Inflammatory bowel diseases (IBD), which include Crohn’s disease and ulcerative colitis, are disorders that involve the chronic inflammation of the digestive tract. At present these are chronic, life-long conditions that can be treated, but not cured and have a significant effect on a patient’s quality of life, along with a high financial and emotional burden.

The excessive accumulation of scar tissue in the intestinal wall is call intestinal fibrosis and is a common complication of inflammatory bowel disease (IBD). Intestinal fibrosis is seen in both ulcerative colitis (UC) and Crohn’s disease (CD) patients – totaling 6.8 million cases of IBD globally in 2017.1 Fibrosis is difficult to treat and generally requires surgery. Further, recurrence after surgery is common. Currently, there is no anti-fibrotic medical therapy available for IBD. Despite the relative success of biologics-based therapies, which provide better control of inflammation, their use has not decreased the rate of fibrosis.2 This observation suggests that additional biological pathways are likely important in the development of fibrosis.

  • Identify novel plasma-based protein biomarkers to diagnose fibrosis in adult IBD patients

  • Validate novel plasma-based protein biomarkers to diagnose fibrosis in adult IBD patients

  • External validation of biomarker candidates in an independent dataset contributed by industry and academic partners

This project seeks to identify and validate plasma-based diagnostic biomarkers to better detect and confirm the presence of fibrosis in Inflammatory bowel disease patients. Importantly, the project will help with patient stratification based on specific molecular fibrosis subtypes. Ultimately, this project will provide critical information needed to:

  • accurately diagnose patients with fibrosis;
  • effectively select patients for anti-fibrotic drug trials improving potential outcomes; and
  • facilitate more personalized treatment options for this common complication in IBD.


Partner With Us

The Foundation for the National Institutes of Health (FNIH) is actively seeking private-sector participation in this Project. The overall project budget for this three-year project is $6.96M. With generous in-kind contributions covering $1.8M of this, the FNIH needs a total of $5,160,503 in private funds (payable over four calendar years) to fully support the project. The below chart outlines the contributions necessary for participation as a full funding partner. Financial support at other levels and in-kind contributions are also welcome.

Funding partners may have multiple participants on the Project Team, and full-funding partners may cast one vote on project decisions. Throughout the life of the project, the FNIH will work to ensure that all partners have ample opportunity to provide input and share valuable expertise and receive broad acknowledgment for being a scientific and funding partner. The FNIH aims to secure funding commitments in Q3/Q4 2023. This will enable private partners’ active involvement in the immediate next steps of the process and ensure that project activities can begin in Q4 2023/Q1 2024.

Project Impact


Program Overview One-Pager

Program Overview Webinar

1 Kugathasan S, Denson LA, Walters TD, et al. Prediction of complicated disease course for children newly diagnosed with Crohn’s disease: a multicentre inception cohort study. Lancet. 2017;389(10080):1710-1718. https://doi.org/10.1016/S0140-6736(17)30317-3
2 Ballengee CR, Stidham RW, Liu C, et al. Association Between Plasma Level of Collagen Type III Alpha 1 Chain and Development of Strictures in Pediatric Patients With Crohn’s Disease. Clin Gastroenterol Hepatol. 2019;17(9):1799-1806. https://doi.org/10.1016/j.cgh.2018.09.008


Partner With Us

Work with the FNIH to accelerate medical breakthroughs for patients