Clinical trial NCT04757181: The Inflammatory Bowel Disease - Anti-Inflammatory Diet (IBD-AID)
Official title: Influence of Diet on Microbiome and Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 38
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study design is a single-arm, prospective, pre-post intervention trial.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Microbiome change after the IBD-AID
timeFrame: 8 weeks
Secondary outcomes:
measure: Improvement of symptoms
timeFrame: 8 weeks
measure: Improvement of inflammatory markers
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
References: