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Clinical Research Grants
The Foundation for Clinical Research in IBD welcomes grant applications that are based on innovative clinical research — including clinical therapeutic trials — which may have significant implications in the treatment or prevention of Crohn's disease and/or ulcerative colitis.

Our Goal
Eligibility
Review Process
Funding
Request for Funding
Funded Grants
Other Funding Available

Our goal is to fund projects by young researchers or pilot clinical studies in inflammatory bowel disease that

  1. are in the preliminary stages of investigation
  2. have new and intriguing concepts that are both creative and cutting edge
  3. are not sufficiently developed to compete for funding at traditional granting sources.

All proposals must demonstrate comprehensive knowledge of the latest developments in IBD research and be based on sound scientific evidence.

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Grants will be awarded to clinical investigators with preference for younger (e.g., trainees or junior faculty) who have not yet been funded or who are under funded for a creative and/or innovative project.

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Requests for funding will usually be reviewed within 4 to 8 weeks at which time you may be invited to submit a detailed grant application.

  • A group of ad hoc reviewers who have expertise in your proposed area of investigation will evaluate your grant application.
  • Grant applications that are judged to have significant scientific merit, are innovative, and may have major implications in the management of IBD will be selected for funding.
  • Once we receive your signed grant application, we will begin the peer review process. Decisions regarding funding of a grant will be made in 8 to 10 weeks.
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Budgets should be based on the scope of the project and specific requirements.

  • Current funding should be outlined.
  • You may request funding for up to two years.
  • Generally, funding ranges between $25,000 to $50,000. However, funding levels are not fixed and can be larger or smaller.

Upon completion of your grant, you may request new funding. The Foundation will award additional funding if a review of your progress report indicates that your findings are significant and merit continued support.

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The Foundation accepts requests for funding throughout the year. Your request must be no longer than three pages — not including attachments.

Required Information
All requests for funding must include the following:

  1. Title of the project
  2. Brief description, including:
    1. specific hypothesis
    2. planned methodology
    3. data analysis
    4. anticipated outcomes
  3. Supportive data — i.e., manuscripts or preliminary results
  4. A concise and clear statement of why your proposal is relevant and significant to the therapeutic management or prevention of IBD
  5. Your qualifications — curriculum vitae or biographical profile (This information will not be counted as part of the three-page request for funding.)
  6. Brief statement about your mentor and the clinical environment in which the project is to take place
  7. The estimated total budget for the project
  8. Your email and postal addresses
  9. A letter from your mentor (one-page or less) supporting your project.

Submission of Your Request for Funding
Submission of Your Request for Funding You are encouraged to send your request for funding via email (grants@myibd.org). However, you may also send it by postal mail to:

Foundation for Clinical Research in IBD
c/o Harris Baio & McCullough
520 South Front Street
Philadelphia, PA 19147

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2006 Grants

Smoking Cessation by Smokeless Tobacco Substitution in Crohn's Disease Patients

Susan Galandiuk, a Professor of Surgery at the University of Louisville, has been awarded a $40,000 clinical research grant. She will assess the frequency by which patients with moderate-to-severe active Crohn's disease, having failed at least one prior attempt at cigarette smoking cessation, can successfully substitute a smokeless tobacco product for cigarettes. She will also look at whether patients can reduce or quit smoking entirely, as well as see the effect of this substitution on their Crohn's disease. 

Studies show that cigarette smoking worsens the symptoms of Crohn's disease. In addition, cigarette smokers who have Crohn's disease are less responsive to treatment and are more likely to have their disease recur after surgery than non-cigarette smokers. Despite these realities, smoking cessation remains difficult for most Crohn's disease patients who smoke cigarettes. 

Galandiuk hypothesizes that patients with moderate-to-severe Crohn's disease who have been unable to quit smoking cigarettes will experience significant improvement in their Crohn's disease by switching from cigarettes to a smokeless tobacco product. During the course of the 16-week study, patients with moderate-to-severe Crohn's disease who smoke a pack of cigarettes a day for at least two years and attempted to quit at least once, will be evaluated on how the smokeless tobacco product effects their ability to quit smoking cigarettes, their Crohn's disease symptoms and their overall quality of life. Patients will be evaluated through self-reported diaries and laboratory-determined changes in serum and urine nitrosamine, as well as polycyclic aromic hydrocarbon concentrations, tobacco smoke-associated hemoglobin adducts and exhaled carbon monoxide which occurs with smoking cessation and smokeless tobacco substitution. In addition, clinical response and disease activity will be evaluated at 8- and 16- weeks after cessation and substitution. Finally, quality of life also will be evaluated. It is expected that at the end of the study, 25% of patients will achieve complete smoking cessation, 50% will reduce their daily consumption of cigarettes by half and 25% will reduce their consumption of cigarettes by less than half.

If Dr. Galandiuk's findings confirm her hypothesis, substitution of cigarettes by a smokeless tobacco product may become a new tool to help Crohn's disease patients previously unable to quit cigarette smoking better manage their disease. In addition, if positive, this study will provide preliminary data to support wider clinical trials.

Tinidazole and the Prevention of Pouchitis Following Heal Pouch-Anal Anastomosis Surgery in Ulcerative Colitis

Maria T. Abreu, M.D., Director of the Inflammatory Bowel Disease Center and Associate Professor of Medicine at The Mount Sinai School of Medicine, was awarded a $34,000 clinical research grant to study the prevention of pouchitis following surgery in ulcerative colitis. The study, entitled "Tinidazole and the Prevention of Pouchitis Following Ileal Pouch-Anal Anastomosis Surgery in Ulcerative Colitis," will examine the effectiveness of the antibiotic Tinidazole in preventing pouchitis when taken at a low-dose immediately following surgery and continued for 12 months.

Pouchitis is a potentially serious complication that affects approximately half of all ulcerative colitis patients who have ileal pouch anal-anastomosis surgery, also known as the J-pouch. The J-pouch is an option for ulcerative colitis patients whose colons have been removed due to severe disease that does not respond to medical therapy or the detection of pre-cancerous or cancerous lesions. Pouchitis is generally responsive to antibiotic therapy, however, nearly 10% of pouchitis patients develop a chronic form of the disease that can be disabling and, in rare cases, result in the removal of the pouch. Currently, there is no preventive therapy routinely given for pouchitis.

It is hypothesized that the use of Tinidazole as a preventative therapy will reduce the incidence of pouchitis. If this hypothesis holds, this research will help to show the possible benefits of preventative therapy in patients receiving a J-pouch.

2005/2006 Grants

Do We Have the Correct Diagnosis? Utility of Serologic Testing for Crohn’s Disease in Patients with Ulcerative Colitis

Gil Melmed, MD, a Senior Gastroenterology Fellow at UCLA, Cedars-Sinai Inflammatory Bowel Disease Center, was awarded a $34,638 clinical research grant to determine if the presence of specific antibodies in blood samples might assist in a more precise diagnosis of patients who appear to have ulcerative colitis but who also present clinical “red flags” that indicate possible Crohn’s or small bowel disease.

Treatment guidelines – both medical and surgical – differ for Crohn’s disease and ulcerative colitis patients. Yet, it can be difficult to distinguish ulcerative colitis from Crohn’s disease in patients with colonic inflammation. Typically, physicians look for “red flags” in a patient’s clinical history to determine if Crohn’s disease is present. These clinical “red flags” include significant weight loss, non-bloody diarrhea, a first or second degree relative with Crohn’s disease, bloating, nausea, vomiting, perianal skin tags, chronic fissure or anal ulceration, perianal fistula, a history of poor or delayed maturation, or elevated CRP. Colonoscopy/ileoscopy, upper endoscopy or capsule enteroscopy are used to try to verify the presence of Crohn’s disease.

Melmed hypothesizes that serologic tests for specific antibodies may serve as markers for Crohn’s disease. During the course of his study, he will evaluate the clinical history of 104 consecutive patients with ulcerative colitis to determine if any have “red flags” for Crohn’s. These patients will undergo additional diagnostic testing for small bowel disease and blinded serologic evaluation for antibodies, including ASCA (IgA, IgG), OMPC, I2, CBir1, and pANCA.

If his findings confirm his hypothesis, serologic testing of ulcerative colitis patients may become a valuable tool in achieving an accurate diagnosis and providing appropriately tailored management strategies. In addition, a positive outcome could have critical importance for the selection of patients with ulcerative colitis for clinical trials.

2004 Grants

Pregnancy Outcomes in Women with Inflammatory Bowel Disease:
A Population Based Study


Uma Mahadevan, MD, at the University of California, San Francisco, Center for Colitis and Crohn's Disease was awarded a $34,500 clinical research grant to complete a study of pregnancy outcomes in women with IBD.

The study is the first population-based, retrospective cohort analysis specifically addressing the questions of immunosuppressive use and disease activity in IBD (stratified by type), during the conception and gravid period and their effect on maternal and fetal outcomes.

The study group was drawn from the three million members of the Northern California Kaiser Permanente (NCKP) health plan who became pregnant between 1994-2002 and were between the ages of 16-45 years at the time their charts were abstracted. "We have identified 493 women with IBD who had a pregnancy and matched them with 493 controls without IBD," says Dr. Mahadevan. "At this time, 314 cases and 432 controls have been abstracted. We have also completed 300 telephone questionnaires."

Once completed, the study will expand existing knowledge of conception and pregnancy in IBD patients, providing guidelines and reasonable risk assessment for care.

Prospective Controlled Assessment of Wireless Capsule Endoscopy in Ulcerative Colitis

Andrew S. Ross, MD, and David T. Rubin, MD, at The University of Chicago Hospitals, Section of Gastroenterology, received a $22,976 clinical research grant to determine the prevalence of small bowel pathology in patients diagnosed with ulcerative colitis (UC) using Wireless Capsule Endoscopy (WCE).

Based on the inaccuracies of the current classification scheme for IBD, Ross and Rubin hypothesize that a significant proportion of patients with UC will have small bowel involvement. If their hypothesis proves to be correct, the results will indicate a change in diagnosis to Crohn's disease or the recognition of a new phenotype of IBD.

The study group will include 58 patients with active UC and 58 individuals who do not have IBD and who are free of gastrointestinal symptoms. Demographic data will be recorded for patients in both groups. Information regarding symptoms and diagnosis — including any previous diagnostic testing — of individuals in the UC group also will be recorded. All participants will undergo a WCE in addition to phlebotomy to determine the presence of IBD serologies.

Two experienced, independent examiners, blinded to the study group, will read and interpret each of the studies.

"We hope that the information obtained from this investigation," writes Dr. Ross, "will aid in the current efforts to reclassify IBD using improved endoscopic and imaging technologies, genotype and serologic analysis."

2003 Grants

Probiotic Preparation (VSL#3) for the Treatment of Children and Adolescents with Inflammatory Bowel Disease

Robert Baldassano, MD, at the Children's Hospital of Philadelphia received a $10,000 clinical research grant in 2003 to assess the ability of a probiotic preparation (VSL#3) to achieve a complete and rapid wean of corticosteroid therapy in patients with Crohn's disease. In addition, he will assess the safety and tolerability of the probiotic preparation and the changes in intestinal microflora as a result of treatment with the probiotic preparation.

In a prospective, placebo-controlled, double-blind study, Dr. Baldassano will administer one oral packet of VSL#3 or placebo daily for ten weeks to 33 pediatric Crohn's disease patients who are currently receiving the equivalent of 40 mg of prednisone to treat active Crohn's disease.

VSL#3 is a patented probiotic therapy that contains eight strains of live, healthy bacteria. Preliminary clinical studies indicate that VSL#3 may improve intestinal microbial balance and thus might control inflammation in IBD.

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WeCare Small Grants Available for Women Fellows or Instructors for DDW - April 15 Deadline

The WeCare Small Grants program encourages trainees to pursue a career in IBD, especially women investigators, and provides travel support to MD and PhD postdoctoral fellows or junior faculty so
they may present their abstracts at the 2008 DDW annual meeting. Up to four awards of $2,000 will be given to selected individuals chosen to present
outstanding abstracts of which they are first authors at the 2008 DDW annual meeting. Download the application PDF here. Deadline April 15th.

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Contact us if you have question about the Foundation’s clinical research grants.
 
 

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