Evidence map›Paper›PMID 34052278›Full record

Trial reportGastroenterology2021

A Randomized Trial Comparing the Specific Carbohydrate Diet to a Mediterranean Diet in Adults With Crohn's Disease.

James D Lewis, Robert S Sandler, Carol Brotherton, Colleen Brensinger, Hongzhe Li, Michael D Kappelman, Scott G Daniel, Kyle Bittinger, Lindsey Albenberg, John F Valentine and 22 more

Erratum issued Registry-linked trialOpen access · greenAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Gastroenterology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03058679 (Open Label, Randomized, Multicenter, Comparative Effectiveness Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission in Patients With Crohn's Disease), which is not on this map. Cited by 167 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
167citing papers in PubMed, 11 pooled it
32.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03058679 nacompletednot on this map

Open Label, Randomized, Multicenter, Comparative Effectiveness Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission in Patients With Crohn's Disease

TypeinterventionalSponsorUniversity of PennsylvaniaRan2017 to 2020Enrolled197ConditionsCrohn DiseaseArmsDiet
3 · Its place in the literature

Who cites it

167 citing papers in PubMed, 11 syntheses or guidelines pooled it, 275 citations in OpenAlex.

  1. Mediterranean diet in treatment of inflammatory bowel disease: A systematic review and meta-analysis.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2026
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  19. Plant and Animal Protein Sources in Inflammatory Bowel Disease: Current Evidence and Clinical Implications.JGH open : an open access journal of gastroenterology and hepatology · 2026
    Review
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107 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

32 authors at 12 institutions in 1 country.

James D LewisDivision 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.
Robert S SandlerCrohn's & Colitis Foundation Clinical Research Alliance, New York, New York; Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, North Carolina.
Carol BrothertonStoolschool.org, Fairfax, Virginia.
Colleen BrensingerCenter for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania.
Hongzhe LiDepartment 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.
Michael D KappelmanDivision of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, North Carolina.
Scott G DanielDivision of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
Kyle BittingerDivision of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
Lindsey AlbenbergDivision of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
John F ValentineCrohn's & Colitis Foundation Clinical Research Alliance, New York, New York; Division of Gastroenterology, Hepatology and Nutrition, University of Utah Health, Salt Lake City, Utah.
John S HansonCrohn's & Colitis Foundation Clinical Research Alliance, New York, New York; Atrium Health Gastroenterology and Hepatology, Charlotte, North Carolina.
David L SuskindSeattle Children's Hospital, Seattle, Washington; University of Washington, Seattle, Washington.
Andrea MeyerThe Great Bowel Movement, Chicago, Illinois.
Charlene W CompherDepartment of Biobehavioral Health Science, School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania.
Meenakshi BewtraDivision 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.
Akriti SaxenaDivision of Gastroenterology and Hepatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Crohn's & Colitis Foundation Clinical Research Alliance, New York, New York.
Angela DobesCrohn's & Colitis Foundation, New York, New York.
Benjamin L CohenCrohn'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.
Ann D FlynnCrohn's & Colitis Foundation Clinical Research Alliance, New York, New York; Division of Gastroenterology, Hepatology and Nutrition, University of Utah Health, Salt Lake City, Utah.
Monika FischerCrohn's & Colitis Foundation Clinical Research Alliance, New York, New York; Division of Gastroenterology and Hepatology, Indiana University, Indianapolis, Indiana.
Sumona SahaCrohn'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.
Arun SwaminathCrohn'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.
Bruce YacyshynCrohn's & Colitis Foundation Clinical Research Alliance, New York, New York; University of Cincinnati, Cincinnati, Ohio.
Ellen ScherlCrohn'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.
Sara HorstCrohn's & Colitis Foundation Clinical Research Alliance, New York, New York; Division of Gastroenterology and Hepatology, Vanderbilt University Medical Center, Nashville, Tennessee.
Jeffrey R CurtisDivision of Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama.
Kimberly BralyCenter for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania.
Lisa NesselCenter for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania.
Maureen McCauleyCenter for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania.
Liam McKeeverCenter for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania.
Hans HerfarthCrohn's & Colitis Foundation Clinical Research Alliance, New York, New York; Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, North Carolina.
DINE-CD Study Group
Crohn's and Colitis Foundation · USUniversity of Pennsylvania · USChildren's Hospital of Philadelphia · USUniversity of North Carolina at Chapel Hill · USUniversity of Utah · USAtrium Medical Cente · USCleveland Clinic · USLenox Hill Hospital · USNewYork–Presbyterian Hospital · USSeattle Children's Hospital · USUniversity of Alabama at Birmingham · USUniversity of Wisconsin–Madison · US

Funding

Phenotypic Diversity in COVID-19UL1TR001878 · NCATS · UNIVERSITY OF PENNSYLVANIA · PI FITZGERALD, GARRET A · 2016 to 2025
$102.4M
TRANSGENIC AND CHIMERIC MOUSE COREP30DK050306 · NIDDK · UNIVERSITY OF PENNSYLVANIA · PI REBECCA G WELLS · 1997 to 2026
$32.5M
UNIV OF NORTH CAROLINA CLINICAL NUTRITION RESEARCH UNITP30DK056350 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Ian Michael Carroll · 1999 to 2026
$31.6M
PILOT AND FEASIBILITY STUDIESP30DK034987 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Temitope O. Keku · 1985 to 2026
$30.5M
NCATS NIH HHS UL1 TR001878NIDDK NIH HHS P30 DK034987NIDDK NIH HHS P30 DK050306NIDDK NIH HHS P30 DK056350
6 · The paper itself

Abstract

BACKGROUND &

aimsThis 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.

methodsAdult 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).

resultsThe 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).

conclusionsThe 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.

Indexed as

Diet, MediterraneanAdultBiomarkersComparative Effectiveness ResearchC-Reactive ProteinCrohn DiseaseDietary CarbohydratesFecesFemaleGastrointestinal MicrobiomeHumansInflammation MediatorsLeukocyte L1 Antigen ComplexMaleMiddle AgedRemission InductionBiomarkersC-Reactive ProteinDietary CarbohydratesInflammation MediatorsLeukocyte L1 Antigen ComplexClinical TrialComparative EffectivenessMediterranean DietNutritionRandomization

Identifiers

PMID34052278
PMCPMC8396394
OpenAlexW3165463838

What OpenQuestion holds

Textmetadata
LicenceTDM
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.