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

NCT07314606 | Recruiting

• 2 other identifiers: H25-02014GR034356
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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

IBD - Inflammatory Bowel Disease; Crohn Disease (CD)

Keywords

CDED; Exclusion Diet; Infliximab; Nutritional therapy; Pediatric; Diet Intervention

Outcome Measures

Primary Outcomes (1)

• Clinical and biochemical response at the first infliximab (IFX) maintenance dose (week 12) in participants receiving mCDED alongside IFX compared with participants receiving IFX alone.

  Clinical response: defined as mild or inactive clinical disease (at least a 17.5-points decrease in weighted paediatric Crohn's disease activity index (wPCDAI) from baseline, with a score \< 40), physician global assessment (PGA) of inactive or mild disease activity, off steroids, continuation on the same anti-TNFα dose, and remaining surgery-free. Biochemical response: Defined as at least a 50% decrease in fecal calprotectin (FCP) levels compared to baseline. wPCDAI ranges from 0 to 125, with higher scores indicating greater disease activity. PGA ranges from 0 to 10, with higher scores indicating greater disease activity.

  12 weeks

Secondary Outcomes (10)

• Steroid-free clinical and biochemical remission at week 12 in participants receiving mCDED alongside IFX compared with participants receiving IFX alone.

  12 weeks

• Steroid-free clinical and biochemical response at weeks 24 and 52 in participants receiving mCDED alongside IFX compared with participants receiving IFX alone.

  24 and 52 weeks

• Proportion of participants achieving steroid-free clinical and biochemical remission at weeks 24 and 52 in participants receiving mCDED alongside IFX compared with participants receiving IFX alone.

  weeks 24 and 52

• 1-year composite score of clinical remission and biochemical remission in addition to meeting criteria for steroid-free clinical remission adjusted for week 12 IFX trough level.

  Week 52

• Endoscopic response and endoscopic remission at week 52 in participants receiving mCDED alongside infliximab (IFX) compared with participants receiving IFX alone.

  Week 52

Study Arms (2)

IFX + mCDED

EXPERIMENTAL

Participants will follow the modified Crohn's disease exclusion diet (mCDED) for 6 months, when initiating their infliximab therapy as part of their routine care

Other: IFX + mCDED

IFX

NO INTERVENTION

Participants will initiate their infliximab therapy as part of their routine care

Interventions

IFX + mCDED OTHER

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

IFX + mCDED

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Moderate-severe active luminal inflammatory (B1) pCD \[wPCDAI \> or = 40\] ileal +/- colonic (L1, L2, L3), and in whom treating physician plans to start IFX
• OR Strong suspicion of moderate-severe active luminal inflammatory (B1) pCD ileal +/- colonic (L1, L2, L3), and in whom treating physician plans to start IFX
• Within 12-months of diagnosis (when starting IFX treatment)
• Naïve to a biologic therapy
• For patients with established disease who flare up: no response to dietary intervention or steroids within 4 weeks of commencement of these therapies.
• For newly diagnosed patients: no response to dietary intervention or steroids within 2 weeks of commencement of these therapies.
• Evidence of active inflammation: FCP level \> 250 µg/g and/ or CRP \> 5 mg/L or ESR \> 20 mm/hr
• BMI between the 5th and 95th percentiles, adjusted for age and sex
• On steroids or EEN for less than 2 (or 4, for established disease) weeks
• Able and willing to follow dietary recommendations
• On stable dose of AZA or Methotrexate (MTX) at randomization
• Willing to enroll in the CIDsCaNN Network study

You may not qualify if:

• CDED, EEN, or steroids commenced more than 2 weeks prior to randomization
• Antibiotic use in the last 2 months (except short course \< 1 week between 1-2 months) or laxative use within the past month (except for bowel prep for endoscopy pre commencement of anti-TNFα)
• Pre-, pro-, synbiotic supplements in the last month (food containing these products, e.g. yogurt, allowed)
• Strict vegetarians and vegans
• High risk of malnutrition as assessed by the Paediatric Yorkhill Malnutrition Score (PYMS)
• Other known GI disorders (except IBS), food intolerances or chronic diseases
• Bowel surgery prior the randomization
• Severe perianal disease (fistulizing or ulcerating), fibrostenotic (B2) or penetrating (B3) disease
• Currently on prednisone/prednisolone for \> 2 weeks
• Pregnant or breastfeeding
• Participating in another study
• Inability to consent

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

The University of British Columbia

Vancouver, British Columbia, V5Z 4H4, Canada

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Kevan Jacobson, MBBCh, FRCP, FRCPC, AGAF, CAGF

  The University of British Columbia

  PRINCIPAL INVESTIGATOR

• Genelle Lunken, BSc, PhD, RD

  The University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevan Jacobson, MBBCh, FRCP, FRCPC, AGAF, CAGF

CONTACT

604-875-2332; kjacobson@cw.bc.ca

Fanny Lemarie, MSc, PhD

CONTACT

604-441-4992; fanny.lemarie@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: January 2, 2026
• Study Start: April 22, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

CA (1)