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Diet therapy in Crohn's disease patients

Crohn's Disease

There is an urgent need to understand the role of therapeutic dietary interventions on the treatment of inflammatory bowel disease (IBD).

This study explores the efficacy of a Therapeutic Dietary Intervention (TDI) compared to conventional management (CM) to induce steroid-free clinical remission at week 13 in patients with active, mild-to-moderate Crohn’s Disease.

In this 3-year study, conducted at the University of Calgary and the University of Alberta, eligible participants will be randomly allocated in a 2:1 ratio to either the intervention group (CD-TDI) or conventional management (CM) alone (i.e., control group) for 13-weeks.

Blood and stool samples will be collected to assess the effect of the dietary intervention.

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Participation Requirements

  • Sex:

    Any

  • Eligible Ages:

    18 to 80

Participation Criteria

Inclusion Criteria:
(a) ≥18 years;
(b) diagnosis of mild-to-moderate luminal ileal, ileo-colonic or colonic CD;
(c) active disease with Harvey Bradshaw Index (HBI) <16 at time of recruitment;
(d) biomarker evidence of inflammation fecal calprotectin at enrolment (FCP ≥250microg/g).
(e) < OR = 1 small bowel resection,
(f) ability to provide informed consent
(g) for symptomatic patients (HBI >5 to <16) mandatory fixed steroid taper that includes prednisone 30mg daily for one week, and taper by 5mg per week and discontinuation by week 6.
Exclusion Criteria:
(a) HBI >16 at time of recruitment;
(b) fecal calprotectin < 250 microg/mg within 1 month prior to study enrollment;
(c) patients with upper GI tract CD;
(d) evidence of perianal or fistulizing disease;
(e) >1 bowel surgery;
(f) laxative or antibiotics in the past 3 months
(g) presence of ostomy.
(h) COVID-19 in last 8 weeks or develop during the study
(i) pregnancy or breastfeeding. Pregnancy test will be done on women of child bearing age

Study Location

University of Alberta
University of Alberta
Edmonton, Alberta
Canada

Contact Study Team

Primary Contact

Simona Veniamin

[email protected]
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Study Sponsored By
University of Alberta
Participants Required
More Information
Study ID: Pro00090772