James D Lewis1, Robert S Sandler2, Carol Brotherton3, Colleen Brensinger4, Hongzhe Li5, Michael D Kappelman6, Scott G Daniel7, Kyle Bittinger7, Lindsey Albenberg7, John F Valentine8, John S Hanson9, David L Suskind10, Andrea Meyer11, Charlene W Compher12, Meenakshi Bewtra13, Akriti Saxena14, Angela Dobes15, Benjamin L Cohen16, Ann D Flynn8, Monika Fischer17, Sumona Saha18, Arun Swaminath19, Bruce Yacyshyn20, Ellen Scherl21, Sara Horst22, Jeffrey R Curtis23, Kimberly Braly4, Lisa Nessel4, Maureen McCauley4, Liam McKeever4, Hans Herfarth2. 1. Division of Gastroenterology and Hepatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania; Crohn's & Colitis Foundation Clinical Research Alliance, New York, New York. Electronic address: lewisjd@pennmedicine.upenn.edu. 2. Crohn's & Colitis Foundation Clinical Research Alliance, New York, New York; Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, North Carolina. 3. Stoolschool.org, Fairfax, Virginia. 4. Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania. 5. Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania. 6. Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, North Carolina. 7. Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania. 8. Crohn's & Colitis Foundation Clinical Research Alliance, New York, New York; Division of Gastroenterology, Hepatology and Nutrition, University of Utah Health, Salt Lake City, Utah. 9. Crohn's & Colitis Foundation Clinical Research Alliance, New York, New York; Atrium Health Gastroenterology and Hepatology, Charlotte, North Carolina. 10. Seattle Children's Hospital, Seattle, Washington; University of Washington, Seattle, Washington. 11. The Great Bowel Movement, Chicago, Illinois. 12. Department of Biobehavioral Health Science, School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania. 13. Division of Gastroenterology and Hepatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania; Crohn's & Colitis Foundation Clinical Research Alliance, New York, New York. 14. Division of Gastroenterology and Hepatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Crohn's & Colitis Foundation Clinical Research Alliance, New York, New York. 15. Crohn's & Colitis Foundation, New York, New York. 16. Crohn's & Colitis Foundation Clinical Research Alliance, New York, New York; Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York; Department of Gastroenterology, Hepatology, and Nutrition, Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, Ohio. 17. Crohn's & Colitis Foundation Clinical Research Alliance, New York, New York; Division of Gastroenterology and Hepatology, Indiana University, Indianapolis, Indiana. 18. Crohn's & Colitis Foundation Clinical Research Alliance, New York, New York; Division of Gastroenterology and Hepatology, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin. 19. Crohn's & Colitis Foundation Clinical Research Alliance, New York, New York; Division of Gastroenterology, Lenox Hill Hospital, Zucker School of Medicine at Hofstra/Northwell, New York, New York. 20. Crohn's & Colitis Foundation Clinical Research Alliance, New York, New York; University of Cincinnati, Cincinnati, Ohio. 21. Crohn's & Colitis Foundation Clinical Research Alliance, New York, New York; The Jill Roberts IBD Center, Weill Cornell Medicine, New York Presbyterian Hospital, New York, New York. 22. Crohn's & Colitis Foundation Clinical Research Alliance, New York, New York; Division of Gastroenterology and Hepatology, Vanderbilt University Medical Center, Nashville, Tennessee. 23. Division of Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama.
Abstract
BACKGROUND & AIMS: This study compared the effectiveness of the Specific Carbohydrate Diet (SCD) to the Mediterranean diet (MD) as treatment for Crohn's disease (CD) with mild to moderate symptoms. METHODS: Adult patients with CD and with mild-to-moderate symptoms were randomly assigned 1:1 to consume the MD or SCD for 12 weeks. For the first 6 weeks, participants received prepared meals and snacks according to their assigned diet. After 6 weeks, participants were instructed to follow the diet independently. The primary outcome was symptomatic remission at week 6. Key secondary outcomes at week 6 included fecal calprotectin (FC) response (FC <250 μg/g and reduction by >50% among those with baseline FC >250 μg/g) and C-reactive protein (CRP) response (high-sensitivity CRP <5 mg/L and >50% reduction from baseline among those with high-sensitivity CRP >5 mg/L). RESULTS: The study randomized 194 patients, and 191 were included in the efficacy analyses. The percentage of participants who achieved symptomatic remission at week 6 was not superior with the SCD (SCD, 46.5%; MD, 43.5%; P = .77). FC response was achieved in 8 of 23 participants (34.8%) with the SCD and in 4 of 13 participants (30.8%) with the MD (P = .83). CRP response was achieved in 2 of 37 participants (5.4%) with the SCD and in 1 of 28 participants (3.6%) with the MD (P = .68). CONCLUSIONS: The SCD was not superior to the MD to achieve symptomatic remission, FC response, and CRP response. CRP response was uncommon. Given these results, the greater ease of following the MD and other health benefits associated with the MD, the MD may be preferred to the SCD for most patients with CD with mild to moderate symptoms. ClinicalTrials.gov Identifier: NCT03058679.
BACKGROUND & AIMS: This study compared the effectiveness of the Specific Carbohydrate Diet (SCD) to the Mediterranean diet (MD) as treatment for Crohn's disease (CD) with mild to moderate symptoms. METHODS: Adult patients with CD and with mild-to-moderate symptoms were randomly assigned 1:1 to consume the MD or SCD for 12 weeks. For the first 6 weeks, participants received prepared meals and snacks according to their assigned diet. After 6 weeks, participants were instructed to follow the diet independently. The primary outcome was symptomatic remission at week 6. Key secondary outcomes at week 6 included fecal calprotectin (FC) response (FC <250 μg/g and reduction by >50% among those with baseline FC >250 μg/g) and C-reactive protein (CRP) response (high-sensitivity CRP <5 mg/L and >50% reduction from baseline among those with high-sensitivity CRP >5 mg/L). RESULTS: The study randomized 194 patients, and 191 were included in the efficacy analyses. The percentage of participants who achieved symptomatic remission at week 6 was not superior with the SCD (SCD, 46.5%; MD, 43.5%; P = .77). FC response was achieved in 8 of 23 participants (34.8%) with the SCD and in 4 of 13 participants (30.8%) with the MD (P = .83). CRP response was achieved in 2 of 37 participants (5.4%) with the SCD and in 1 of 28 participants (3.6%) with the MD (P = .68). CONCLUSIONS: The SCD was not superior to the MD to achieve symptomatic remission, FC response, and CRP response. CRP response was uncommon. Given these results, the greater ease of following the MD and other health benefits associated with the MD, the MD may be preferred to the SCD for most patients with CD with mild to moderate symptoms. ClinicalTrials.gov Identifier: NCT03058679.
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