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Specific Carbohydrate Diet vs. Mediterranean Diet for Ulcerative Colitis

N/A
Recruiting
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
History of active ulcerative colitis for at least 3 months before screening
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

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have had ulcerative colitis that was active for at least 3 months before the screening.

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

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

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
2,918 Previous Clinical Trials
13,192,918 Total Patients Enrolled
5 Trials studying Ulcerative Colitis
630 Patients Enrolled for Ulcerative 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
Ulcerative Colitis Research Study Groups: Specific Carbohydrate Diet, Mediterranean Diet
Ulcerative 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research study accommodating participants over the age of fifty-five?

"This trial has an age range from 18 to 75, according to the entry requirements."

Answered by AI

How many participants have enrolled in this research trial?

"Affirmative. According to clinicaltrials.gov, this study is actively recruiting candidates and was initially published on September 3rd 2020 with the most recent update coming on May 27th 2022. The trial hopes to onboard 50 participants for their research at a single site."

Answered by AI

Are there still opportunities to join this medical investigation?

"According to the clinicaltrials.gov registry, this medical trial is actively recruiting volunteers and has been since September 3rd 2020 (last updated May 27th 2022)."

Answered by AI

Who is eligible to participate in this trial?

"This clinical trial is looking for approximately 50 people who have been diagnosed with colitis, ulcerative and are between 18-75 years of age to qualify."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
How old are they?
18 - 65
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
~11 spots leftby Mar 2025