Modeling Patient Response to a Therapeutic Diet in Crohn's Disease (TDI)
Crohn Disease
About this trial
This is an interventional other trial for Crohn Disease
Eligibility 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) for active symptomatic patients (HBI > 5 to <16) evidence of endoscopic disease activity within six months of enrolment (presence of ulceration ≥5mm ) and for active asymptomatic patients (HBI <5) sonographic findings of intestinal inflammation ≥3mm of bowel wall thickening)
(e) biomarker evidence of inflammation fecal calprotectin at enrolment (FCP
- 250microg/g).
- (f) < OR = 1 small bowel resection,
- (g) ability to provide informed consent
Exclusion Criteria:
- 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) significant chronic disorders such as cardiac disease, renal failure, active pulmonary disease (these factors may influence dietary intake),
- (g) any psychiatric or neurocognitive comorbidity that would limit ability to follow an CD-TDI
- (h) laxative or antibiotics in the past 3 months and
- (i) presence of ostomy.
Sites / Locations
- TRW building, Foothills, University of Calgary
Arms of the Study
Arm 1
Arm 2
Other
No Intervention
CD-TDI
Conventional management
Therapeutic diet Intervention ( CD-TDI )Group : Patients receiving CD-TDI will be offered patient-centered counseling for 12 weeks by a Registered Dietitian (RD) trained in the CD-TDI protocol with the goals of (a) identification and treatment of malnutrition if present, (b) targeted treatment of macro- and micronutrient deficiencies using whole foods;(c) increasing adherence to CD-TDI (d) multivitamin adherence and (e) reduced exposure to dietary antigens (e.g., maltodextrin, carrageenan, other food additives). They will receive a5 face-to-face appointment every 3 weeks with the study RD, and all other weekly appointments, which are 8 in number will be completed by phone.
Conventional Management (Control) Group: CM patients will meet with the RD at baseline, week 7 and week 13 to complete their 24HR food recall twice on different days of the week, followed by a phone few days after the visit to complete the second part of the recall. They will be advised to follow their habitual diet and will be offered the dietary intervention at 14 weeks if they are still experiencing a disease flare