Clinical trial NCT03512327: Autoimmune Protocol Diet and Inflammatory Bowel Disease
Official title: Efficacy of the Autoimmune Protocol Diet for Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn Disease
Ulcerative Colitis
Inflammatory Bowel Diseases
Lead sponsor: Scripps Health
Sponsor class: OTHER
First posted: 2018-04-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

1. At least 18 years of age
2. Able to provide written informed consent prior to screening and to comply with the requirements of the study protocol.
3. Established diagnosis of small bowel CD or colonic CD or ulcerative colitis
4. 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
5. Any medications being currently used for IBD must remain stable during the study period with the exception of tapering of corticosteroids.
6. Current disease activity defined as a Harvey Bradshaw index ≥ 5 at baseline for CD or Partial Mayo Score ≥ 3 for UC
7. Established Facebook account
8. Comfortable with internet-based surveys and email

Exclusion Criteria:

1. If female, is pregnant or is breast feeding
2. Known celiac disease or subjects with a positive screen for celiac disease (elevated tissue transglutaminase antibodies)
3. Inability to provide informed consent or unwilling to participate
4. Evidence of untreated infection (e.g. Clostridium difficile)
5. Presence of stoma or J pouch
6. Bowel surgery within 12 weeks prior to enrollment and/or has surgery planned or deemed likely for inflammatory bowel disease during the study period
7. Use of tube or enteral feeding, elemental diet, or parenteral alimentation within 4 weeks prior to study initiation

Primary outcomes:
measure: Number of Participants With Clinical Remission for Crohn's Disease
timeFrame: 11 weeks
measure: Number of Participants With Clinical Remission for Ulcerative Colitis
timeFrame: 11 weeks
Secondary outcomes:
measure: Number of Participants With Mucosal Healing for Crohn's Disease or Ulcerative Colitis
timeFrame: 11 weeks
measure: Changes in Inflammatory Biomarkers, Including C-reactive Protein (CRP), During Dietary Intervention
timeFrame: 11 weeks
measure: Changes in Inflammatory Biomarkers, Including Fecal Calprotectin (FC), During Dietary Intervention
timeFrame: 11 weeks
measure: Major Biological Processes Gene Ontology Terms Enriched in Downregulated and Upregulated Genes
timeFrame: 11 weeks
measure: Changes in Fecal Microbiome Composition During Dietary Intervention
timeFrame: 11 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Gastroenterologist, Clinical Investigator
name: Gauree G Konijeti, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: