Autoimmune Protocol Diet and Inflammatory Bowel Disease

NCT03512327 | Completed Results

• 1 other identifier: 16-6774
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Crohn Disease; Ulcerative Colitis; Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

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

  11 weeks

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

  11 weeks

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

  11 weeks

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

  11 weeks

• Changes in Fecal Microbiome Composition During Dietary Intervention

  11 weeks

Study Arms (1)

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

Other: Autoimmune protocol (AIP) diet

Interventions

Autoimmune protocol (AIP) diet OTHER

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

Autoimmune protocol (AIP) diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scripps Health: lead

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

aryl hydrocarbon receptor-interacting protein; Diet

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Results Point of Contact

• Title: Dr. Gauree Konijeti
• Organization: Scripps Clinic

konijeti.gauree@scrippshealth.org

8585548880

Study Officials

• Gauree G Konijeti, MD, MPH

  Gastroenterologist, Clinical Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Clinical Investigator

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: April 30, 2018
• Study Start: September 1, 2016
• Primary Completion: December 10, 2016
• Study Completion: December 10, 2016
• Last Updated: January 9, 2025
• Results First Posted: January 9, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share