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

NCT04596566 | Unknown DMC

• 1 other identifier: REB19-0402
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND: There is an urgent need to understand the role of therapeutic dietary interventions on the treatment of inflammatory bowel disease (IBD). Although nutritional observational studies have examined associations between diet and the development of IBD, the relationship between dietary components and disease relapse is lacking. Despite the lack of a well-defined relationship between dietary determinants and disease relapse, patients with IBD frequently have a strong belief that diet has a key role in controlling the course of their disease, and maybe a trigger of disease relapse. This proposed randomized controlled trial (RCT) explores the efficacy of a Crohn's Disease (CD) Therapeutic Dietary Intervention (TDI) compared to conventional management (CM) to induce steroid-free clinical remission at week 13 in patients with active, mild-to-moderate luminal CD. For asymptomatic patients with active disease, efficacy of the diet will be explored by using fecal calprotectin and sonographic findings Rationale: Our team of investigators recently compared a representative healthy population to patients with CD and identified CD patients have: lower intakes of polyunsaturated and monounsaturated fats and multiple micronutrients (vitamins C, D, thiamine magnesium, phosphorus, zinc, potassium), and; few patients with CD met criteria for an anti-inflammatory dietary pattern. Since the diet is a modifiable potential risk factor for disease recurrence in IBD, there is a strong rationale for the investigation of diet on disease course. Additionally, patients have expressed strong interest in identifying the relationships between diet and disease, therefore assigning priority to this theme is an opportunity to advance patient-oriented care.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (3)

• Fecal calprotectin: Change is being assessed.

  \<250 ug/mg with at least 100ug/g decline from baseline. FCP is a test used to detect inflammation in the colon and is associated with disease activity and severity.

  baseline, 7 and 13 weeks.

• Harvey Bradshaw Index (HBI): Change is being assessed

  HBI is a validated, non-invasive measure of disease activity captured through a symptom questionnaire and is a surrogate to endoscopic assessment to determine disease severity. HBI minimum value is "0" and maximum no limit. HBI \< 5 is used in this study to indicate clinical remission. HBI\> 16 means severe disease activity. Higher scores means worse outcomes. Based on experience with past recruitment for clinical trials, endoscopic assessment is not feasible due to access and patient acceptance.

  baseline, 7 and 13 weeks.

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

  For asymptomatic patients with active disease at the time of recruitment (HBI \<5 ) a combined primary endpoint using both FCP \<250 ug/mg with at least 100ug/g decline from baseline and ultrasound findings of bowel wall thickening will be used.( ≤ 3mm).

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

Secondary Outcomes (15)

• Fecal Microbiota Sequencing: change is being assessed.

  baseline, 7 and 13 weeks

• Short chain fatty acids: Change is being assessed

  baseline, 7 and 13 weeks

• Health related quality of life: Change is being assessed.

  baseline, 7 and 13 weeks

• Subjective global assessment: Change is being assessed

  baseline, 7 and 13 weeks

• Dietary intake: Change is being assessed

  baseline, 7 and 13 weeks

Study Arms (2)

CD-TDI

OTHER

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.

Other: Therapeutic diet Intervention

Conventional management

NO 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

Interventions

Therapeutic diet Intervention OTHER

The CD-TDI will incorporate global principles of the Mediterranean Diet (MD) refined to inform specific food choices based on our pilot data results and published literature reported mechanisms of mitigating inflammation in IBD. Patient compliance will be measured in three ways: 1) Mediterranean diet score checklists completed every 3 weeks at the face-to-face visits; 2) goal attainment scores captured weekly to identify the goals set, and the goals attained 47; and 3) fatty acids profiled from red blood cells to identify if fat intake reflects CD-TDI fat recommendations: 35% total calories from fat, 15% from MUFA, 13% from SFA and 6% from PUFA with a 8 n6:n:3 ratio of 8:1

CD-TDI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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
• microg/g).
• (f) \< OR = 1 small bowel resection,
• (g) ability to provide informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead
• Crohn's and Colitis Foundation: collaborator
• University of Alberta: collaborator
• University of Guelph: collaborator
• University of British Columbia: collaborator
• Alphabiomics: collaborator
• University of Birmingham: collaborator

Study Sites (1)

TRW building, Foothills, University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

Related Publications (2)

• Haskey N, Letef C, Sousa JA, Yousuf M, Taylor LM, McKay DM, Ma C, Ghosh S, Gibson DL, Raman M. Exploring the connection between erythrocyte membrane fatty acid composition and oxidative stress in patients undergoing the Crohn's disease Therapeutic Diet Intervention (CD-TDI). Therap Adv Gastroenterol. 2025 Feb 16;18:17562848251314827. doi: 10.1177/17562848251314827. eCollection 2025.

  PMID: 39963251 DERIVED

• Raman M, Ma C, Taylor LM, Dieleman LA, Gkoutos GV, Vallance JK, McCoy KD, Lewis I, Jijon H, McKay DM, Mutch DM, Barkema HW, Gibson D, Rauch M, Ghosh S. Crohn's disease therapeutic dietary intervention (CD-TDI): study protocol for a randomised controlled trial. BMJ Open Gastroenterol. 2022 Jan;9(1):e000841. doi: 10.1136/bmjgast-2021-000841.

  PMID: 35046093 DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Maitreyi Raman, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor, Director Clinician Investigator Program (CIP), Medical Director Alberta's Collaboration of Excellence for Nutrition in Digestive Diseases (Ascend) , Medical Director Nutrition Services

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: October 22, 2020
• Study Start: February 20, 2020
• Primary Completion: February 12, 2023
• Study Completion: June 12, 2023
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)