Autoimmune Protocol Diet and Inflammatory Bowel Disease

Scripps Health

Status: Completed

Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases; Crohn Disease

Treatments: Other: Autoimmune protocol (AIP) diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03512327

16-6774

Details and patient eligibility

About

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).

Full 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

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Autoimmune protocol (AIP) diet

Experimental group

Description:

Adult patients with active Crohn's disease or ulcerative colitis, undergoing 11 week autoimmune protocol diet, to examine therapeutic efficacy

Treatment:

Other: Autoimmune protocol (AIP) diet