← Issue №9/ week of Aug 30, 2026/IBD

Reporting and representation of participant race, ethnicity, and sex in pediatric IBD clinical trials.

From GI Signals issue №9: what this paper found, what it changes, and where it sits against the current standard of care, reviewed by Simon Mathews, MD.

IBD prospective cohort · n=8,273 · Aug 27, 2026 · Inflamm Bowel Dis · IF 4.5

Reporting and representation of participant race, ethnicity, and sex in pediatric IBD clinical trials.

Epidemiologypediatricepidemiologyhealth services
Clinical takeawayNo direct clinical action yet: this is an epidemiological study highlighting disparities in trial representation. Consider advocating for diversity action plans in trial design.
What it foundFemale participants were underrepresented in pediatric IBD trials (EIR 0.91, 95% CI 0.87-0.95), most markedly in CD trials (EIR 0.82, 95% CI 0.78-0.88). Black (EIR 0.55, 95% CI 0.42-0.71) and Hispanic (EIR 0.46, 95% CI 0.28-0.76) participants were underrepresented, while Asian/Pacific Islander participants were overrepresented (EIR 1.78, 95% CI 1.37-2.30).
ContextThis study confirms and quantifies known disparities in pediatric IBD trial representation, showing persistent underrepresentation of female, Black, and Hispanic children relative to disease burden.
Emergingsuggested applicable standard· American College of Gastroenterology, 'ACG Clinical Guideline: Management of Crohn’s Disease in Adults' (Lichtenstein GR, Loftus EV, Afzali A, et al., Am J Gastroenterol 2025;120(6):1225-1264). DOI 10.14309/ajg.0000000000003465, PMID 40701562.

Decision at stakeensuring equitable therapeutic benefit in pediatric IBD trials

No single passage of this standard matched the paper closely enough to quote, so none is shown. The standard is cited above.

Our full summary of this standard

DIAGNOSIS: Use fecal calprotectin (cutoff >50-100 μg/g) to differentiate inflammatory from noninflammatory disease OF THE COLON (strong, moderate). Ileocolonoscopy with biopsies for suspected CD; biopsy uninvolved mucosa to define histologic extent; small bowel imaging is part of the initial workup (key concepts, ungraded). CT enterography is comparable to MR enterography for small bowel detection; MRE should be used PREFERENTIALLY in patients younger than 35 years and where serial examinations are likely, because of radiation avoidance, MRE is not a blanket first choice. Intestinal ultrasound is a radiation-free ADJUNCT to diagnosis and to monitoring treatment response (key concept, ungraded, not a graded recommendation). Perform routine endoscopic CRC surveillance in Crohn's colitis (strong, moderate). MILD-TO-MODERATE / LOWER PROGRESSION RISK: Recommend AGAINST oral mesalamine for induction or maintenance (strong, moderate); sulfasalazine should be considered ONLY for symptomatic mild COLONIC CD (key concept). Controlled ileal-release budesonide 9 mg daily for induction of symptomatic remission in mildly-to-moderately active ileocecal CD (strong, moderate), but recommend AGAINST ileal-release budesonide for MAINTENANCE (strong, low). MODERATE-TO-SEVERE / HIGHER RISK: SUGGEST AGAINST requiring failure of conventional therapy before initiating advanced therapy (conditional, LOW, a permission to skip step-up, not a mandate to start advanced therapy upfront). Oral corticosteroids for short-term induction only (strong, low). Recommend AGAINST azathioprine 1.5-2.5 mg/kg/d and 6-mercaptopurine 0.75-1.5 mg/kg/d for INDUCTION (strong, moderate), but SUGGEST the same agents and doses for MAINTENANCE after corticosteroid-induced remission (conditional, low). Check TPMT before starting azathioprine/6-MP (strong, low); measure NUDT15 variants in patients of East Asian ancestry and TPMT variants in all patients prior to thiopurine initiation (strong, moderate). Methotrexate up to 25 mg weekly IM/SC for maintenance after corticosteroid induction (conditional, low). Anti-TNF agents (IV infliximab, SC adalimumab, SC certolizumab pegol) for induction and maintenance (strong, moderate). Recommend COMBINATION IV infliximab + thiopurine over either agent alone in patients naive to both (strong, moderate). Vedolizumab IV for induction and maintenance of symptomatic remission (strong, moderate). Ustekinumab (strong, moderate); risankizumab (strong, moderate), and risankizumab over ustekinumab in prior anti-TNF exposure (conditional, low); mirikizumab (strong, moderate); guselkumab IV-then-SC or all-SC (strong, moderate). Upadacitinib for induction and maintenance in patients PREVIOUSLY EXPOSED TO ANTI-TNF (strong, moderate), the ACG does not endorse it as a first-line biologic-naive option. SC infliximab and SC vedolizumab are maintenance options in responders to IV induction (strong, moderate). PERIANAL FISTULIZING: infliximab for induction (strong, moderate); adalimumab (conditional, low); antibiotics added to infliximab or adalimumab (conditional, very low); vedolizumab, ustekinumab, upadacitinib each (conditional, VERY LOW). Drain perianal abscesses and place setons before escalating advanced therapy (key concept). POST-OPERATIVE: endoscopic assessment at 6-12 months after surgically induced remission over no monitoring (conditional, moderate); in LOW post-op recurrence risk, continued observation rather than immediate medical therapy (conditional, very low); imidazole antibiotics (metronidazole) 1-2 g/d after small intestinal resection (conditional, low); in HIGH-risk CD, anti-TNF to prevent endoscopic recurrence (STRONG, moderate) and vedolizumab (CONDITIONAL, low), these two are not co-equal. SURGERY/ABSCESS: intra-abdominal abscess >2 cm should be treated with antibiotics plus a drainage procedure, and immunosuppression HELD until drainage is achieved (conditional, low). DISEASE MODIFIERS: counsel active smokers to quit; use NSAIDs with caution; assess stress, depression and anxiety as part of comprehensive care (key concepts).

American College of Gastroenterology, 'ACG Clinical Guideline: Management of Crohn’s Disease in Adults' (Lichtenstein GR, Loftus EV, Afzali A, et al., Am J Gastroenterol 2025;120(6):1225-1264). DOI 10.14309/ajg.0000000000003465, PMID 40701562. · reviewed 2026-07-21 ↗
Jiang Y … Wang Z · Inflammatory Bowel Diseases · IF 4.5 · PubMed ↗Permalink
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