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Autoimmune Protocol Diet and Inflammatory Bowel Disease | Clinical Trials | Clareo Health

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Autoimmune Protocol Diet and Inflammatory Bowel Disease

Efficacy of the Autoimmune Protocol Diet for Inflammatory Bowel Disease

NCT03512327•Scripps Health

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

September 1, 2016

Primary Completion Date

December 10, 2016

Completion Date

December 10, 2016

Last Updated

January 9, 2025

Enrollment

ACTUAL participants

Conditions

Crohn DiseaseUlcerative ColitisInflammatory Bowel Diseases

Interventions

Autoimmune protocol (AIP) diet

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Autoimmune Protocol Diet and Inflammatory Bowel Disease

Inclusion Criteria

Exclusion Criteria

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