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  • Comparing Two Diets for Patients with...

Comparing Two Diets for Patients with Crohn’s Disease

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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

Related Articles

Clinical Gastroenterology and Hepatology

Variation Among Patients With Crohn's Disease in Benefit vs Risk Preferences and Remission Time Equivalents

Value In Health

Comparing the Noncomparable: The Need for Equivalence Measures That Make Sense in Health-Economic Evaluations

Project Details

Principal Investigator
James D. Lewis, MD, MS
Project Status
In progress; Data collected
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
Page Last Updated: 
September 28, 2020

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