SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis

May 27, 2022 updated by: Hamed Khalili, Massachusetts General Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Week 1, Week 2, Week 4, Week 10 follow-up
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).
Week 1, Week 2, Week 4, Week 6, and Week 10 follow-up
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.
Week 1, Week 2, Week 4, Week 6, and Week 10 follow-up
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).
Week 1, Week 2, Week 4, Week 6, and Week 10 follow-up
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.
Week 6 and Week 10 follow-up
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.
Week 6 and Week 10 follow-up
C-reactive protein
Time Frame: Week 6
Blood will be drawn at baseline and week 6 to assess change in C-reactive protein levels.
Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Hamed Khalili, MD, MPH, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2020

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

February 24, 2020

First Submitted That Met QC Criteria

May 18, 2020

First Posted (Actual)

May 21, 2020

Study Record Updates

Last Update Posted (Actual)

May 31, 2022

Last Update Submitted That Met QC Criteria

May 27, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020P000298

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Only de-identified information may be shared with other collaborators and entities involved in generating data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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