Crohn Disease
Conditions
Keywords
diet, inflammation, microbiome
Brief summary
The goal of the study is to test the efficacy of a dietary intervention in inducing clinical response and remission for patients with Crohn's disease in a randomized controlled trial. The intervention diet: DAIN has been adapted from the Inflammatory Bowel Disease Anti-Inflammatory Diet or IBD-AID™ taking into account the food availability and preferences of Puerto Ricans. DAIN also includes traditional foods commonly consumed in the typical Puerto Rican diet while maintaining the fundamental components of the IBD-AID™.
Detailed description
Crohn's disease is a chronic recurrent inflammatory disorder of the gastrointestinal that results from an inappropriate inflammatory response to an altered gut microbiome (i.e., dysbiosis). Diet is the main driver of microbiome composition. Diet also has been increasingly recognized as a cost-effective strategy to induce remission in pediatric and adult patients with Crohn's disease but diets that can substitute traditional and locally available foods among Puerto Ricans have not been explored. DAIN, a newly created dietary program, incorporates an extensive patient curriculum of recipes and menus adapted to the local availability and food preferences of Puerto Rican patients with Crohn's disease. This study aims to address three questions: whether DAIN a diet adapted to Puerto Rican patients with Crohn's disease, can: 1) induce clinical response and remission; 2) change the inflammatory tone, and 3) revert dysbiosis in Crohn's disease patients. Participants will be randomized 1:1 ratio into two arms: * Arm 1 Crohn's disease patients + DAIN (Experimental): this group of patients will participate in ten weeks of DAIN intervention (From week 1 to week 10) * Arm 2 Crohn's disease patients no intervention (Control): this group of patients will not participate in the DAIN dietary intervention and will continue the usual diet. Participation in the study lasts for 15 weeks with four-time points: week 0 (baseline), week 6, week 10, and week 14. At each time point, all subjects will complete a series of questionnaires to assess overall health, Crohn's disease activity, and dietary compliance. Blood and stool samples will be also collected at home at each time point. Samples will be either shipped or brought to the Research Unit at the Inflammatory Bowel Disease Clinic at the University of Puerto Rico. The primary outcome is Improvement of health-related quality of life. Secondary outcomes are: (i) reduction of inflammation, (ii) changes in the gut microbiome, (iii) clinical response and remission,and (iii) dietary compliance.
Interventions
OTHERDAIN
Participants in the experimental arm will have access to the newly created DAIN curriculum including menus, recipes, and recorded 'how to' recipes. Participants in the experimental arm will also have once-per-week dietary counseling with DAIN-trained nutritionists and monthly cooking classes with a DAIN-trained chef.
Sponsors
University of Massachusetts, Worcester
University of Puerto Rico
The Leona M. and Harry B. Helmsley Charitable Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
All staff collecting data (e.g., dietary assessment) or assaying samples (e.g., fecal calprotectin, cytokines, sequencing) including the PI's, will be blinded to diet group assignments.
Intervention model description
Randomized intervention trial in adults with Crohn's disease.
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 21 to 65 years old * Confirmed CD diagnosis with sCDAI \<450 (includes values ranging from remission, mild to moderate activity) * Moderate to severe impaired QoL (sIBDQ\<60) * Stable doses of medications are screened; thiopurines, natalizumab, methotrexate (12 weeks), anti-tumor necrosis factor (TNF), ustekinumab, vedolizumab (8 weeks), 5-aminosalicylic acid (5-ASA) (2 weeks), steroids (1 week) * Willingness and capacity to significantly change diet (arm 1) * Willing and able to comply with specimen collection and other study procedures, and to complete the study
Exclusion criteria
* Ostomy * Use of Specific Carbohydrate Diet of IBD-AID™ within 4 weeks of screening * Use of prescribed probiotics within 4 weeks of screening * \> 20mg prednisone or equivalent * Recent C. difficile colitis * Pregnancy * Presence of symptomatic or significant structure or history of obstruction in the past 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of health-related quality of life | Week 0, 6, 10, 14 | Improvement of health-related quality of life (increase of the short Inflammatory Bowel Disease Questionnaire score (SIBDQ)). The SIBDQ scores range between 10 and 70 points. A slightly impaired quality of life is indicated by scores from 60 to 70 points, moderately impaired quality of life from 45 to 60 points, and severely impaired quality of life from 10 to 45 points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Inflammation | Week 0, 6, 10, 14 | Changes in inflammation will be determined by levels of calprotectin in stools and C-reactive protein (CRP) in the blood. Both stool and blood will be collected at each time point. Decreased levels of fecal calprotectin and CRP indicate a decrease in inflammation and vice versa. |
| Gut Microbiome changes | Week 0, 6, 10, 14 | Gut microbiome changes related to the dietary intervention will be assessed by metagenomic shotgun sequencing of stool samples collected at each time point. |
| Dietary compliance | Week 0, 6, 10, 14 | DAIN Dietary compliance will be evaluated by calculating the Healthy Eating Index (HEI) score from the assessment tools: 24-Hour Dietary Recalls (24HDRs) and Food Frequency Questionnaires, surveyed at each time point. The HEI is composed of 13 diet components: total fruits, whole fruits, total vegetables, greens and beans, dairy, total protein foods, seafood and plant proteins, fatty acids, refined grains, whole grains, sodium, added sugars, and saturated fats. A minimum number of servings per component have been established, and the scoring of the HEI components is based on these established values. The total maximum score is equal to 100. Higher values represent closer compliance with DAIN. |
| Clinical response and remission | Week 0, 6, 10, 14 | Clinical response and clinical remission will be assessed by reduction of the Short Crohn's Disease Activity Index or SCDAI. Scores range from 0 to 600 with different. A score less than 150 indicates remission, a score between 150-219 indicates mild activity, a score from 220 and 450 indicates moderate activity, and a score greater than 450 indicates severe activity. |
Countries
Puerto Rico, United States
Contacts
PRINCIPAL_INVESTIGATORAna L Maldonado-Contreras, PhD
University of Massachusetts Chan Medical School
Outcome results
None listed