Autoimmune Protocol Diet and Inflammatory Bowel Disease

• ClinicalTrials.gov Identifier: NCT03512327
• Recruitment Status: Completed
• First Posted: April 30, 2018
• Last Update Posted: April 30, 2018
• Sponsor: Scripps Health
• Information provided by (Responsible Party): Gauree G. Konijeti, Scripps Health

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Crohn Disease; Ulcerative Colitis; Inflammatory Bowel Diseases	Other: Autoimmune protocol (AIP) diet	Not Applicable

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of the Autoimmune Protocol Diet for Inflammatory Bowel Disease
• Actual Study Start Date: September 1, 2016
• Actual Primary Completion Date: December 10, 2016
• Actual Study Completion Date: December 10, 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Autoimmune protocol (AIP) diet; Adult patients with active Crohn's disease or ulcerative colitis, undergoing 11 week autoimmune protocol diet, to examine therapeutic efficacy	Other: Autoimmune protocol (AIP) diet; Autoimmune protocol diet, designed as a 6 week step wise elimination phase followed by 5 week maintenance phase.

Outcome Measures

Primary Outcome Measures :

1. Clinical remission for Crohn's disease [ Time Frame: 11 weeks ]
   Clinical disease activity scores will be measured by Harvey Bradshaw Index (0-16+) for patients with Crohn's Disease (CD). The Harvey Bradshaw Index measures general well being, abdominal pain severity, number of stools daily, presence of abdominal mass, and complications. Lower values represent better outcome. Clinical remission is defined as Harvey Bradshaw Index <5 for CD.
2. Clinical remission for ulcerative colitis [ Time Frame: 11 weeks ]
   Clinical disease activity scores will be measured by Mayo score (range 0-12) for patients with ulcerative colitis (UC). The Mayo score includes measures of stool frequency, rectal bleeding, physician global assessment, and endoscopic assessment. Lower values represent better outcome. Clinical remission is defined as Mayo score 2 or less for UC.

Secondary Outcome Measures :

1. Mucosal healing [ Time Frame: 11 weeks ]
   Absence of erosions or ulcers on endoscopy or imaging
2. Changes in inflammatory biomarkers, including c-reactive protein (CRP), during dietary intervention [ Time Frame: 11 weeks ]
   Compare pre-diet to post-diet values of CRP
3. Changes in inflammatory biomarkers, including fecal calprotectin (FC), during dietary intervention [ Time Frame: 11 weeks ]
   Compare pre-diet to post-diet values of FC
4. Changes in RNA expression from colonic mucosa [ Time Frame: 11 weeks ]
   RNA-seq performed on colonic biopsies from patients with UC pre- and post-dietary intervention
5. Changes in fecal microbiome composition during dietary intervention [ Time Frame: 11 weeks ]
   Assess changes in fecal microbiome composition at baseline and at weeks 2, 4, 6, and 11 using 16S ribosomal RNA sequencing

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Sponsors and Collaborators

Scripps Health

Investigators

• Principal Investigator: Gauree G Konijeti, MD, MPH; Gastroenterologist, Clinical Investigator

  Study Documents (Full-Text)

Documents provided by Gauree G. Konijeti, Scripps Health:

Study Protocol and Statistical Analysis Plan  [PDF] March 1, 2016

More Information

• Responsible Party: Gauree G. Konijeti, Physician, Clinical Investigator, Scripps Health
• ClinicalTrials.gov Identifier: NCT03512327
• Other Study ID Numbers: 16-6774
• First Posted: April 30, 2018
• Last Update Posted: April 30, 2018
• Last Verified: April 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Crohn Disease; Intestinal Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases