Crohn Disease Clinical Trial
Official title:
Randomized Trial of Diet for Crohn's Disease and Impact on Disease Activity and the Microbiome
Recent data suggest that diet in inflammatory bowel disease (IBD) may lead to both symptom control and disease remission. Historically certain diets have been recommended for patients with Crohn's disease during exacerbations despite lack of data supporting efficacy. The investigators propose to evaluate two such diets by randomizing 32 subjects with mildly to moderately active Crohn's disease to one of two diets that differ in the amount and type of carbohydrates and fiber. Subjects will remain on the diet for 8 weeks and will be evaluated for changes from baseline in inflammatory biomarkers, symptomatic disease activity, and the microbiome.
Status | Recruiting |
Enrollment | 32 |
Est. completion date | December 2019 |
Est. primary completion date | September 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Consentable adults of age 18 or older. - Diagnosis of Crohn's disease made by a primary gastroenterologist based upon history, physical exam, laboratory/radiological studies, and endoscopy with biopsy. - Fecal Calprotectin = 300 - Mild to moderate disease activity based upon a modified Harvey Bradshaw Index score of 5-16. - On stable medication doses for = 2 months. Exclusion Criteria: - Inability/unwillingness to adhere to dietary recommendations. - Allergy or intolerance to any major component of the diets. Major component defined as an ingredient which, when left out of intervention diets, may affect study outcomes. - Allium intolerance - Exclusively vegetarian diet - Active intra-abdominal or perianal abscess/fistula - Symptomatic bowel stricture - Other serious medical conditions such as neurological, liver, kidney, autoimmune, or systemic disease - Use of corticosteroids within 1 month prior to baseline visit - Tobacco, alcohol, or illicit drug abuse - Pregnant subjects - Celiac disease - Patients already on one of the diets being studied - C. difficile or other enteric infection (O&P, stool enterics) - Antibiotic use within 2 months prior to baseline visit |
Country | Name | City | State |
---|---|---|---|
United States | University of Washington Medical Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington |
United States,
David LA, Maurice CF, Carmody RN, Gootenberg DB, Button JE, Wolfe BE, Ling AV, Devlin AS, Varma Y, Fischbach MA, Biddinger SB, Dutton RJ, Turnbaugh PJ. Diet rapidly and reproducibly alters the human gut microbiome. Nature. 2014 Jan 23;505(7484):559-63. doi: 10.1038/nature12820. Epub 2013 Dec 11. — View Citation
Hou JK, Abraham B, El-Serag H. Dietary intake and risk of developing inflammatory bowel disease: a systematic review of the literature. Am J Gastroenterol. 2011 Apr;106(4):563-73. doi: 10.1038/ajg.2011.44. Review. — View Citation
Manichanh C, Borruel N, Casellas F, Guarner F. The gut microbiota in IBD. Nat Rev Gastroenterol Hepatol. 2012 Oct;9(10):599-608. doi: 10.1038/nrgastro.2012.152. Epub 2012 Aug 21. Review. — View Citation
Richman E, Rhodes JM. Review article: evidence-based dietary advice for patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2013 Nov;38(10):1156-71. doi: 10.1111/apt.12500. Epub 2013 Sep 17. Review. — View Citation
Wu GD, Chen J, Hoffmann C, Bittinger K, Chen YY, Keilbaugh SA, Bewtra M, Knights D, Walters WA, Knight R, Sinha R, Gilroy E, Gupta K, Baldassano R, Nessel L, Li H, Bushman FD, Lewis JD. Linking long-term dietary patterns with gut microbial enterotypes. Science. 2011 Oct 7;334(6052):105-8. doi: 10.1126/science.1208344. Epub 2011 Sep 1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fecal Calprotectin Remission | To compare the proportion of patients with calprotectin remission (fecal calprotectin level < 250 and a decrease by = 100 points) at 8 weeks post-dietary intervention for subjects on each diet | 8 weeks | |
Secondary | Fecal Calprotectin Response | Calprotectin response (decrease by = 100 points) or calprotectin improvement (decrease by > 50%) at weeks 4 and 8 for subjects on each diet. Comparison of the mean calprotectin between the 2 treatment groups. | 8 weeks | |
Secondary | Clinical Response | Proportion of patients on each diet with clinical response (HBI score decrease by = 3) or remission (HBI score < 5) at weeks 4 and 8 | 8 weeks | |
Secondary | Metagenomics | To compare changes in the metagenomics of the fecal microbiome at 8 weeks relative to baseline for each diet | 8 weeks | |
Secondary | Microbiota correlation with clinical disease activity and inflammatory biomarkers | To determine if changes in the microbiota are associated with changes in clinical disease activity (HBI score), or inflammatory biomarkers (fecal calprotectin, C-reactive protein, etc.). | 8 weeks | |
Secondary | Future Use | To collect stool and blood for potential future analysis looking at proteomics and metabolomics. | 8 weeks |
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