SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis
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|ClinicalTrials.gov Identifier: NCT04398550|
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : May 17, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Other: Specific Carbohydrate Diet Other: Mediterranean Diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||The investigators, subjects, and remaining study staff will not be intentionally unblinded. Due to the nature of the study, subjects, study staff, and investigators interacting with the subjects will likely be able to figure out what diet the subject is assigned to, however, the exact diet will not be explicitly revealed to them.|
|Official Title:||Specific Carbohydrate Diet vs. Mediterranean Diet Therapy in Ulcerative Colitis - A Clinical Trial|
|Actual Study Start Date :||September 3, 2020|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Specific Carbohydrate Diet
Exclusive consumption of the specific carbohydrate diet for 6 weeks
Other: Specific Carbohydrate Diet
Diet restricts all but simple carbohydrates and allows for inclusion of fresh fruits, vegetables, unprocessed meats, and homemade lactose-free cheese and yogurt.
Experimental: Mediterranean Diet
Exclusive consumption of the Mediterranean diet for 6 weeks
Other: Mediterranean Diet
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.
- Partial Mayo Clinic Score [ Time Frame: Week 6 ]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).
- Partial Mayo Clinic Score [ Time Frame: Week 1, Week 2, Week 4, Week 10 follow-up ]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).
- Inflammatory Bowel Disease Questionnaire (IBDQ10) [ Time Frame: Week 1, Week 2, Week 4, Week 6, and Week 10 follow-up ]The IBDQ10 measures quality of life, on a scale of 10 to 70. The higher scores indicate a better outcome (better quality of life).
- Short Form (12) Health Survey (SF-12) [ Time Frame: Week 1, Week 2, Week 4, Week 6, and Week 10 follow-up ]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.
- Simple Clinical Colitis Activity Index (SCCAI) [ Time Frame: Week 1, Week 2, Week 4, Week 6, and Week 10 follow-up ]The SCCAI measures disease activity, on a scale of 0 to 21. The higher scores indicate a worse outcome (more severe disease activity).
- stool microbiome [ Time Frame: Week 6 and Week 10 follow-up ]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.
- fecal calprotectin [ Time Frame: Week 6 and Week 10 follow-up ]Stool samples will be taken at screening/baseline and week 6 and 10 to assess change in fecal calprotectin levels.
- C-reactive protein [ Time Frame: Week 6 ]Blood will be drawn at baseline and week 6 to assess change in C-reactive protein levels.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04398550
|Contact: Hamed Khalili, MD, MPHfirstname.lastname@example.org|
|Contact: Lauren Canhaemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Lauren Canha 617-724-1688 firstname.lastname@example.org|
|Contact: Jessica McGoldrick email@example.com|
|Principal Investigator: Hamed Khalili, MD|
|Principal Investigator:||Hamed Khalili, MD, MPH||Massachusetts General Hospital|