CD-TDI for Crohn's Disease (TDI Trial)

N/A

Waitlist Available

Led By Maitreyi Raman, MD

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 7 and 13 weeks for fecal calprotectin and baseline and week 13 for sonographic findings

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a Crohn's Disease Therapeutic Dietary Intervention can help induce remission in patients with active, mild-to-moderate luminal Crohn's Disease.

Eligible Conditions

Crohn's Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 7 and 13 weeks for fecal calprotectin and baseline and week 13 for sonographic findings

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 7 and 13 weeks for fecal calprotectin and baseline and week 13 for sonographic findings

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 7 and 13 weeks for fecal calprotectin and baseline and week 13 for sonographic findings for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bowel wall thickness on sonographic findings and Fecal calprotectin: Change is being assessed.

Fecal calprotectin: Change is being assessed.

Harvey Bradshaw Index (HBI): Change is being assessed

Secondary study objectives

Albumin: Change is being assessed

CRP: Change is being assessed

Cr: Change is being assessed

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CD-TDIExperimental Treatment1 Intervention

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.

Group II: Conventional managementActive Control1 Intervention

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

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