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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
Sponsor:
Information provided by (Responsible Party):
Hamed Khalili, Massachusetts General Hospital

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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.

  4. 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).

  5. 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.

  6. 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.

  7. C-reactive protein [ Time Frame: Week 6 ]
    Blood will be drawn at baseline and week 6 to assess change in C-reactive protein levels.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Hamed Khalili, MD, MPH 978-882-6709 hkhalili@partners.org
Contact: Lauren Canha 617-724-1688 lcanha@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Lauren Canha    617-724-1688    lcanha@mgh.harvard.edu   
Contact: Jessica McGoldrick       jmcgoldrick2@mgh.harvard.edu   
Principal Investigator: Hamed Khalili, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Hamed Khalili, MD, MPH Massachusetts General Hospital
Publications:

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Responsible Party: Hamed Khalili, Assistant Professor of Medicine at Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04398550    
Other Study ID Numbers: 2020P000298
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: May 17, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only de-identified information may be shared with other collaborators and entities involved in generating data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hamed Khalili, Massachusetts General Hospital:
Diet
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases