NCT03512327

Autoimmune Protocol Diet and Inflammatory Bowel Disease

Completed NA Results posted Last updated 9 January 2025

What this trial tests

NA trial testing Autoimmune protocol (AIP) diet in Crohn Disease in 15 participants. Completed in 10 December 2016.

Timeline

1 September 2016

Primary endpoint
10 December 2016

10 December 2016

Quick facts

Lead sponsor	Scripps Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	1 September 2016
Primary completion	10 December 2016
Estimated completion	10 December 2016

Drugs / interventions tested

• Autoimmune protocol (AIP) diet

Conditions studied

• Crohn Disease — all drugs for Crohn Disease →
• Ulcerative Colitis — all drugs for Ulcerative Colitis →
• Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →

Sponsor

Scripps Health — full company profile →

Who can join

18 and older, any sex, with Crohn Disease or Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Clinical Remission for Crohn's Disease Primary · 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.

Group	Value	95% CI
Participants With Crohn's Disease	6

Number of Participants With Clinical Remission for Ulcerative Colitis Primary · 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.

Group	Value	95% CI
Participants With Ulcerative Colitis	5

Number of Participants With Mucosal Healing for Crohn's Disease or Ulcerative Colitis Secondary · 11 weeks

Number of participants with Crohn's disease or ulcerative colitis who have absence of erosions or ulcers on endoscopy or imaging

Group	Value	95% CI
Participants With Crohn's Disease or Ulcerative Colitis	7

Changes in Inflammatory Biomarkers, Including C-reactive Protein (CRP), During Dietary Intervention Secondary · 11 weeks

Number of Participants with a change in C-reactive Protein Levels (inflammatory biomarker) from baseline to 11 weeks.

Group	Value	95% CI
Participants With Crohn's Disease or Ulcerative Colitis	9

Changes in Inflammatory Biomarkers, Including Fecal Calprotectin (FC), During Dietary Intervention Secondary · 11 weeks

Number of Participants with a change in fecal calprotectin levels (inflammatory biomarker) from baseline to 11 weeks.

Group	Value	95% CI
Patients With Crohn's Disease or Ulcerative Colitis	6

Major Biological Processes Gene Ontology Terms Enriched in Downregulated and Upregulated Genes Secondary · 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

Group	Value	95% CI
Patients With Ulcerative Colitis	10

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Autoimmune Protocol (AIP) Diet

Serious: 1/15 (7%)

Deaths: 0/15

Serious adverse events (1 terms)

Reaction	System	Autoimmune Protocol (AIP) …
Small bowel obstruction	Gastrointestinal disorders	—

Other adverse events (1 terms — click to expand)

Reaction	System	Autoimmune Protocol (AIP) …
Crohn's disease flare	Gastrointestinal disorders	—

Most-reported serious reactions: Small bowel obstruction.

Data from ClinicalTrials.gov NCT03512327 adverse events section.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. An Autoimmune Protocol Diet Improves Patient-Reported Quality of Life in Inflammatory Bowel Disease.
   Chandrasekaran A, Groven S, Lewis JD, Levy SS, et al · · 2019 · cited 10× · PMID 31832627 · DOI 10.1093/crocol/otz019
2. The Autoimmune Protocol Diet Modifies Intestinal RNA Expression in Inflammatory Bowel Disease.
   Chandrasekaran A, Molparia B, Akhtar E, Wang X, et al · · 2019 · cited 4× · PMID 32309803 · DOI 10.1093/crocol/otz016