Autoimmune Protocol Diet and Inflammatory Bowel Disease

NCT ID: NCT03512327

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2016-12-10

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

Conditions

Crohn Disease; Ulcerative Colitis; Inflammatory Bowel Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autoimmune protocol (AIP) diet

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

Group Type: EXPERIMENTAL

Autoimmune protocol (AIP) diet

Intervention Type: OTHER

Autoimmune protocol diet, designed as a 6 week step wise elimination phase followed by 5 week maintenance phase.

Interventions

Autoimmune protocol (AIP) diet

Autoimmune protocol diet, designed as a 6 week step wise elimination phase followed by 5 week maintenance phase.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scripps Health

OTHER

Sponsor Role: lead

Responsible Party

Gauree G. Konijeti

Physician, Clinical Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gauree G Konijeti, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Gastroenterologist, Clinical Investigator

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

16-6774

Identifier Type: -

Identifier Source: org_study_id