There is limited data to guide the use of dietary change in the management of IBD, and it can prove challenging to implement in the setting of altered anatomy, comorbid conditions, and patient compliance. Therefore there is an important need to study diet as a therapy for IBD. Here, the investigators propose a novel study to evaluate the feasibility and efficacy of the autoimmune protocol (AIP) diet in patients with active Crohn's disease (CD) and ulcerative colitis (UC).
The investigators propose a novel study to evaluate the feasibility and efficacy of the autoimmune paleo (AIP) diet in patients with Crohn's disease (CD) and ulcerative colitis (UC). Specific aims: 1. To evaluate the effect of the AIP diet on clinical and endoscopic disease activity for CD and UC, 2. To examine changes in inflammatory biomarkers during AIP diet 3. To characterize changes in RNA expression from intestinal mucosal biopsy specimens from prior to diet initiation to end of the study. 4. To characterize changes in fecal microbiome during diet intervention
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Autoimmune protocol diet, designed as a 6 week step wise elimination phase followed by 5 week maintenance phase.
Number of Participants With Clinical Remission for Crohn's Disease
Clinical disease activity scores will be measured by Harvey Bradshaw Index for patients with Crohn's Disease (CD). The Harvey Bradshaw Index measures general well being, abdominal pain severity, number of stools daily, presence of abdominal mass, and complications. The Harvey Bradshaw Index ranges from 0-16, with lower values representing better outcome and higher values representing more disease activity. Clinical remission is defined as Harvey Bradshaw Index \<5 for CD.
Time frame: 11 weeks
Number of Participants With Clinical Remission for Ulcerative Colitis
Clinical disease activity scores will be measured by Mayo score for patients with ulcerative colitis (UC). The Mayo score includes measures of stool frequency, rectal bleeding, physician global assessment, and endoscopic assessment. The Mayo score ranges from 0-12, with lower values representing better outcome and higher values representing more disease activity. Clinical remission is defined as Mayo score 2 or less for UC.
Time frame: 11 weeks
Number of Participants With Mucosal Healing for Crohn's Disease or Ulcerative Colitis
Number of participants with Crohn's disease or ulcerative colitis who have absence of erosions or ulcers on endoscopy or imaging
Time frame: 11 weeks
Changes in Inflammatory Biomarkers, Including C-reactive Protein (CRP), During Dietary Intervention
Number of Participants with a change in C-reactive Protein Levels (inflammatory biomarker) from baseline to 11 weeks.
Time frame: 11 weeks
Changes in Inflammatory Biomarkers, Including Fecal Calprotectin (FC), During Dietary Intervention
Number of Participants with a change in fecal calprotectin levels (inflammatory biomarker) from baseline to 11 weeks.
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Time frame: 11 weeks
Major Biological Processes Gene Ontology Terms Enriched in Downregulated and Upregulated Genes
Description of changes in RNA expression from colonic biopsies from patients with ulcerative colitis from baseline to end of study (11 weeks). Specifically, examined top 10 major Biological Processes Gene Ontology Terms Enriched in Downregulated and Upregulated Genes
Time frame: 11 weeks
Changes in Fecal Microbiome Composition During Dietary Intervention
Changes in fecal microbiome composition at baseline and at weeks 2, 4, 6, and 11 using 16S ribosomal RNA sequencing
Time frame: 11 weeks