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Combining Nutritional Therapy and Anti-TNFα Treatment in Pediatric Patients With Crohn's Disease

NCT07314606 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-05-01

No results posted yet for this study

Summary

Children with Crohn's disease (CD), a type of Inflammatory Bowel Disease (IBD), often face serious health challenges, including poor growth, frequent hospital stays, and long-term medication use. Although biologic drugs like infliximab, an anti-TNFα (Tumor necrosis factor α) medication, have improved treatment, they don't work for everyone: many children still experience symptoms or disease flare-ups. Nutritional therapies, especially the Crohn's Disease Exclusion Diet (CDED), may help improve treatment outcomes. This study will assess whether starting CDED at the same time as infliximab leads to better responses to treatment. The goal of this study is to improve how well children respond to therapy, reduce drug exposure, and support better long-term health.

Conditions

  • Crohn Disease (CD)
  • IBD (Inflammatory Bowel Disease)
  • IBD - Inflammatory Bowel Disease

Interventions

OTHER

IFX + mCDED

modified Crohn's Disease Exclusion Diet (mCDED) ; Diet intervention

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Kevan Jacobson, MBBCh, FRCP, FRCPC, AGAF, CAGF · The University of British Columbia

  • Genelle Lunken, BSc, PhD, RD · The University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-22
Primary Completion
2029-10-01
Completion
2029-10-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07314606 on ClinicalTrials.gov