Project Summary  

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Crohn’s disease affects more than 500,000 Americans. People with Crohn’s disease have ongoing stomach pain, cramping, and diarrhea. These symptoms can reduce patients’ quality of life and require hospital stays or surgery.

Most people with Crohn’s disease need treatment with medicine. However, these medicines may not get rid of all symptoms and may have side effects. A person’s diet can affect symptoms, but doctors don’t know if some diets are better for people with Crohn’s disease than others.

This research study is comparing the effects of two diets on symptoms and bowel inflammation in patients with Crohn’s disease.

• The first is the specific carbohydrate diet, or SCD. This diet limits the types of carbohydrates a person can eat. The diet allows fruits, vegetables except potatoes and yams, unprocessed meats, and some lactose-free dairy. Grains such as wheat, rice, and oats aren’t allowed.
• The second diet is the Mediterranean-style diet, or MSD. This diet allows more fiber and less red meat than Americans usually eat. The MSD has many health benefits and may be easier for people to follow than the SCD.

Who can this research help?

Patients with Crohn’s disease and their doctors can use findings from the study to learn how certain diets affect their symptoms.

What is the research team doing?

The research team is enrolling 194 adults with Crohn’s disease. Patients must have access to a computer with internet. They must also be able to have food delivered to them for six weeks. The team assigns patients by chance to either the SCD or MSD. Patients get food delivered to their homes every Friday for six weeks. They get three prepared meals and two snacks for each day. Patients also get recipes for these meals and directions on how to follow the diet on their own after the deliveries end.

After six weeks, patients can either pay to keep getting the prepared meals or continue the diet on their own. Using patient-reported symptoms and results from blood and stool tests, the research team tracks patients’ diarrhea, stomach pain, well-being, and any swelling in the bowels at 6 and 12 weeks. The team also looks at how many patients continue the diets on their own after six weeks and, for patients who stop their diet, their reasons for stopping.

Patients, clinicians, and the Crohn’s & Colitis Foundation are helping to plan and conduct the study.

Research methods at a glance

Design Elements	Description
Design	Randomized controlled trial
Population	Adults aged 18 years and older with Crohn’s disease
Interventions/ Comparators	SCD MSD
Outcomes	Primary: recurrence of symptoms, bowel inflammation Secondary: clinical remission, systemic inflammation
Timeframe	6-month follow-up for primary outcomes

Project Details

Principal Investigator

James D. Lewis, MD, MS

Project Status

In progress; Enrollment complete

Project Title

Comparative Effectiveness of Specific Carbohydrate and Mediterranean Diets to Induce Remission in Patients With Crohn's Disease

Board Approval Date

March 2016

Project End Date

July 2021

Organization

Crohn's and Colitis Foundation of America, Inc.

Year Awarded

2016

State

New York

Project Type

Research Project

Health Conditions  

Gastrointestinal Disorders

Crohns Disease

Intervention Strategies

Behavioral Interventions
Complementary and Alternative Medicine

Funding Announcement

Patient-Powered Research Networks (PPRN) Research Demonstration Projects

Project Budget

$2,570,809

Study Registration Information

HSRP20163175

NCT03058679