SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis

NCT04398550 | Unknown DMC

• 1 other identifier: 2020P000298
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Keywords

Diet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Partial Mayo Clinic Score

  Week 1, Week 2, Week 4, Week 10 follow-up

• Inflammatory Bowel Disease Questionnaire (IBDQ10)

  Week 1, Week 2, Week 4, Week 6, and Week 10 follow-up

• Short Form (12) Health Survey (SF-12)

  Week 1, Week 2, Week 4, Week 6, and Week 10 follow-up

• Simple Clinical Colitis Activity Index (SCCAI)

  Week 1, Week 2, Week 4, Week 6, and Week 10 follow-up

• stool microbiome

  Week 6 and Week 10 follow-up

Study Arms (2)

Specific Carbohydrate Diet

EXPERIMENTAL

Exclusive consumption of the specific carbohydrate diet for 6 weeks

Other: Specific Carbohydrate Diet

Mediterranean Diet

EXPERIMENTAL

Exclusive consumption of the Mediterranean diet for 6 weeks

Other: Mediterranean Diet

Interventions

Specific Carbohydrate Diet OTHER

Diet restricts all but simple carbohydrates and allows for inclusion of fresh fruits, vegetables, unprocessed meats, and homemade lactose-free cheese and yogurt.

Specific Carbohydrate Diet

Mediterranean Diet OTHER

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.

Mediterranean Diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• ≤ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (25)

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MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Hamed Khalili, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hamed Khalili, MD, MPH

CONTACT

978-882-6709; hkhalili@partners.org

Katherine Williams

CONTACT

617-643-9374; kwilliams81@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine at Harvard Medical School

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: May 21, 2020
• Study Start: September 3, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)