Nutritional Therapy + Anti-TNFα for Crohn's Disease

(DISPENSE-T Trial)

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

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must be taking: Infliximab

Must not be taking: Antibiotics, Laxatives, Probiotics

Disqualifiers: Vegetarians, Malnutrition, GI disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

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

Principal Investigator

The University of British Columbia

Genelle Lunken, BSc, PhD, RD

Principal Investigator

The University of British Columbia

Are You a Good Fit for This Trial?

This trial is for pediatric patients with Crohn's Disease, a type of Inflammatory Bowel Disease. It aims to help children who face growth issues and frequent hospital visits due to their condition. The study requires participants who are starting infliximab treatment.

Inclusion Criteria

Evidence of active inflammation: FCP level > 250 µg/g and/ or CRP > 5 mg/L or ESR > 20 mm/hr

Able and willing to follow dietary recommendations

Willing to enroll in the CIDsCaNN Network study

Exclusion Criteria

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 months

Multiple visits for baseline sample and data collection

Pre-randomization

Baseline sample and data collection, including optional genetic testing

Up to 4 months

Multiple visits for sample collection and assessments

Treatment

Participants receive infliximab therapy with or without mCDED dietary intervention

12 months

Regular visits for IFX infusion and dietary assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Final assessments and data collection

What Are the Treatments Tested in This Trial?

Interventions

• Crohn's Disease Exclusion Diet (CDED)
• Infliximab

Trial Overview

The trial tests the combination of infliximab (an anti-TNFα medication) with the Crohn's Disease Exclusion Diet (CDED). It evaluates if this nutritional therapy alongside the drug can improve treatment responses in children with Crohn's disease.

How Is the Trial Designed?

Group I: IFX + mCDED Experimental Treatment 1 Intervention

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

Group II: IFX Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+