Modeling Patient Response to a Therapeutic Diet in Crohn's Disease

Summary

Participation Requirements

Description

OBJECTIVES: Primary objectives A) Symptomatic patients at the time of recruitment: Harvey Bradshaw Index (HBI) >5 to <16 To compare the proportion of patients in each study group at week 13 who are in corticosteroid-free (CF) clinical remission as measured by a Harvey Bradshaw Index (HBI) of <5 (pri...

OBJECTIVES: Primary objectives A) Symptomatic patients at the time of recruitment: Harvey Bradshaw Index (HBI) >5 to <16 To compare the proportion of patients in each study group at week 13 who are in corticosteroid-free (CF) clinical remission as measured by a Harvey Bradshaw Index (HBI) of <5 (primary endpoint) To compare the proportion of patients in each study group at week 13 who are in biochemical remission as measured by a fecal calprotectin (FCP) of <250ug/g (primary endpoint). B) Asymptomatic patients with active disease at the time of recruitment: Harvey Bradshaw Index (HBI) <5 To compare the proportion of patients in each study group at week 13 who are in biochemical remission as measured by a fecal calprotectin (FCP) of <250ug/g (primary endpoint). To compare the proportion of patients in each study group at week 13 who are in clinical remission as measured by sonographic findings of inflammation (Bowel Wall thickening ? 3mm). Secondary Hypothesis: The aim of the secondary objectives are to examine whether the dietary intervention has a significant effect on the gut microbiota and SCFAs in patients and whether this is associated with the intervention and disease recurrence at or before 13 weeks. The aim is also to examine whether the intervention has a significant effect on health-related quality of life. To identify the presence of within and between-group differences in microbial diversity, microbial composition, and abundance of short-chain fatty acids (SCFA) and SCFA-producing bacteria at baseline and 13weeks. To identify the presence of within and between-group differences in fecal SCFA concentrations at baseline and 13 weeks. To compare the proportion of patients in each study group at week14 that achieve clinical response (decrease in HBI>3points) METHODS: Randomized controlled trial design: This 3-year study, investigator-blinded, RCT (N=102) at the University of Calgary (UoC). 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. Conventional Management (Control) Group: CM patients will meet with the RD at baseline, week 7 and week 13 to complete their 24 hour 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. 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.

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