the harmful side effect of leaving the patient more susceptible to opportunistic infections and eventual surgery. Another option for therapy exists in the form of serum-derived bovine immunoglobulin/protein isolate (SBI), the key ingredient in a medical food, EnteraGam®. The FDA has reviewed the safety of SBI and issued a no challenge letter to the generally recognized as safe (GRAS) findings for this medical food. The product also has no known food or drug interactions, no significant adverse effects, and no contraindications, save for beef allergy. SBI has been shown to induce clinical remission in adult populations and to decrease markers of inflammation in pediatric patients. Here, we present a detailed case of pediatric UC, including documentation of mucosal healing and decrease in pediatric UC activity index in a difficult to treat pediatric patient, after the addition of SBI to this patient’s treatment regimen.

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Outcome measures for clinical trials in paediatric IBD: an evidence-based, expert-driven practical statement paper of the paediatric ECCO committee

Abstract: It is crucial to perform paediatric trials early in the development of new drugs in order to reduce off-label use of IBD medication in children. The thoughtful choice of feasible and standardised outcome measures can help move us towards this goal.

Cited by 74 publications

References 100 publications

Inflammatory Bowel Disease in Childhood and Adolescence

Inflammatory Bowel Disease in Childhood and Adolescence

Pediatric IBD-unclassified Is Less Common than Previously Reported; Results of an 8-Year Audit of the EUROKIDS Registry

Clinical and Pathologic Remission of Pediatric Ulcerative Colitis with Serum-Derived Bovine Immunoglobulin Added to the Standard Treatment Regimen

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