SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis

Study Overview
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Brief Summary
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Although patients and physicians have shown tremendous interest in the effect of diet on ulcerative colitis, there is a lack of significant evidence for providers to make practical recommendations with. In this study, the investigators hope to find out if dietary therapy by either the Specific Carbohydrate Diet (SCD) or the Mediterranean diet will help improve ulcerative colitis symptoms for patients with mild to moderately active disease. In addition, the investigators will compare disease activity and changes in the intestinal bacterial composition in the colon that occur with the Mediterranean or the SCD diet in active ulcerative colitis. This study is proposed as a single-site randomized trial consisting of 10 study visits to Massachusetts General Hospital (MGH) over 12 weeks. Participants in this study will be randomly assigned to the SCD or Mediterranean diet. The investigators ask that participants exclusively consume their assigned diet for 6 weeks, with all meals and snacks prepared by the metabolic kitchen within MGH. Participants will need to pick up food from MGH every 5-7 days, and will meet with a study dietitian before they begin and weekly during the diet therapy. There will be a screening visit to determine eligibility for the study, as well as study visits at weeks 0, 1, 2, 4, 6, and a 10 week follow-up at MGH, in which participants will fill out questionnaires. Participants will need to provide stool samples at screening, week 6, and week 10. In addition, blood will be drawn at week 0 and week 6, and if participants are getting a clinically-indicated colonoscopy at the time of screening, up to eight research biopsies may be collected during the procedure.

Detailed Description
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This randomized, parallel-group feeding study will examine the influence of Mediterranean and SCD diets on gut microbiota, luminal inflammation, and disease-specific clinical indices in patients with mild to moderate ulcerative colitis (UC). 50 patients will be randomized to follow either the SCD or Mediterranean diet in a 1:1 ratio. Once informed consent is obtained, subjects will enter a 2-week screening period. Eligible subjects will be enrolled in the feeding treatment for 6 weeks followed by an additional follow-up visit at 10 weeks (4 weeks after feeding treatment completion). The total time to complete the study is 12 weeks. The metabolic kitchen within the Metabolism and Nutrition Research Center at MGH Translational and Clinical Research (TCRC) Unit will be responsible for preparing and packaging food for participants to pick up, as well as performing all necessary nutritional assessments. Participants will be provided with 3 meals and 2 snacks a day during the 6-week dietary intervention. Patient menus will be identical in each diet and will rotate on a 3-day basis. Total calories for each diet will be tailored according to each participant's body composition.

Official Title
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Specific Carbohydrate Diet vs. Mediterranean Diet Therapy in Ulcerative Colitis - A Clinical Trial

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Other: Specific Carbohydrate Diet
* Other: Mediterranean Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of active ulcerative colitis for at least 3 months before screening Ulcerative colitis confirmed by colonoscopy or flexible sigmoidoscopy within 2 years of screening Mild to moderate ulcerative colitis at the time of screening (2 < Mayo score < 12) 1 ≤ Endoscopy subscore ≤ 2, or fecal calprotectin > 150 mcg/g within 2 weeks of screening Patients on 5-aminosalicylates (e.g. mesalamine, etc.) must be on a stable dose for ≥ 4 weeks prior to screening Patients on treatment with immunosuppressive (azathioprine/6-mercaptopurine and methotrexate) or biologic medications (infliximab, adalimumab, and golimumab) must be on stable dose for 8 weeks prior to baseline At the time of baseline, patients may be on no more than 20 mg of prednisone and 9 mg of budesonide MMX Exclusion Criteria: Patients with Crohn's disease or indeterminate colitis History of colectomy Presence of ileal pouch or ostomy History of colonic dysplasia Evidence of active bacterial or viral gastroenteritis as indicated by positive stool studies for ova & parasites, clostridium difficile, and stool culture Severe to fulminant colitis Recent hospitalizations (within 2 weeks of screening) for ulcerative colitis requiring IV steroids Recent systemic antibiotics use (within 2 weeks of screening) Presence of the following labs indicative of severe colitis: a. Hemoglobin < 8.0 g/dl b. Albumin < 3.0 g/dl Use of Total Parenteral Nutrition (TPN) Active use of anti-diarrheal medications Use of cyclosporine, tacrolimus, or thalidomide within 2 months prior to screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Specific Carbohydrate Diet<br>Exclusive consumption of the specific carbohydrate diet for 6 weeks | Other: Specific Carbohydrate Diet<br>* Diet restricts all but simple carbohydrates and allows for inclusion of fresh fruits, vegetables, unprocessed meats, and homemade lactose-free cheese and yogurt.<br>|
| Experimental: Mediterranean Diet<br>Exclusive consumption of the Mediterranean diet for 6 weeks | Other: Mediterranean Diet<br>* Diet rich in whole vegetables, fruit, plant-based protein, and olive oil, with moderate amounts of seafood and dairy, and limited in sugar-sweetened goods, red meat, and nutrients like heme and sodium.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial Mayo Clinic Score | The partial Mayo clinic score measures disease activity, on a scale of 0 to 9. The higher scores indicate more severe disease activity (the worse outcome). | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial Mayo Clinic Score | The partial Mayo clinic score measures disease activity, on a scale of 0 to 9. The higher scores indicate more severe disease activity (the worse outcome). | Week 1, Week 2, Week 4, Week 10 follow-up | 
| Inflammatory Bowel Disease Questionnaire (IBDQ10) | The IBDQ10 measures quality of life, on a scale of 10 to 70. The higher scores indicate a better outcome (better quality of life). | Week 1, Week 2, Week 4, Week 6, and Week 10 follow-up | 
| Short Form (12) Health Survey (SF-12) | The SF-12 measures health-related quality of life, split into physical and mental health scores on a scale of 0 to 100. The higher scores indicate a better outcome. | Week 1, Week 2, Week 4, Week 6, and Week 10 follow-up | 
| Simple Clinical Colitis Activity Index (SCCAI) | The SCCAI measures disease activity, on a scale of 0 to 21. The higher scores indicate a worse outcome (more severe disease activity). | Week 1, Week 2, Week 4, Week 6, and Week 10 follow-up | 
| stool microbiome | Stool samples will be taken at screening/baseline and week 6 and 10 to assess change in fecal microbiome pattern, measured using R2Aspread plating, QiagenAllPrep RNA/DNA Mini kit, and whole genome shotgun sequencing. | Week 6 and Week 10 follow-up | 
| fecal calprotectin | Stool samples will be taken at screening/baseline and week 6 and 10 to assess change in fecal calprotectin levels. | Week 6 and Week 10 follow-up | 
| C-reactive protein | Blood will be drawn at baseline and week 6 to assess change in C-reactive protein levels. | Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet