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Specific Carbohydrate Diet vs. Mediterranean Diet for Ulcerative Colitis

N/A
Waitlist Available
Led By Hamed Khalili, MD, MPH
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1, week 2, week 4, week 6, and week 10 follow-up
Awards & highlights
No Placebo-Only Group

Summary

This trial is investigating whether the Specific Carbohydrate Diet or the Mediterranean diet can help improve ulcerative colitis symptoms.

Who is the study for?
This trial is for individuals with mild to moderate ulcerative colitis, who are on stable doses of certain medications like prednisone or mesalamine. They should not have severe colitis, recent hospitalizations for UC, a history of colectomy, or be using TPN. Participants must pick up meals from MGH and can't have Crohn's disease.
What is being tested?
The study compares the Specific Carbohydrate Diet (SCD) and the Mediterranean diet to see which one improves symptoms in ulcerative colitis patients. It involves 10 visits over 12 weeks at MGH where participants will receive prepared meals and undergo assessments including stool samples and blood tests.
What are the potential side effects?
Since this trial involves dietary interventions rather than medication, side effects may include changes in digestion such as discomfort or altered bowel habits as the body adjusts to new diets.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1, week 2, week 4, week 6, and week 10 follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1, week 2, week 4, week 6, and week 10 follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
C-reactive protein
Inflammatory Bowel Disease Questionnaire (IBDQ10)
Partial Mayo Clinic Score
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Specific Carbohydrate DietExperimental Treatment1 Intervention
Exclusive consumption of the specific carbohydrate diet for 6 weeks
Group II: Mediterranean DietExperimental Treatment1 Intervention
Exclusive consumption of the Mediterranean diet for 6 weeks

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,006 Previous Clinical Trials
13,307,232 Total Patients Enrolled
6 Trials studying Colitis
823 Patients Enrolled for Colitis
Hamed Khalili, MD, MPHPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital
University Of Texas Southwestern Medical Ctr At Dallas (Medical School)

Media Library

Mediterranean Diet Clinical Trial Eligibility Overview. Trial Name: NCT04398550 — N/A
Colitis Research Study Groups: Specific Carbohydrate Diet, Mediterranean Diet
Colitis Clinical Trial 2023: Mediterranean Diet Highlights & Side Effects. Trial Name: NCT04398550 — N/A
Mediterranean Diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT04398550 — N/A
~10 spots leftby Nov 2025
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