Autoimmune Protocol Diet and Inflammatory Bowel Disease

Not Applicable

Completed

• Conditions: Crohn Disease; Inflammatory Bowel Diseases; Ulcerative Colitis
• Interventions: Other: Autoimmune protocol (AIP) diet

• Registration Number: NCT03512327
• Lead Sponsor: Scripps Health

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

Study Timeline

• Study Start: 2016-09-01
• Primary Completion: 2016-12-10
• Study Completion: 2016-12-10
• Study First Submitted: 2018-02-26
• Study First Submitted QC: 2018-04-27
• Study First Posted: 2018-04-30
• Results First Submitted: 2024-01-12
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-28
• Last Update Submitted: 2024-12-28
• Results First Posted: 2025-01-09
• Last Update Posted: 2025-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autoimmune protocol (AIP) diet	Autoimmune protocol (AIP) diet	Adult patients with active Crohn's disease or ulcerative colitis, undergoing 11 week autoimmune protocol diet, to examine therapeutic efficacy

Primary Outcome Measures

Name	Time	Method
Number of Participants With Clinical Remission for Crohn's Disease	11 weeks	Clinical disease activity scores will be measured by Harvey Bradshaw Index 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. The Harvey Bradshaw Index ranges from 0-16, with lower values representing better outcome and higher values representing more disease activity. Clinical remission is defined as Harvey Bradshaw Index \<5 for CD.
Number of Participants With Clinical Remission for Ulcerative Colitis	11 weeks	Clinical disease activity scores will be measured by Mayo score for patients with ulcerative colitis (UC). The Mayo score includes measures of stool frequency, rectal bleeding, physician global assessment, and endoscopic assessment. The Mayo score ranges from 0-12, with lower values representing better outcome and higher values representing more disease activity. Clinical remission is defined as Mayo score 2 or less for UC.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Mucosal Healing for Crohn's Disease or Ulcerative Colitis	11 weeks	Number of participants with Crohn's disease or ulcerative colitis who have absence of erosions or ulcers on endoscopy or imaging
Changes in Inflammatory Biomarkers, Including C-reactive Protein (CRP), During Dietary Intervention	11 weeks	Number of Participants with a change in C-reactive Protein Levels (inflammatory biomarker) from baseline to 11 weeks.
Changes in Inflammatory Biomarkers, Including Fecal Calprotectin (FC), During Dietary Intervention	11 weeks	Number of Participants with a change in fecal calprotectin levels (inflammatory biomarker) from baseline to 11 weeks.
Major Biological Processes Gene Ontology Terms Enriched in Downregulated and Upregulated Genes	11 weeks	Description of changes in RNA expression from colonic biopsies from patients with ulcerative colitis from baseline to end of study (11 weeks). Specifically, examined top 10 major Biological Processes Gene Ontology Terms Enriched in Downregulated and Upregulated Genes
Changes in Fecal Microbiome Composition During Dietary Intervention	11 weeks	Changes in fecal microbiome composition at baseline and at weeks 2, 4, 6, and 11 using 16S ribosomal RNA sequencing