Autoimmune Protocol Diet and Inflammatory Bowel Disease

Ulcerative Colitis Clinical Trial

Official title:

Efficacy of the Autoimmune Protocol Diet for Inflammatory Bowel Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03512327
• Other study ID #: 16-6774
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: December 10, 2016

Study information

• Verified date: April 2018
• Source: Scripps Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 10, 2016
• Est. primary completion date: December 10, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

Other:
• Autoimmune protocol (AIP) diet
Autoimmune protocol diet, designed as a 6 week step wise elimination phase followed by 5 week maintenance phase.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Scripps Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical remission for Crohn's disease	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.	11 weeks
Primary	Clinical remission for ulcerative colitis	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.	11 weeks
Secondary	Mucosal healing	Absence of erosions or ulcers on endoscopy or imaging	11 weeks
Secondary	Changes in inflammatory biomarkers, including c-reactive protein (CRP), during dietary intervention	Compare pre-diet to post-diet values of CRP	11 weeks
Secondary	Changes in inflammatory biomarkers, including fecal calprotectin (FC), during dietary intervention	Compare pre-diet to post-diet values of FC	11 weeks
Secondary	Changes in RNA expression from colonic mucosa	RNA-seq performed on colonic biopsies from patients with UC pre- and post-dietary intervention	11 weeks
Secondary	Changes in fecal microbiome composition during dietary intervention	Assess changes in fecal microbiome composition at baseline and at weeks 2, 4, 6, and 11 using 16S ribosomal RNA sequencing	11 weeks