Nutritional Therapy + Anti-TNFα for Crohn's Disease
(DISPENSE-T Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if combining the Crohn's Disease Exclusion Diet (CDED) with infliximab, an anti-TNFα medication, helps children with Crohn's disease improve their symptoms and manage them more effectively. Crohn's disease causes inflammation in the digestive tract, leading to pain and other issues. The trial will compare children who begin both infliximab and the diet immediately to those who only start infliximab. Children with moderate to severe Crohn's disease for less than a year, who have not tried biologic treatments before, may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to explore innovative treatment combinations for better symptom management.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but you must be on a stable dose of AZA or Methotrexate at the start. If you're on steroids or exclusive enteral nutrition, it should be for less than 2 weeks (or 4 weeks for established disease) before joining.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using infliximab, a medication that reduces inflammation, along with the Crohn's Disease Exclusion Diet (CDED) is generally safe. The FDA has already approved infliximab for treating Crohn's disease, and its safety has been well-studied. Previous studies have found that the CDED is well-tolerated and significantly improves symptoms for many people.
Specifically, research has found that a large number of patients on the CDED experience major symptom relief. For instance, 70% of participants showed improvement after six weeks. Another study found that nearly 90% of patients reached remission, meaning their symptoms improved greatly, within 12 weeks on the diet.
These findings suggest that combining infliximab with the CDED is promising and generally safe for people with Crohn's disease. However, like any treatment, it may not work for everyone, so discussing any concerns with a healthcare provider is important.12345Why are researchers excited about this trial?
Researchers are excited about combining nutritional therapy with infliximab for Crohn's disease because it offers a fresh approach to managing the condition. Infliximab is already a well-known anti-TNFα drug used to reduce inflammation, but combining it with a modified Crohn's disease exclusion diet (mCDED) could enhance its effectiveness. Unlike standard treatments that focus solely on medication, this approach integrates dietary changes, potentially offering a more holistic way to control symptoms and improve patient outcomes. The anticipation is that this combination could lead to better disease management and improve quality of life for patients with Crohn's disease.
What evidence suggests that this trial's treatments could be effective for Crohn's disease?
Research shows that combining infliximab, a type of medication, with the Crohn's Disease Exclusion Diet (CDED) can help children with Crohn's disease feel better. In this trial, participants in one arm will follow a modified version of the CDED (mCDED) for 6 months while starting their infliximab therapy. One study found that up to 94.7% of children following the CDED were symptom-free within 12 weeks. Another study found that using infliximab with partial enteral nutrition (a diet partly made up of liquid nutrients) helps both in the short term and for long-term control of the disease. The CDED is also easy to follow and effective, with about 85% of children showing improvement by week 6. These findings suggest that this combined approach could be a promising way to manage Crohn's disease symptoms more effectively.12346
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-randomization
Baseline sample and data collection, including optional genetic testing
Treatment
Participants receive infliximab therapy with or without mCDED dietary intervention
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Experimental Treatment
Active Control
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
Participants will initiate their infliximab therapy as part of their routine care
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of British Columbia
Lead Sponsor
Citations
Effects of Modified Crohn's Disease Exclusion Diet as ...
The clinical remission rates were 89.5% and 94.7% at 6 and 12 weeks post-treatment, respectively, in the CDED group and 88.5% and 84.6%, ...
The efficacy of infliximab combined with partial enteral ...
Infliximab treatment combined with partial enteral nutrition is beneficial for both short-term clinical response and long-term endoscopic remission in CD ...
Combining Nutritional Therapy and Anti-TNFα Treatment in ...
Nutritional therapies , especially the Crohn's Disease Exclusion Diet (CDED), may help improve treatment outcomes. This study will assess ...
Modified Crohn's Disease Exclusion Diet Maintains ...
found that CDED induced remission in 26.7% of moderate-to-severe cases compared with 73.3% in mild cases. In our study, the diet was less ...
Crohn's Disease Exclusion Diet: A Comprehensive Review of ...
The CDED + PEN vs EEN showed superior tolerability and equal effectiveness in inducing remission at week 6, with response rates around 85%.
Modified Crohn's Disease Exclusion Diet Maintains ...
Notably, 78% of CDED responders at week 8 sustained remission through week 24, supporting CDED as a long-term management option for early responders. However, ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.