SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis
Primary Purpose
Ulcerative Colitis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Specific Carbohydrate Diet
Mediterranean Diet
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Diet
Eligibility 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
Sites / Locations
- Massachusetts General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Specific Carbohydrate Diet
Mediterranean Diet
Arm Description
Exclusive consumption of the specific carbohydrate diet for 6 weeks
Exclusive consumption of the Mediterranean diet for 6 weeks
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
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.
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).
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.
fecal calprotectin
Stool samples will be taken at screening/baseline and week 6 and 10 to assess change in fecal calprotectin levels.
C-reactive protein
Blood will be drawn at baseline and week 6 to assess change in C-reactive protein levels.
Full Information
NCT ID
NCT04398550
First Posted
February 24, 2020
Last Updated
May 27, 2022
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04398550
Brief Title
SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis
Official Title
Specific Carbohydrate Diet vs. Mediterranean Diet Therapy in Ulcerative Colitis - A Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 3, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Diet
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Specific Carbohydrate Diet
Arm Type
Experimental
Arm Description
Exclusive consumption of the specific carbohydrate diet for 6 weeks
Arm Title
Mediterranean Diet
Arm Type
Experimental
Arm Description
Exclusive consumption of the Mediterranean diet for 6 weeks
Intervention Type
Other
Intervention Name(s)
Specific Carbohydrate Diet
Intervention Description
Diet restricts all but simple carbohydrates and allows for inclusion of fresh fruits, vegetables, unprocessed meats, and homemade lactose-free cheese and yogurt.
Intervention Type
Other
Intervention Name(s)
Mediterranean Diet
Intervention Description
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 Measure Information:
Title
Partial Mayo Clinic Score
Description
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).
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Partial Mayo Clinic Score
Description
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).
Time Frame
Week 1, Week 2, Week 4, Week 10 follow-up
Title
Inflammatory Bowel Disease Questionnaire (IBDQ10)
Description
The IBDQ10 measures quality of life, on a scale of 10 to 70. The higher scores indicate a better outcome (better quality of life).
Time Frame
Week 1, Week 2, Week 4, Week 6, and Week 10 follow-up
Title
Short Form (12) Health Survey (SF-12)
Description
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.
Time Frame
Week 1, Week 2, Week 4, Week 6, and Week 10 follow-up
Title
Simple Clinical Colitis Activity Index (SCCAI)
Description
The SCCAI measures disease activity, on a scale of 0 to 21. The higher scores indicate a worse outcome (more severe disease activity).
Time Frame
Week 1, Week 2, Week 4, Week 6, and Week 10 follow-up
Title
stool microbiome
Description
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.
Time Frame
Week 6 and Week 10 follow-up
Title
fecal calprotectin
Description
Stool samples will be taken at screening/baseline and week 6 and 10 to assess change in fecal calprotectin levels.
Time Frame
Week 6 and Week 10 follow-up
Title
C-reactive protein
Description
Blood will be drawn at baseline and week 6 to assess change in C-reactive protein levels.
Time Frame
Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hamed Khalili, MD, MPH
Phone
978-882-6709
Email
hkhalili@partners.org
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine Williams
Phone
617-643-9374
Email
kwilliams81@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamed Khalili, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Williams
Phone
617-643-9374
Email
kwilliams81@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Jessica McGoldrick
Email
jmcgoldrick2@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Hamed Khalili, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Only de-identified information may be shared with other collaborators and entities involved in generating data.
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SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis
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