Crohn DiseaseTDINCT04596566
Modeling Patient Response to a Therapeutic Diet in Crohn's Disease
A study testing Therapeutic diet Intervention in people with Crohn Disease, run by University of Calgary at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Therapeutic diet Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteCanada
- Study dates
- 20 Feb 2020to 12 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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
- 250microg/g).
- (f) < OR = 1 small bowel resection,
- (g) ability to provide informed consent
Who cannot join
- 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),
Show all 9Show fewer
- (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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
TRW building, Foothills, University of Calgary
Calgary, Alberta, T2N 4Z6
About this study
Official title: Can Personalized Diet Therapy Favourably Impact Disease Severity in Patients With Crohn's Disease
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.
Read the detailed description
OBJECTIVES:
Primary objectives
- 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).
- 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.
- Conditions
- Crohn Disease
- Being tested
- Therapeutic diet Intervention
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic diet InterventionOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Microbiome composition will be measured using shotgun metagenomic sequencing
Measured: baseline, 7 and 13 weeks
Short chain fatty acids: Change is being assessed
Concentrations of fecal SCFA will be measured according to our previously published protocol. Fecal samples (150 mg) will be added to 1000 µL of 0.005 M aqueous sodium hydroxide containing internal standard (D3 caproic acid), and homogenized for 3 cycles using Fast Prep-24TM homogenizer (MP Biomedicals, Santa Anna, USA). The supernatant will be collected after centrifugation at 14,000 x g for 20 min. The derivatization using propyl chloroformate and analysis of the SCFAs using gas chromatography-mass spectrometry (GC-MS/MS) will be done as previously described
Measured: baseline, 7 and 13 weeks
Health related quality of life: Change is being assessed.
Health-related quality of life will be measured using the 12-item short form-12. It comprises of two components physical health and mental Health. Scores range from 0 to 100, where a zero score indicates the lowest level of health and 100 indicates the highest level of health.
Measured: baseline, 7 and 13 weeks
Subjective global assessment: Change is being assessed
subjective global assessment is a validated tool to determine malnutrition status in patients with chronic disease. It is scored as A: Well-nourished; B: Mildly/moderately malnourished; C:Severely malnourished. "A" mean normal; "B" means some progressive nutritional loss; "C": means there is evidence of wasting and progressive symptoms
Measured: baseline, 7 and 13 weeks
Dietary intake: Change is being assessed
Dietary intake and supplement use will be assessed at baseline (week 0),week 7 and week 13 using 2-24 Hour recalls using the multipass method.
Measured: baseline, 7 and 13 weeks
Sedentary time: Change is being assessed
Sedentary time, will be assessed by the ActivPAL® inclinometer (PALTechnologies, Glasgow). ActivPAL® monitors are the most validated and widely used devices for measuring sitting, standing, and moving/stepping (and transitions in between). Inclinometers are small electronic devices worn discretely on the upper thigh. They measure duration and frequency of time spent sitting, standing and stepping (light ambulation), and number of postural changes. Materials: To capture all activities occurring throughout the day the ActivPAL® (captures lying, sitting, standing, and stepping).
Measured: Baseline and week 13
CRP: Change is being assessed
C-reactive protein (mg/L)
Measured: Baseline and week 13
Ferritin: Change is being assessed
Ferritin (Microgram/Litre)
Measured: Baseline and week 13
Albumin: Change is being assessed
Albumin (g/L)
Measured: Baseline and week 13
Vitamin D: Change is being assessed
Vitamins D (25OHD3) (nmol/L)
Measured: Baseline and week 13
Cr: Change is being assessed
Creatinine( µmol/L)
Measured: Baseline and week 13
Electrolytes: Change is being assessed
Electrolytes: Sodium (Na), potassium (K), chloride (Cl) mmol/L
Measured: Baseline and week 13
Hb: Change is being assessed
Hemoglobin (Hb) (g/L)
Measured: Baseline and week 13
Platelet: Change is being assessed
Platelet count (/L)
Measured: Baseline and week 13
WBC: Change is being assessed
White blood cell count (WBC) (/L)
Measured: Baseline and week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start20 Feb 2020
- Primary completion12 Feb 2023 (estimated)
- Study completion12 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Crohn's and Colitis Foundation, University of Alberta, University of Guelph, University of British Columbia, Alphabiomics, University of Birmingham
- Responsible party
- Principal investigator, Maitreyi Raman, University of Calgary
- Investigators
- Maitreyi Raman, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596566
- Sponsor's protocol ID
- REB19-0402
- Acronym
- TDI
- Status last verified
- Oct 2020
- First submitted
- 6 Feb 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers outside of the study team.
Publications
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). Ther Adv Gastroenterol. 2025 Feb 16;18:17562848251314827. doi: 10.1177/17562848251314827. eCollection 2025.
PubMed 39963251Raman 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.
PubMed 35046093
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Personalized Diet Therapy Favourably Impact Disease Severity in Patients With Crohn's Disease
- ClinicalTrials.gov ID
- NCT04596566
- Acronym / sponsor ID
- TDI / REB19-0402
- Conditions
- Crohn Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Crohn's and Colitis Foundation, University of Alberta, University of Guelph, University of British Columbia, Alphabiomics, University of Birmingham
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 12 Feb 2023 (estimated)
- Study completion
- 12 Jun 2023 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
Primary objectives
- 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).
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CD-TDI | Other | Other: Therapeutic diet InterventionTherapeutic 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. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- (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
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic diet InterventionThe 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 | Other | CD-TDI |
Primary outcome
Fecal calprotectin: Change is being assessed.
Time frame: baseline, 7 and 13 weeks.
<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.
Harvey Bradshaw Index (HBI): Change is being assessed
Time frame: baseline, 7 and 13 weeks.
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.
Bowel wall thickness on sonographic findings and Fecal calprotectin: Change is being assessed.
Time frame: baseline, 7 and 13 weeks for fecal calprotectin and baseline and week 13 for sonographic findings
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).
15 secondary outcomes
Fecal Microbiota Sequencing: change is being assessed.
Time frame: baseline, 7 and 13 weeks
Short chain fatty acids: Change is being assessed
Time frame: baseline, 7 and 13 weeks
Health related quality of life: Change is being assessed.
Time frame: baseline, 7 and 13 weeks
Subjective global assessment: Change is being assessed
Time frame: baseline, 7 and 13 weeks
Dietary intake: Change is being assessed
Time frame: baseline, 7 and 13 weeks
Sedentary time: Change is being assessed
Time frame: Baseline and week 13
CRP: Change is being assessed
Time frame: Baseline and week 13
Ferritin: Change is being assessed
Time frame: Baseline and week 13
Albumin: Change is being assessed
Time frame: Baseline and week 13
Vitamin D: Change is being assessed
Time frame: Baseline and week 13
Cr: Change is being assessed
Time frame: Baseline and week 13
Electrolytes: Change is being assessed
Time frame: Baseline and week 13
Hb: Change is being assessed
Time frame: Baseline and week 13
Platelet: Change is being assessed
Time frame: Baseline and week 13
WBC: Change is being assessed
Time frame: Baseline and week 13
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Derived from this study: PubMed 39963251Haskey 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). Ther Adv Gastroenterol. 2025 Feb 16;18:17562848251314827. doi: 10.1177/17562848251314827. eCollection 2025.
- Derived from this study: PubMed 35046093Raman 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.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers outside of the study team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maitreyi Raman, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic diet Intervention in people with Crohn Disease, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal calprotectin: Change is being assessed. (time frame: baseline, 7 and 13 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04596566, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.