The Inflammatory Bowel Disease - Anti-Inflammatory Diet (IBD-AID)

Inflammatory Bowel Diseases Clinical Trial

— IBD-AID  

Official title:

Influence of Diet on Microbiome and Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04757181
• Other study ID #: H00008033
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: February 2021
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to prospectively test the hypothesis that specific dietary modification can improve patient symptoms by promoting beneficial changes in the composition of the microbiome that, in turn, alter the immune response in such a way as to and ameliorate inflammatory conditions such as Inflammatory Bowel Disease (IBD). The potential long term benefit of this research is a validated set of efficacious dietary guidelines for persons with IBD. The potential immediate benefit to patients is symptomatic relief and healing.

Description:

The gut microbiome is the community of microbes that inhabit the gastrointestinal tract. Sequencing and analysis of the DNA and/or RNA of the gut microbiome (metagenomics) allow the identification of the species present and assess the metabolic activities they carry out. Stools are largely microbial and the metagenomics of stool can provide insights into the functioning of the gut microbiome.

Nutrient processing by the gut microbiome is fundamental to energy extraction and immune response. Until recently, investigation of nutritional approaches to treating Inflammatory bowel diseases (IBD) has been largely limited to the use of enteral and total parenteral nutrition with the aim of providing bowel rest.

The IBD Anti-inflammatory diet (IBD-AID) was developed to establish a dietary therapy to address nutritional adequacy and malabsorption issues, promote symptom relief, and assist with remission. The IBD-AID has been designed to favor colonic bacteria that degrade dietary fibers and produce short-chain fatty acids (SCFAs). SCFAs regulate the production of cytokines (TNF-α, IL-2, IL-6, and IL-10), eicosanoids, and chemokines (e.g., MCP-1 and CINC-2) by acting on macrophages and endothelial cells. High levels of SCFAs then promote a hyporesponsive immunological environment to commensal bacteria through the down-regulation of those pro-inflammatory effectors, aiding homeostasis maintenance.

This diet utilizes foods that are available in most grocery stores and is intended to be a complete diet that provide balanced nutrition. As many of the available medical treatments for inflammatory bowel disease have risks, this diet may be a safer alternative to medical treatment in this population. The nutrition recommendations are safe. Diet modification poses minimal risk.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• - 15 years of age or older

• Willingness and capacity to significantly change diet

• Willing and able to comply with scheduled visits, blood, and stool collection, and other study procedures and to complete the study

• Clinical provider (GI clinician) permission for IBD patients to participate in the intervention is required for participation in the study.

• Evidence of personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

• For children age 15 and above, the assent of the child and consent of a parent or legal guardian will be required.

• One of the following:

• diagnosis of IBD, specifically Crohn's Disease and Ulcerative Colitis

• healthy control

Exclusion Criteria:

• the presence of infection (such as C.diff) precipitating the colitis

• antibiotics taken within 3 months of study entry

• medically unstable to give consent

• on heparin or Coumadin

• Prisoners

• Subjects who do not speak or understand English, to ensure that there is consistency in teaching and educational materials.

• Subjects who self-report current pregnancy

• Patients who do not receive clinical care at UMass Memorial Health Care

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Other:
• The IBD-AID
Subjects will meet with study personnel for to fill out baseline questionnaires (approximately a 1-hour visit). Subjects will be instructed to make dietary changes based one the IBD-AID guidelines. Dietary instruction will be delivered via individual and group sessions led by trained study personnel. Participants will be expected to learn the skills of dietary change to the IBD-AID and will begin their 8 weeks compliance period followed by endpoint measures. Participants are encouraged to attend 3 cooking classes (1.5 hours duration) in our teaching kitchen.

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiome change after the IBD-AID	Analysis of the microbial composition of the gut and changes that correlate with diet compliance	8 weeks
Secondary	Improvement of symptoms	Assessment of disease severity and overall quality of life before and after the IBD-AID	8 weeks
Secondary	Improvement of inflammatory markers	Assessment of inflammatory markers in blood before and after the IBD-AID	8 weeks