Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04757181
Study type Interventional
Source University of Massachusetts, Worcester
Contact
Status Completed
Phase N/A
Start date February 1, 2017
Completion date June 1, 2019

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04046913 - The ADDapt Diet in Reducing Crohn's Disease Inflammation N/A
Active, not recruiting NCT04989907 - A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Switzerland
Recruiting NCT05316584 - A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy N/A
Active, not recruiting NCT04990258 - A 24-month Real Life PErsistence Efficacy and Safety Study in IBD Patients in REMission Switched From Intravenous Infliximab to Subcutaneous Infliximab CT-P13 Remsima®SC
Completed NCT06216223 - Laser Versus Surgery in Anal Diseases in Inflammatory Bowel Patients N/A
Enrolling by invitation NCT06015789 - Self-care in Patients Affected by Inflammatory Bowel Disease and Caregivers' Contribution to Self-care
Recruiting NCT06065995 - StoMakker Mobile Application N/A
Recruiting NCT03282786 - Comparison of Carbon Dioxide (CO2) to Air Insufflation in Colonoscopy in Patients With Inflammatory Bowel Disease N/A
Recruiting NCT06002074 - SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases N/A
Recruiting NCT04960826 - Study of an Environmental Risk Factor in Crohn's Disease
Recruiting NCT05413941 - Internet-based Cognitive Behavioral Therapy in Inflammatory Bowel Disease N/A
Completed NCT03668249 - A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)
Completed NCT00721812 - A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 Phase 1
Recruiting NCT05809999 - IBD Neoplasia Surveillance RCT N/A
Recruiting NCT04138225 - The Ecological Role of Yeasts in the Human Gut
Recruiting NCT04991324 - Cholecalciferol Comedication in IBD - the 5C-study Phase 3
Completed NCT03173144 - Chronic Inflammatory Disease, Lifestyle and Treatment Response
Not yet recruiting NCT05043818 - A Clinical Study on the Screening of Intestinal Biomarkers in IBD Patients With Depression
Recruiting NCT03042091 - Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery Early Phase 1
Not yet recruiting NCT02858557 - The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases N/A