Trial Outcomes & Findings for Autoimmune Protocol Diet and Inflammatory Bowel Disease (NCT NCT03512327)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

11 weeks

Results posted on

2025-01-09

Participant Flow

Participant milestones

Participant milestones
Measure	Autoimmune Protocol (AIP) Diet Adult patients with active Crohn's disease or ulcerative colitis, undergoing 11 week autoimmune protocol diet, to examine therapeutic efficacy Autoimmune protocol (AIP) diet: Autoimmune protocol diet, designed as a 6 week step wise elimination phase followed by 5 week maintenance phase.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Autoimmune Protocol Diet and Inflammatory Bowel Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Autoimmune Protocol (AIP) Diet n=15 Participants Adult patients with active Crohn's disease or ulcerative colitis, undergoing 11 week autoimmune protocol diet, to examine therapeutic efficacy Autoimmune protocol (AIP) diet: Autoimmune protocol diet, designed as a 6 week step wise elimination phase followed by 5 week maintenance phase.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	44 years STANDARD_DEVIATION 19 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 11 weeks

Population: In this study, 9 out of the 15 participants had Crohn's disease. The other 6 participants had ulcerative colitis, so were not included in this subgroup analysis.

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.

Outcome measures

Outcome measures
Measure	Participants With Crohn's Disease n=9 Participants Adult patients with active Crohn's disease, undergoing 11 week autoimmune protocol diet, to examine therapeutic efficacy
Number of Participants With Clinical Remission for Crohn's Disease	6 Participants

PRIMARY outcome

Timeframe: 11 weeks

Population: In this study, 6 out of the 15 participants had ulcerative colitis. The other 9 participants had Crohn's disease, so were not included in this subgroup analysis.

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.

Outcome measures

Outcome measures
Measure	Participants With Crohn's Disease n=6 Participants Adult patients with active Crohn's disease, undergoing 11 week autoimmune protocol diet, to examine therapeutic efficacy
Number of Participants With Clinical Remission for Ulcerative Colitis	5 Participants

SECONDARY outcome

Timeframe: 11 weeks

Population: Of the 15 participants in this study, 7 had available followup endoscopic data available for assessment of mucosal healing.

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

Outcome measures

Outcome measures
Measure	Participants With Crohn's Disease n=7 Participants Adult patients with active Crohn's disease, undergoing 11 week autoimmune protocol diet, to examine therapeutic efficacy
Number of Participants With Mucosal Healing for Crohn's Disease or Ulcerative Colitis	7 Participants

SECONDARY outcome

Timeframe: 11 weeks

Population: Of the 15 participants in this trial, 9 participants had available CRP data at the end of the study to evaluate changes in CRP.

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

Outcome measures

Outcome measures
Measure	Participants With Crohn's Disease n=9 Participants Adult patients with active Crohn's disease, undergoing 11 week autoimmune protocol diet, to examine therapeutic efficacy
Changes in Inflammatory Biomarkers, Including C-reactive Protein (CRP), During Dietary Intervention	9 Participants

SECONDARY outcome

Timeframe: 11 weeks

Population: Of the 15 participants in the study, 6 patients had available fecal calprotectin data at 11 weeks for comparison

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

Outcome measures

Outcome measures
Measure	Participants With Crohn's Disease n=6 Participants Adult patients with active Crohn's disease, undergoing 11 week autoimmune protocol diet, to examine therapeutic efficacy
Changes in Inflammatory Biomarkers, Including Fecal Calprotectin (FC), During Dietary Intervention	6 Participants

SECONDARY outcome

Timeframe: 11 weeks

Population: Outcome measure is descriptive. Of the 15 participants in this trial, 4 participants with ulcerative colitis had available colon biopsies at baseline and 11 weeks to examine changes in RNA expression in the colon. For all 4 participants, the 10 highest scoring Gene Ontology terms for biological processes associated with upregulated and downregulated genes were presented.

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

Outcome measures

Outcome measures
Measure	Participants With Crohn's Disease n=4 Participants Adult patients with active Crohn's disease, undergoing 11 week autoimmune protocol diet, to examine therapeutic efficacy
Major Biological Processes Gene Ontology Terms Enriched in Downregulated and Upregulated Genes	10 Enriched Gene Ontology Terms

SECONDARY outcome

Timeframe: 11 weeks

Population: Data was not collected. Fecal samples did not achieve quality control requirements in order to analyze data, so this substudy was terminated and analyses were not performed.

Changes in fecal microbiome composition at baseline and at weeks 2, 4, 6, and 11 using 16S ribosomal RNA sequencing

Outcome measures

Outcome data not reported

Adverse Events

Autoimmune Protocol (AIP) Diet

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Autoimmune Protocol (AIP) Diet n=15 participants at risk Adult patients with active Crohn's disease or ulcerative colitis, undergoing 11 week autoimmune protocol diet, to examine therapeutic efficacy Autoimmune protocol (AIP) diet: Autoimmune protocol diet, designed as a 6 week step wise elimination phase followed by 5 week maintenance phase.
Gastrointestinal disorders Small bowel obstruction	6.7% 1/15 • Number of events 1

Other adverse events

Other adverse events
Measure	Autoimmune Protocol (AIP) Diet n=15 participants at risk Adult patients with active Crohn's disease or ulcerative colitis, undergoing 11 week autoimmune protocol diet, to examine therapeutic efficacy Autoimmune protocol (AIP) diet: Autoimmune protocol diet, designed as a 6 week step wise elimination phase followed by 5 week maintenance phase.
Gastrointestinal disorders Crohn's disease flare	6.7% 1/15 • Number of events 1

Additional Information

Dr. Gauree Konijeti

Scripps Clinic

Phone: 8585548880

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place