Diet Therapy for Crohns Patients
Summary
It can be hard to understand how what you eat can affect Crohn’s Disease. Some research has shown food can help control Crohn’s. More research needs to be done to understand how foods can help improve Crohn’s. The purpose of this study is to see if the food people eat affects your Crohn’s disease activity. The study will also look at how different foods affect the bacteria in your gut. The doctors in the GI clinic at the Foothills Hospital support this study and want to test new treatments to help patients with Crohn’s.
The study takes 14 weeks to complete.
If you join this study, you will be assigned to either the “conventional management” (CM) group or the “therapeutic diet intervention” (CD-TDI) group.
If you are in the CM group, you 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. You will be advised to follow your habitual diet. At the end of the study, you will be offered the dietary intervention if you are still experiencing a disease flare. If you are not experiencing a flare you will be offered 2 appointments with the dietician for general counselling.
Patients receiving CD-TDI will be offered patient-centred counselling for 12 weeks by a Registered Dietitian (RD) trained in the CD-TDI protocol. The dietician will conduct the interview using phone or Microsoft Teams every week. Your first meeting will take around 60 minutes. and follow-up meetings will take 15 minutes. The focus will be on using foods to reduce inflammation in your gut. You will also be given access to the LyfeMD mobile application. This application will help you track the foods that you are eating and record you symptom score weekly. You will be asked to fill nutrition assessment form at baseline, week 7 and week 13.
For both groups treatment for your Crohn’s will continue as usual with your GI doctor.
Eligibility
Eligible gender: Male, Female, Transgender, Other
Eligible ages: 18 to 80
Accepts healthy participants: Yes
Inclusion criteria:
CD patients inclusion criteria:
(a) ≥18 years;
(b) diagnosis of mild-to-moderate luminal ileal, ileo-colonic or colonic CD i
(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
(i) 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:
CD patients 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) 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.
(k) COVID-19 in last 8 weeks or develop during the study
(l) pregnancy or breastfeeding. Pregnancy test will be done on women of child bearing a
age
Participate
Fill out the following form if you want to participate in this research
Collection of personal information
Your personal information is collected under
the authority of section 33(c) of the Freedom of Information and Protection of Privacy Act. If
you have any questions about the collection or use of this information, please visit our
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Additional information
Contact information
Research coordinator: 403-592-5231 or ascend@ucalgary.ca
Principal investigator:
Maitreyi Kothandaraman
Clinical trial:
Yes
REB-ID:
REB19-0402