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Autoimmune Protocol Diet and Inflammatory Bowel Disease

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ClinicalTrials.gov Identifier: NCT03512327
Recruitment Status : Completed
First Posted : April 30, 2018
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
Gauree G. Konijeti, Scripps Health

Brief 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).

Condition or disease Intervention/treatment Phase
Crohn Disease Ulcerative Colitis Inflammatory Bowel Diseases Other: Autoimmune protocol (AIP) diet Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of the Autoimmune Protocol Diet for Inflammatory Bowel Disease
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : December 10, 2016
Actual Study Completion Date : December 10, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Autoimmune protocol (AIP) diet
Adult patients with active Crohn's disease or ulcerative colitis, undergoing 11 week autoimmune protocol diet, to examine therapeutic efficacy
Other: Autoimmune protocol (AIP) diet
Autoimmune protocol diet, designed as a 6 week step wise elimination phase followed by 5 week maintenance phase.




Primary Outcome Measures :
  1. Clinical remission for Crohn's disease [ Time Frame: 11 weeks ]
    Clinical disease activity scores will be measured by Harvey Bradshaw Index (0-16+) 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. Lower values represent better outcome. Clinical remission is defined as Harvey Bradshaw Index <5 for CD.

  2. Clinical remission for ulcerative colitis [ Time Frame: 11 weeks ]
    Clinical disease activity scores will be measured by Mayo score (range 0-12) for patients with ulcerative colitis (UC). The Mayo score includes measures of stool frequency, rectal bleeding, physician global assessment, and endoscopic assessment. Lower values represent better outcome. Clinical remission is defined as Mayo score 2 or less for UC.


Secondary Outcome Measures :
  1. Mucosal healing [ Time Frame: 11 weeks ]
    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 ]
    Compare pre-diet to post-diet values of CRP

  3. Changes in inflammatory biomarkers, including fecal calprotectin (FC), during dietary intervention [ Time Frame: 11 weeks ]
    Compare pre-diet to post-diet values of FC

  4. Changes in RNA expression from colonic mucosa [ Time Frame: 11 weeks ]
    RNA-seq performed on colonic biopsies from patients with UC pre- and post-dietary intervention

  5. Changes in fecal microbiome composition during dietary intervention [ Time Frame: 11 weeks ]
    Assess changes in fecal microbiome composition at baseline and at weeks 2, 4, 6, and 11 using 16S ribosomal RNA sequencing



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03512327


Sponsors and Collaborators
Scripps Health
Investigators
Principal Investigator: Gauree G Konijeti, MD, MPH Gastroenterologist, Clinical Investigator
  Study Documents (Full-Text)

Documents provided by Gauree G. Konijeti, Scripps Health:

Responsible Party: Gauree G. Konijeti, Physician, Clinical Investigator, Scripps Health
ClinicalTrials.gov Identifier: NCT03512327     History of Changes
Other Study ID Numbers: 16-6774
First Posted: April 30, 2018    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colitis
Colonic Diseases