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NCT Number: NCT03512327

Autoimmune Protocol Diet and Inflammatory Bowel Disease

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).

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Key information

Conditions

Crohn Disease Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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:

  • To evaluate the effect of the AIP diet on clinical and endoscopic disease activity for CD and UC,
  • To examine changes in inflammatory biomarkers during AIP diet
  • To characterize changes in RNA expression from intestinal mucosal biopsy specimens from prior to diet initiation to end of the study.
  • To characterize changes in fecal microbiome during diet intervention

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years of age
  • Able to provide written informed consent prior to screening and to comply with the requirements of the study protocol.
  • Established diagnosis of small bowel CD or colonic CD or ulcerative colitis
  • 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
  • Any medications being currently used for IBD must remain stable during the study period with the exception of tapering of corticosteroids.
  • Current disease activity defined as a Harvey Bradshaw index ≥ 5 at baseline for CD or Partial Mayo Score ≥ 3 for UC
  • Established Facebook account
  • Comfortable with internet-based surveys and email

Exclusion criteria

  • If female, is pregnant or is breast feeding
  • Known celiac disease or subjects with a positive screen for celiac disease (elevated tissue transglutaminase antibodies)
  • Inability to provide informed consent or unwilling to participate
  • Evidence of untreated infection (e.g. Clostridium difficile)
  • Presence of stoma or J pouch
  • Bowel surgery within 12 weeks prior to enrollment and/or has surgery planned or deemed likely for inflammatory bowel disease during the study period
  • Use of tube or enteral feeding, elemental diet, or parenteral alimentation within 4 weeks prior to study initiation

Treatment and study plan

Autoimmune protocol (AIP) diet

Other

Autoimmune protocol diet, designed as a 6 week step wise elimination phase followed by 5 week maintenance phase.

Primary outcomes

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

    Time frame: 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.

  2. Number of Participants With Clinical Remission for Ulcerative Colitis

    Time frame: 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 outcomes

  1. Number of Participants With Mucosal Healing for Crohn's Disease or Ulcerative Colitis

    Time frame: 11 weeks

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

  2. Changes in Inflammatory Biomarkers, Including C-reactive Protein (CRP), During Dietary Intervention

    Time frame: 11 weeks

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

  3. Changes in Inflammatory Biomarkers, Including Fecal Calprotectin (FC), During Dietary Intervention

    Time frame: 11 weeks

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

  4. Major Biological Processes Gene Ontology Terms Enriched in Downregulated and Upregulated Genes

    Time frame: 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

  5. Changes in Fecal Microbiome Composition During Dietary Intervention

    Time frame: 11 weeks

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

Sponsors and collaborators

Lead sponsor

Scripps Health

Other

Registry information

Official study title

Efficacy of the Autoimmune Protocol Diet for Inflammatory Bowel Disease

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 30, 2018
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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