Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease: A Series of N-of-1 Diet Trials

Heather C Kaplan^{1

2

3}, Lisa Opipari-Arrigan^{2

3

4}, Jiabei Yang⁵, Christopher H Schmid⁵, Christine L Schuler^{3

6}, Shehzad A Saeed⁷, Kimberly L Braly⁸, Fandi Chang⁵, Lauren Murphy², Cassandra M Dodds², Mason Nuding⁹, Hao Liu¹⁰, Sheri Pilley^{11

12}, Julie Stone^{11

13}, Gisele Woodward^{11

14}, Nancy Yokois¹⁵, Alka Goyal^{16

17}, Dale Lee⁸, Ann Ming Yeh¹⁷, Peter Lee¹⁸, Benjamin D Gold¹⁴, Zarela Molle-Rios¹⁹, R Jeff Zwiener²⁰, Sabina Ali²¹, Mallory Chavannes^{22

23}, Tiffany Linville²⁴, Ashish Patel^{25

26}, Travis Ayers²⁷, Mikelle Bassett²⁸, Brendan Boyle²⁹, Pablo Palomo³⁰, Sofia Verstraete³¹, Jill Dorsey³², Jess L Kaplan³³, Steven J Steiner³⁴, Kaylie Nguyen³⁵, Jennifer Burgis³¹, David L Suskind⁸; ImproveCareNow Pediatric IBD Learning Health System

Affiliations

¹ Perinatal Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
² James M. Anderson Center for Health Systems Excellence, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
³ Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.
⁴ Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
⁵ Department of Biostatistics and Center for Evidence Synthesis in Health, School of Public Health, Brown University, Providence, Rhode Island, USA.
⁶ Division of Hospital Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
⁷ Department of Medical Affairs, Dayton Children's Hospital and Boonshoft School of Medicine, Wright State University, Dayton, Ohio, USA.
⁸ Division of Gastroenterology and Hepatology, Seattle Children's Hospital, Seattle, Washington, USA.
⁹ Center for Clinical and Translational Research, Seattle Children's Research Institute, Division of Gastroenterology, Seattle Children's Hospital, Seattle, Washington, USA.
¹⁰ Division of Applied Mathematics, Brown University, Providence, Rhode Island, USA.
¹¹ Parent Working Group, ImproveCareNow Pediatric IBD Learning Health System.
¹² MUSC Health Shawn Jenkins Children's Hospital, Charleston, South Carolina, USA.
¹³ The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
¹⁴ Division of Gastroenterology, GI Care for Kids, Children's Healthcare of Atlanta, Atlanta, Georgia, USA.
¹⁵ Childrens Hospital of the King's Daughters, Division of Pediatric Gastroenterology, Norfolk, Virginia, USA.
¹⁶ Division of Gastroenterology, Hepatology, and Nutrition, Children's Mercy Hospital, Kansas City, Missouri, USA.
¹⁷ Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Stanford University, Palo Alto, California, USA.
¹⁸ Division of Pediatric Gastroenterology, Pediatric Specialists of Virginia, Fairfax, Virginia, USA.
¹⁹ Division of Pediatric Gastroenterology, Nemours Alfred I. duPont Hospital for Children, Wilmington, Delaware, USA.
²⁰ Dell Children's Medical Group, Pediatric Gastroenterology, Dell Children's Medical Center of Central Texas, Austin, Texas, USA.
²¹ Division of Pediatric Gastroenterology, Hepatology, and Nutrition, UCSF Benioff Children's Hospital, Oakland, California, USA.
²² Division of Gastroenterology, Hepatology, and Nutrition, Children's Hospital Los Angeles, Los Angeles, California, USA.
²³ Department of Pediatrics, University of Southern California, Los Angeles, California, USA.
²⁴ Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Levine Children's Hospital, Charlotte, North Carolina, USA.
²⁵ Department of Pediatrics, UT Southwestern Medical Center, Dallas, Texas, USA.
²⁶ Pediatric Gastroenterology, Phoenix Children's Hospital, Phoenix, Arizona, USA.
²⁷ Division of Pediatric Gastroenterology, Arkansas Children's Hospital, UAMS, Little Rock, Arkansas, USA.
²⁸ Division of Pediatric Gastroenterology, Oregon Health Sciences University, Portland, Oregon, USA.
²⁹ Division of Gastroenterology, Hepatology, and Nutrition, Nationwide Children's Hospital, Columbus, Ohio, USA.
³⁰ Division of Pediatric Gastroenterology, Nemours Children's Hospital, Orlando, Florida, USA.
³¹ Division of Pediatric Gastroenterology, UCSF Medical Center, San Francisco, California, USA.
³² Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Nemours Children's Specialty Care, Jacksonville, Florida, USA.
³³ Division of Pediatric Gastroenterology, MassGeneral Hospital for Children and Harvard Medical School, Boston, Massachusetts, USA.
³⁴ Division of Pediatric Gastroenterology/Hepatology/Nutrition, Riley Hospital for Children, Indiana University School of Medicine, Indianapolis, Indiana, USA.
³⁵ Division of Pediatric Gastroenterology, Hepatology and Nutrition, Lucile Packard Children's Hospital at Stanford, Stanford, California, USA.

PMID: 35442220
DOI: 10.14309/ajg.0000000000001800

Randomized Controlled Trial

Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease: A Series of N-of-1 Diet Trials

Heather C Kaplan et al. Am J Gastroenterol. 2022.

. 2022 Jun 1;117(6):902-917.

doi: 10.14309/ajg.0000000000001800. Epub 2022 Apr 20.

Authors

Affiliations

¹ Perinatal Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
² James M. Anderson Center for Health Systems Excellence, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
³ Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.
⁴ Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
⁵ Department of Biostatistics and Center for Evidence Synthesis in Health, School of Public Health, Brown University, Providence, Rhode Island, USA.
⁶ Division of Hospital Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
⁷ Department of Medical Affairs, Dayton Children's Hospital and Boonshoft School of Medicine, Wright State University, Dayton, Ohio, USA.
⁸ Division of Gastroenterology and Hepatology, Seattle Children's Hospital, Seattle, Washington, USA.
⁹ Center for Clinical and Translational Research, Seattle Children's Research Institute, Division of Gastroenterology, Seattle Children's Hospital, Seattle, Washington, USA.
¹⁰ Division of Applied Mathematics, Brown University, Providence, Rhode Island, USA.
¹¹ Parent Working Group, ImproveCareNow Pediatric IBD Learning Health System.
¹² MUSC Health Shawn Jenkins Children's Hospital, Charleston, South Carolina, USA.
¹³ The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
¹⁴ Division of Gastroenterology, GI Care for Kids, Children's Healthcare of Atlanta, Atlanta, Georgia, USA.
¹⁵ Childrens Hospital of the King's Daughters, Division of Pediatric Gastroenterology, Norfolk, Virginia, USA.
¹⁶ Division of Gastroenterology, Hepatology, and Nutrition, Children's Mercy Hospital, Kansas City, Missouri, USA.
¹⁷ Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Stanford University, Palo Alto, California, USA.
¹⁸ Division of Pediatric Gastroenterology, Pediatric Specialists of Virginia, Fairfax, Virginia, USA.
¹⁹ Division of Pediatric Gastroenterology, Nemours Alfred I. duPont Hospital for Children, Wilmington, Delaware, USA.
²⁰ Dell Children's Medical Group, Pediatric Gastroenterology, Dell Children's Medical Center of Central Texas, Austin, Texas, USA.
²¹ Division of Pediatric Gastroenterology, Hepatology, and Nutrition, UCSF Benioff Children's Hospital, Oakland, California, USA.
²² Division of Gastroenterology, Hepatology, and Nutrition, Children's Hospital Los Angeles, Los Angeles, California, USA.
²³ Department of Pediatrics, University of Southern California, Los Angeles, California, USA.
²⁴ Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Levine Children's Hospital, Charlotte, North Carolina, USA.
²⁵ Department of Pediatrics, UT Southwestern Medical Center, Dallas, Texas, USA.
²⁶ Pediatric Gastroenterology, Phoenix Children's Hospital, Phoenix, Arizona, USA.
²⁷ Division of Pediatric Gastroenterology, Arkansas Children's Hospital, UAMS, Little Rock, Arkansas, USA.
²⁸ Division of Pediatric Gastroenterology, Oregon Health Sciences University, Portland, Oregon, USA.
²⁹ Division of Gastroenterology, Hepatology, and Nutrition, Nationwide Children's Hospital, Columbus, Ohio, USA.
³⁰ Division of Pediatric Gastroenterology, Nemours Children's Hospital, Orlando, Florida, USA.
³¹ Division of Pediatric Gastroenterology, UCSF Medical Center, San Francisco, California, USA.
³² Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Nemours Children's Specialty Care, Jacksonville, Florida, USA.
³³ Division of Pediatric Gastroenterology, MassGeneral Hospital for Children and Harvard Medical School, Boston, Massachusetts, USA.
³⁴ Division of Pediatric Gastroenterology/Hepatology/Nutrition, Riley Hospital for Children, Indiana University School of Medicine, Indianapolis, Indiana, USA.
³⁵ Division of Pediatric Gastroenterology, Hepatology and Nutrition, Lucile Packard Children's Hospital at Stanford, Stanford, California, USA.

PMID: 35442220
DOI: 10.14309/ajg.0000000000001800

Abstract

Introduction: Evidence about specific carbohydrate diet (SCD) for inflammatory bowel disease (IBD) is limited. We conducted 54 single-subject, double-crossover N-of-1 trials comparing SCD with a modified SCD (MSCD) and comparing each with the participant's baseline, usual diet (UD).

Methods: Across 19 sites, we recruited patients aged 7-18 years with IBD and active inflammation. Following a 2-week baseline (UD), patients were randomized to 1 of 2 sequences of 4 alternating 8-week SCD and MSCD periods. Outcomes included fecal calprotectin and patient-reported symptoms. We report posterior probabilities from Bayesian models comparing diets.

Results: Twenty-one (39%) participants completed the trial, 9 (17%) completed a single crossover, and 24 (44%) withdrew. Withdrawal or early completion occurred commonly (lack of response [n = 11], adverse events [n = 11], and not desiring to continue [n = 6]). SCD and MSCD performed similarly for most individuals. On average, there was <1% probability of a clinically meaningful difference in IBD symptoms between SCD and MSCD. The average treatment difference was -0.3 (95% credible interval -1.2, 0.75). There was no significant difference in the ratio of fecal calprotectin geometric means comparing SCD and MSCD (0.77, 95% credible interval 0.51, 1.10). Some individuals had improvement in symptoms and fecal calprotectin compared with their UD, whereas others did not.

Discussion: SCD and MSCD did not consistently improve symptoms or inflammation, although some individuals may have benefited. However, there are inherent difficulties in examining dietary changes that complicate study design and ultimately conclusions regarding effectiveness.

Trial registration: ClinicalTrials.gov NCT03301311.

PubMed Disclaimer

References

1. Zenlea T, Peppercorn MA. Immunosuppressive therapies for inflammatory bowel disease. World J Gastroenterol 2014;20:3146–52.
1. Wong AP, Clark AL, Garnett EA, et al. Use of complementary medicine in pediatric patients with inflammatory bowel disease: Results from a multicenter survey. J Pediatr Gastroenterol Nutr 2009;48:55–60.
1. de Vries JHM, Dijkhuizen M, Tap P, et al. Patient's dietary beliefs and behaviours in inflammatory bowel disease. Dig Dis 2019;37:131–9.
1. Suskind DL, Wahbeh G, Cohen SA, et al. Patients perceive clinical benefit with the specific carbohydrate diet for inflammatory bowel disease. Dig Dis Sci 2016;61:3255–60.
1. van Rheenen PF, Aloi M, Assa A, et al. The medical management of paediatric Crohn's disease: An ECCO-ESPGHAN guideline update. J Crohns Colitis 2021;15(2):171–194.

Publication types

Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Substances

Actions

Associated data

Actions
- Search in PubMed
- Search in ClinicalTrials.gov

LinkOut - more resources

Full Text Sources
- Ovid Technologies, Inc.
- Wolters Kluwer
Medical
- ClinicalTrials.gov
- MedlinePlus Health Information

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease: A Series of N-of-1 Diet Trials

Affiliations

Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease: A Series of N-of-1 Diet Trials

Authors

Affiliations

Abstract

References

Publication types

MeSH terms

Substances

Associated data

LinkOut - more resources

Full Text Sources

Medical