Clinical Trials Directory

Trials / Completed

CompletedNCT03512327

Autoimmune Protocol Diet and Inflammatory Bowel Disease

Efficacy of the Autoimmune Protocol Diet for Inflammatory Bowel Disease

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
15 (actual)
Sponsor
Scripps Health · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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).

Detailed description

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

Conditions

Interventions

TypeNameDescription
OTHERAutoimmune protocol (AIP) dietAutoimmune protocol diet, designed as a 6 week step wise elimination phase followed by 5 week maintenance phase.

Timeline

Start date
2016-09-01
Primary completion
2016-12-10
Completion
2016-12-10
First posted
2018-04-30
Last updated
2025-01-09
Results posted
2025-01-09

Source: ClinicalTrials.gov record NCT03512327. Inclusion in this directory is not an endorsement.