SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04398550
• Other study ID #: 2020P000298
• Status: Recruiting
• Phase: N/A
• Start date: September 3, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2022
• Source: Massachusetts General Hospital
• Contact: Hamed Khalili, MD, MPH
• Phone: 978-882-6709
• Email: hkhalili[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	C-reactive protein	Blood will be drawn at baseline and week 6 to assess change in C-reactive protein levels.	Week 6