Autoimmune Protocol Diet and Inflammatory Bowel Disease
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|ClinicalTrials.gov Identifier: NCT03512327|
Recruitment Status : Completed
First Posted : April 30, 2018
Last Update Posted : April 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Crohn Disease Ulcerative Colitis Inflammatory Bowel Diseases||Other: Autoimmune protocol (AIP) diet||Not Applicable|
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).
- To evaluate the effect of the AIP diet on clinical and endoscopic disease activity for CD and UC,
- To examine changes in inflammatory biomarkers during AIP diet
- To characterize changes in RNA expression from intestinal mucosal biopsy specimens from prior to diet initiation to end of the study.
- To characterize changes in fecal microbiome during diet intervention
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of the Autoimmune Protocol Diet for Inflammatory Bowel Disease|
|Actual Study Start Date :||September 1, 2016|
|Actual Primary Completion Date :||December 10, 2016|
|Actual Study Completion Date :||December 10, 2016|
Experimental: Autoimmune protocol (AIP) diet
Adult patients with active Crohn's disease or ulcerative colitis, undergoing 11 week autoimmune protocol diet, to examine therapeutic efficacy
Other: Autoimmune protocol (AIP) diet
Autoimmune protocol diet, designed as a 6 week step wise elimination phase followed by 5 week maintenance phase.
- Clinical remission for Crohn's disease [ Time Frame: 11 weeks ]Clinical disease activity scores will be measured by Harvey Bradshaw Index (0-16+) 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. Lower values represent better outcome. Clinical remission is defined as Harvey Bradshaw Index <5 for CD.
- Clinical remission for ulcerative colitis [ Time Frame: 11 weeks ]Clinical disease activity scores will be measured by Mayo score (range 0-12) for patients with ulcerative colitis (UC). The Mayo score includes measures of stool frequency, rectal bleeding, physician global assessment, and endoscopic assessment. Lower values represent better outcome. Clinical remission is defined as Mayo score 2 or less for UC.
- Mucosal healing [ Time Frame: 11 weeks ]Absence of erosions or ulcers on endoscopy or imaging
- Changes in inflammatory biomarkers, including c-reactive protein (CRP), during dietary intervention [ Time Frame: 11 weeks ]Compare pre-diet to post-diet values of CRP
- Changes in inflammatory biomarkers, including fecal calprotectin (FC), during dietary intervention [ Time Frame: 11 weeks ]Compare pre-diet to post-diet values of FC
- Changes in RNA expression from colonic mucosa [ Time Frame: 11 weeks ]RNA-seq performed on colonic biopsies from patients with UC pre- and post-dietary intervention
- Changes in fecal microbiome composition during dietary intervention [ Time Frame: 11 weeks ]Assess changes in fecal microbiome composition at baseline and at weeks 2, 4, 6, and 11 using 16S ribosomal RNA sequencing
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03512327
|Principal Investigator:||Gauree G Konijeti, MD, MPH||Gastroenterologist, Clinical Investigator|