The Inflammatory Bowel Disease - Anti-Inflammatory Diet (IBD-AID) (IBD-AID)
Primary Purpose
Inflammatory Bowel Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The IBD-AID
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases
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
Sites / Locations
- University of Massachusetts Medical School
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IBD patients
Arm Description
IBD patients will be used as their own control. Participants will start the study in a baseline phase (4 weeks) and intervention phase (8 weeks)
Outcomes
Primary Outcome Measures
Microbiome change after the IBD-AID
Analysis of the microbial composition of the gut and changes that correlate with diet compliance
Secondary Outcome Measures
Improvement of symptoms
Assessment of disease severity and overall quality of life before and after the IBD-AID
Improvement of inflammatory markers
Assessment of inflammatory markers in blood before and after the IBD-AID
Full Information
NCT ID
NCT04757181
First Posted
February 4, 2021
Last Updated
February 11, 2021
Sponsor
University of Massachusetts, Worcester
1. Study Identification
Unique Protocol Identification Number
NCT04757181
Brief Title
The Inflammatory Bowel Disease - Anti-Inflammatory Diet (IBD-AID)
Acronym
IBD-AID
Official Title
Influence of Diet on Microbiome and Inflammation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The study design is a single-arm, prospective, pre-post intervention trial.
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IBD patients
Arm Type
Experimental
Arm Description
IBD patients will be used as their own control. Participants will start the study in a baseline phase (4 weeks) and intervention phase (8 weeks)
Intervention Type
Other
Intervention Name(s)
The IBD-AID
Intervention Description
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.
Primary Outcome Measure Information:
Title
Microbiome change after the IBD-AID
Description
Analysis of the microbial composition of the gut and changes that correlate with diet compliance
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Improvement of symptoms
Description
Assessment of disease severity and overall quality of life before and after the IBD-AID
Time Frame
8 weeks
Title
Improvement of inflammatory markers
Description
Assessment of inflammatory markers in blood before and after the IBD-AID
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Inflammatory Bowel Disease - Anti-Inflammatory Diet (IBD-AID)
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