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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autoimmune protocol (AIP) diet | Experimental | Adult patients with active Crohn's disease or ulcerative colitis, undergoing 11 week autoimmune protocol diet, to examine therapeutic efficacy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autoimmune protocol (AIP) diet | Other | Autoimmune protocol diet, designed as a 6 week step wise elimination phase followed by 5 week maintenance phase. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Remission for Crohn's Disease | 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. | 11 weeks |
| Number of Participants With Clinical Remission for Ulcerative Colitis | 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. | 11 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Mucosal Healing for Crohn's Disease or Ulcerative Colitis | Number of participants with Crohn's disease or ulcerative colitis who have absence of erosions or ulcers on endoscopy or imaging | 11 weeks |
| Changes in Inflammatory Biomarkers, Including C-reactive Protein (CRP), During Dietary Intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gauree G Konijeti, MD, MPH | Gastroenterologist, Clinical Investigator | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Clinical Remission for Crohn's Disease | 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. | 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. | Posted | Count of Participants | Participants | 11 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small bowel obstruction | Gastrointestinal disorders | Non-systematic Assessment | Small bowel obstruction due to significant roughage intake |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Crohn's disease flare | Gastrointestinal disorders | Non-systematic Assessment | Increase in gastrointestinal symptoms at week 6 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gauree Konijeti | Scripps Clinic | 8585548880 | konijeti.gauree@scrippshealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2016 | Apr 27, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C103265 | aryl hydrocarbon receptor-interacting protein |
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Number of Participants with a change in C-reactive Protein Levels (inflammatory biomarker) from baseline to 11 weeks. |
| 11 weeks |
| Changes in Inflammatory Biomarkers, Including Fecal Calprotectin (FC), During Dietary Intervention | Number of Participants with a change in fecal calprotectin levels (inflammatory biomarker) from baseline to 11 weeks. | 11 weeks |
| Major Biological Processes Gene Ontology Terms Enriched in Downregulated and Upregulated Genes | 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 | 11 weeks |
| Changes in Fecal Microbiome Composition During Dietary Intervention | Changes in fecal microbiome composition at baseline and at weeks 2, 4, 6, and 11 using 16S ribosomal RNA sequencing | 11 weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Number of Participants With Clinical Remission for Ulcerative Colitis | 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. | 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. | Posted | Count of Participants | Participants | 11 weeks |
|
|
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| Secondary | Number of Participants With Mucosal Healing for Crohn's Disease or Ulcerative Colitis | Number of participants with Crohn's disease or ulcerative colitis who have absence of erosions or ulcers on endoscopy or imaging | Of the 15 participants in this study, 7 had available followup endoscopic data available for assessment of mucosal healing. | Posted | Count of Participants | Participants | 11 weeks |
|
|
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| Secondary | Changes in Inflammatory Biomarkers, Including C-reactive Protein (CRP), During Dietary Intervention | Number of Participants with a change in C-reactive Protein Levels (inflammatory biomarker) from baseline to 11 weeks. | Of the 15 participants in this trial, 9 participants had available CRP data at the end of the study to evaluate changes in CRP. | Posted | Count of Participants | Participants | 11 weeks |
|
|
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| Secondary | Changes in Inflammatory Biomarkers, Including Fecal Calprotectin (FC), During Dietary Intervention | Number of Participants with a change in fecal calprotectin levels (inflammatory biomarker) from baseline to 11 weeks. | Of the 15 participants in the study, 6 patients had available fecal calprotectin data at 11 weeks for comparison | Posted | Count of Participants | Participants | 11 weeks |
|
|
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| Secondary | Major Biological Processes Gene Ontology Terms Enriched in Downregulated and Upregulated Genes | 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 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. | Posted | Number | Enriched Gene Ontology Terms | 11 weeks |
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| Secondary | Changes in Fecal Microbiome Composition During Dietary Intervention | Changes in fecal microbiome composition at baseline and at weeks 2, 4, 6, and 11 using 16S ribosomal RNA sequencing | 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. | Posted | 11 weeks |
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| 0 |
| 15 |
| 1 |
| 15 |
| 1 |
| 15 |
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| D003092 | Colitis |
| D003108 | Colonic Diseases |