Back to results

Autoimmune Protocol Diet and Inflammatory Bowel Disease

Primary Purpose

Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Autoimmune protocol (AIP) diet

About this trial

This is an interventional treatment trial for Crohn Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autoimmune protocol (AIP) diet

Arm Description

Adult patients with active Crohn's disease or ulcerative colitis, undergoing 11 week autoimmune protocol diet, to examine therapeutic efficacy

Outcomes

Primary Outcome Measures

Clinical remission for Crohn's disease

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.

Clinical remission for ulcerative colitis

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

Mucosal healing

Absence of erosions or ulcers on endoscopy or imaging

Changes in inflammatory biomarkers, including c-reactive protein (CRP), during dietary intervention

Compare pre-diet to post-diet values of CRP

Changes in inflammatory biomarkers, including fecal calprotectin (FC), during dietary intervention

Compare pre-diet to post-diet values of FC

Changes in RNA expression from colonic mucosa

RNA-seq performed on colonic biopsies from patients with UC pre- and post-dietary intervention

Changes in fecal microbiome composition during dietary intervention

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

Full Information

NCT ID

NCT03512327

First Posted

February 26, 2018

Last Updated

April 27, 2018

Sponsor

Scripps Health

1. Study Identification

Unique Protocol Identification Number

NCT03512327

Brief Title

Autoimmune Protocol Diet and Inflammatory Bowel Disease

Official Title

Efficacy of the Autoimmune Protocol Diet for Inflammatory Bowel Disease

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

September 1, 2016 (Actual)

Primary Completion Date

December 10, 2016 (Actual)

Study Completion Date

December 10, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Scripps Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Autoimmune protocol (AIP) diet

Arm Type

Experimental

Arm Description

Adult patients with active Crohn's disease or ulcerative colitis, undergoing 11 week autoimmune protocol diet, to examine therapeutic efficacy

Intervention Type

Other

Intervention Name(s)

Autoimmune protocol (AIP) diet

Intervention Description

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

Primary Outcome Measure Information:

Title

Clinical remission for Crohn's disease

Description

Time Frame

11 weeks

Title

Clinical remission for ulcerative colitis

Description

Time Frame

11 weeks

Secondary Outcome Measure Information:

Title

Mucosal healing

Description

Absence of erosions or ulcers on endoscopy or imaging

Time Frame

11 weeks

Title

Changes in inflammatory biomarkers, including c-reactive protein (CRP), during dietary intervention

Description

Compare pre-diet to post-diet values of CRP

Time Frame

11 weeks

Title

Changes in inflammatory biomarkers, including fecal calprotectin (FC), during dietary intervention

Description

Compare pre-diet to post-diet values of FC

Time Frame

11 weeks

Title

Changes in RNA expression from colonic mucosa

Description

RNA-seq performed on colonic biopsies from patients with UC pre- and post-dietary intervention

Time Frame

11 weeks

Title

Changes in fecal microbiome composition during dietary intervention

Description

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

Time Frame

11 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gauree G Konijeti, MD, MPH

Organizational Affiliation

Gastroenterologist, Clinical Investigator

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Autoimmune Protocol Diet and Inflammatory Bowel Disease

We'll reach out to this number within 24 hrs