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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

TDI Trial 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.

TDI Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Albumin: Change is being assessed

CRP: Change is being assessed

Cr: Change is being assessed

+12 more

TDI 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of BirminghamOTHER

282 Previous Clinical Trials

10,753,582 Total Patients Enrolled

AlphabiomicsUNKNOWN

University of GuelphOTHER

80 Previous Clinical Trials

9,874 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What results are researchers expecting to see from this experiment?

"The primary aim of this trial, monitored over an initial period and then at 7-week intervals for 13 weeks, is to measure changes in bowel wall thickness as assessed by sonography and fecal calprotectin. Secondary objectives include evaluating the impact of dietary intake on white blood cell count (WBC) (/L), platelet count (/L), and supplement use via two 24 hour recalls using the multipass method."

Answered by AI

Is this research initiative recruiting new participants?

"The clinical trial referenced on the website of clinicaltrials.gov is not recruiting at this moment, as its last update was made in October 2020. Nonetheless, 253 other studies are currently enrolling participants."

Answered by AI

Recent research and studies

BMJ Open GastroenterologyJournal

Crohn’s Disease Therapeutic Dietary Intervention (CD-TDI): Study Protocol for a Randomised Controlled Trial

Raman, Maitreyi, Christopher Ma, Lorian M Taylor, Levinus A Dieleman, Georgios V Gkoutos, Jeff K Vallance, Kathy D McCoy, et al.. 2022. “Crohn’s Disease Therapeutic Dietary Intervention (CD-TDI): Study Protocol for a Randomised Controlled Trial”. BMJ Open Gastroenterology. BMJ. doi:10.1136/bmjgast-2021-000841.

clinicaltrials.govStudy

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

Maitreyi Raman 2020. "Modeling Patient Response to a Therapeutic Diet in Crohn's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04596566.

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