N/A
N=15
Autoimmune Protocol Diet and Inflammatory Bowel Disease
Crohn Disease · Ulcerative Colitis · Inflammatory Bowel Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03512327 ↗Enrolled (actual)
15
Serious AEs
6.7%
Results posted
Jan 2025
Primary outcome: Primary: Number of Participants With Clinical Remission for Crohn's Disease — 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Autoimmune protocol (AIP) diet (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Scripps Health
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinical Remission for Crohn's Disease |
6 | — |
| PRIMARY Number of Participants With Clinical Remission for Ulcerative Colitis |
5 | — |
| SECONDARY Number of Participants With Mucosal Healing for Crohn's Disease or Ulcerative Colitis |
7 | — |
| SECONDARY Changes in Inflammatory Biomarkers, Including C-reactive Protein (CRP), During Dietary Intervention |
9 | — |
| SECONDARY Changes in Inflammatory Biomarkers, Including Fecal Calprotectin (FC), During Dietary Intervention |
6 | — |
| SECONDARY Major Biological Processes Gene Ontology Terms Enriched in Downregulated and Upregulated Genes |
10 | — |
| SECONDARY Changes in Fecal Microbiome Composition During Dietary Intervention |
— | — |
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).
Eligibility Criteria
Inclusion Criteria
- At least 18 years of age
- Able to provide written informed consent prior to screening and to comply with the requirements of the study protocol.
- Established diagnosis of small bowel CD or colonic CD or ulcerative colitis
- Confirmation of active CD or UC with recent (within 6 months of consent or prior to study start) objective evidence of endoscopically active disease on colonoscopy or computed tomography/magnetic resonance enterography or video capsule endoscopy
- Any medications being currently used for IBD must remain stable during the study period with the exception of tapering of corticosteroids.
- Current disease activity defined as a Harvey Bradshaw index ≥ 5 at baseline for CD or Partial Mayo Score ≥ 3 for UC
- Established Facebook account
- Comfortable with internet-based surveys and email
Exclusion Criteria
- If female, is pregnant or is breast feeding
- Known celiac disease or subjects with a positive screen for celiac disease (elevated tissue transglutaminase antibodies)
- Inability to provide informed consent or unwilling to participate
- Evidence of untreated infection (e.g. Clostridium difficile)
- Presence of stoma or J pouch
- Bowel surgery within 12 weeks prior to enrollment and/or has surgery planned or deemed likely for inflammatory bowel disease during the study period
- Use of tube or enteral feeding, elemental diet, or parenteral alimentation within 4 weeks prior to study initiation
Data sourced from ClinicalTrials.gov (NCT03512327). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.