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
| Type | Name | Description |
|---|---|---|
| OTHER | Autoimmune protocol (AIP) diet | Autoimmune 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.