NCT04779762

Stelara and Diet Trial for Crohn"s Disease

Stelara and CDED Diet Trial for Crohn"s Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Wolfson Medical Center · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Dietary therapy involving the Crohn's disease exclusion diet (CDED) is an evolving strategy to target the microbiome and innate immunity in order to reduce inflammation and promote healing. The goal of the current pilot study is to evaluate the added benefit of treatment with Ustekinumab combined with CDED in anti TNF exposed patients compared to treatment with Ustekinumab alone in term of achieving remission.

Detailed description

The induction period is crucial for a patient's response to biologic therapy but also for maintenance of remission, as simple as it sounds, maintenance of remission requires remission. Biological medications using a single monoclonal antibody directed target, seem to be effective only for a segment of the population with Crohn's disease Dietary therapy is highly effective in children and induces remission in approximately 60% of young adults with uncomplicated luminal disease. It was shown to shift the microbiome away from Proteobacteria towards Firmicutes, and to decrease intestinal permeability (i.e improvement in leaky gut). Dietary therapy is widely used in children and both exclusive enteral nutrition (EEN) and the Crohn's disease exclusion diet were highly effective for induction of remission and reduction in inflammation in children in a multinational randomized controlled trial (Levine A, Gastroenterology 2019). Recently a prospective randomized controlled trial in biologic naïve adults demonstrated clinical remission in 62% of adults by 6 weeks (Yanai H, UEG Week 2020). A two week course of EEN in adults was effective for improvement of symptoms and reduction in inflammation (Wall CL Inflamm Intest Dis 2018). Xu et al demonstrated clinical remission in 52 and 47% of two adult cohorts (n=104) using EEN for induction of remission (Xu Y, Therap Adv Gastroenterol 2019). Taken together, these studies suggest that dietary therapy could act as a bridge to biologic effect and have a synergistic effect on the disease.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
OTHER	Crohn's disease exclusion diet (CDED)	Dietary therapy for Crohn's disease
DRUG	Ustekinumab Injection [Stelara]	Drug for Crohn's disease

Timeline

• Start date: 2022-01-01
• Primary completion: 2025-01-01
• Completion: 2026-01-01
• First posted: 2021-03-03
• Last updated: 2021-03-03

Locations

1 site across 1 country: Israel