Can Personalized Diet Therapy Favourably Impact Disease Severity in Patients With Crohn's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Bowel wall thickness on sonographic findings and Fecal calprotectin: Change is being assessed.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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
排除标准
- •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.
结局指标
主要结局
Bowel wall thickness on sonographic findings and Fecal calprotectin: Change is being assessed.
时间窗: 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).
Fecal calprotectin: Change is being assessed.
时间窗: 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
时间窗: 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.
次要结局
- Hb: Change is being assessed(Baseline and week 13)
- WBC: Change is being assessed(Baseline and week 13)
- 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)
- CRP: Change is being assessed(Baseline and week 13)
- Vitamin D: Change is being assessed(Baseline and week 13)
- Cr: Change is being assessed(Baseline and week 13)
- Electrolytes: Change is being assessed(Baseline and week 13)
- Platelet: Change is being assessed(Baseline and week 13)
- 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)
- Sedentary time: Change is being assessed(Baseline and week 13)
- Ferritin: Change is being assessed(Baseline and week 13)
- Albumin: Change is being assessed(Baseline and week 13)
研究者
Maitreyi Raman
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
University of Calgary