Clinical Trials
NIH Establishes National Research Study Recruitment Registry
A nationwide registry has been created to match volunteers with researchers. ResearchMatch.org is a secure, user-friendly web site that is complementary to Clinicaltrials.gov. ResearchMatch will match individuals in the US with researchers who are approved to recruit volunteers. Researchers affiliated with participating Clinical and Translational Science Awards (CTSAs) institutions may use the web site during the first year of the project.
Clinical trials
Clinical trial participation is an individual, and important, decision. Clinical trials are designed to test new medications in people. Clinical trials may involve a placebo group (inactive ‘medicine’) to see if the new medication offers an advantage over current standard treatment. Some trials are ‘open label’, in which all participants receive active medications or experimental treatment.
There are many advantages to participating in clinical trials. Participants in clinical trials at a minimum receive current standard care for their disease from medical teams experienced with the disease. Clinical trials also offer the opportunity to try a new medication long before it is approved by the Food and Drug Administration.
If you choose to participate in a clinical trial, you have the right to understand fully what is expected of you, what the trial will involve and the potential risks to your health. You also have the right to withdraw your consent to participate at any time. Learn more about clinical trials, including those listed on this page, at www.clinicaltrials.gov.
Trials That May be of Interest to Our Members
Updated 4/3/2012
Eosinophilic Disorders – United States
Data and Sample Collection Study to Elucidate the Mechanisms of Eosinophilic Disorders
The purpose of this study is to elucidate the mechanisms underlying eosinophil growth, survival, migration, and function and to investigate and further characterize the pathophysiology of, clinical manifestations of, and spectrum of disease severity of eosinophilic inflammation in humans.
Inclusion Criteria: Signed informed consent obtained from the patient or parent/guardian. Assent will be obtained from all minors 11 years of age and older; Males and Females, Age 1-65 years; Carrying a diagnosis of eosinophilic gastrointestinal disease, eosinophilic inflammatory disease, or food allergy; Other inclusion criteria may include: undergoing endoscopy based on evaluation by a pediatric CCHMC gastroenterologist
Exclusion Criteria: Recent viral infection (in preceding 1-2 weeks) such as upper respiratory tract infection, tonsillitis, or gastroenteritis. Viral infections in general may suppress or alter some cellular responses, especially lymphocyte responses in vivo; Oral or esophageal infections including candidiasis in the preceding 2 weeks; Known diagnosis of another systemic or gastrointestinal inflammatory condition including, but not limited to, ulcerative colitis, Crohn's disease, indeterminate colitis, celiac disease, cystic fibrosis, or immunodeficiency; Concurrent use of systemic steroids, antihistamines, or other immunomodulatory drugs that may alter cellular responses; Concurrent use of anticoagulant medications which may alter cellular responses.
Location: Cincinnati Children's Hospital Medical Center ,Cincinnati, Ohio
Contact: Tommie M Grotjan, M.S. , tommie.grotjan@cchmc.org
Study Reference: NCT00267501
Immunopathogenesis of Food Allergy and Eosinophilic Gastrointestinal Disorders
This study will examine how the immune system responds to food allergens and examine how certain white blood cells contribute to disease in individuals with food allergies and other inflammatory diseases.
Inclusion and Exclusion Criteria available at: http://clinicaltrials.gov/ct2/show/NCT01212016?term=eosinophilic&rank=49
Location: National Institutes of Health Clinical Center, Bethesda, Maryland
Contact: Calman P Prussin, M.D., cprussin@niaid.nih.gov
Study Reference: NCT01212016
Data Bank for Eosinophilic Disorders
The purpose of this study is to conduct a translational study in patients with primary eosinophil associated gastrointestinal disorders [EGID] (e.g. eosinophilic esophagitis eosinophilic gastritis, eosinophilic enteritis [EE], eosinophilic colitis, and eosinophilic gastroenteritis [EGE]) with the aim of developing a data bank containing pertinent patient demographic information, tissue samples, and DNA, which will facilitate research on the pathophysiology of inflammatory disorders and the development of a verified successful clinical treatment program.
Inclusion Criteria:
Entry criteria prior to endoscopy: Clinical symptoms consistent with EGID (e.g. refractory abdominal pain, vomiting, dysphagia); Patients with presumed gastrointestinal reflux disease (GERD) that is refractory to therapy
Entry criteria after endoscopy: Abnormal levels of eosinophils in the gastrointestinal track
Location: Cincinnati Children's Hospital Medical Center , Cincinnati, Ohio,
Contact: Tommie Grotjan tommie.grotjan@cchmc.org
Study Reference: NCT00267475
Eosinophilic Esophagitis – United States
Study of the Efficiency of Esophageal Dilation on Patient With Eosinophilic Esophagitis (EOE)
This study is for patients who have had a food impaction and/or difficulty swallowing, who are scheduled to have endoscopy, biopsy and possibly dilatation (stretching) of the esophagus.
Inclusion Criteria: Male and female volunteers ≥18 years old; Patients with known or suspected Eosinophilic Esophagitis; Patients undergoing upper endoscopy for recent food impaction or complaint of dysphagia.
Exclusion Criteria: Use of oral corticosteroid; Significant medical conditions that in the investigator's judgment would compromise the subject's health and safety; Contraindication to esophageal dilation based on investigator's judgment; Esophageal motility abnormalities not thought to be related to Eosinophilic Esophagitis.
Location: Vanderbilt Unversity Medical Center Department of Gastroenterology
Contacts: Tina Higginbotham, MPA 615-322-4643 tina.higginbotham@vanderbilt.edu
Tonya Givens, RN, BSN 615-936-1745 tonya.givens@vanderbilt.edu
Study Reference: NCT00880906
Eosinophilic Esophagitis Databank
This study will establish a registry for participants with EoE and create a research resource that will provide further insights into EoE. While there have been several large studies of EoE, very few have focused on the roles the immune system, genetics/heredity, and the environment in EoE. The samples and information collected from participants will help to identify and understand the genetic mechanisms underlying eosinophilic esophagitis.
Inclusion Criteria: Males and Females, 6 months to 65 Years; Written informed consent/assent from participant and consent from parent/guardian for minors with agreement for genetic testing; Documented diagnosis of EoE at any time confirmed by study team (pathology report describing greater than or equal to 15 eosinophils/hpf in peak field of an esophageal biopsy. Participants with eosinophilia in extra-esophageal tissue are permitted.)
Exclusion Criteria: Participants with known infectious causes of esophageal eosinophilia such as esophageal fungus, gastric H. pylori, or systemic parasites; Participants with history of persistent eosinophilia greater than 1500 cells/mcl of blood
Locations:
Arkansas Children's Hospital, Arkansas - Contact: Anne Hiegel, 501-364-3755
National Jewish Health, Colorado - Contact: Jill Slinkard, 303-398-1618
Johns Hopkins University, Maryland - Contact: Kim Mudd, 410-502-1711
Mount Sinai School of Medicine, New York - Contact: Jessica Chao, 212-241-7637
Duke University Medical Center, North Carolina - Contact: Pam Steele, 919-668-1333
Study Reference: NCT01323803
Trial of Montelukast in Eosinophilic Esophagitis
Evaluate clinical effectiveness of oral montelukast compared to placebo on prevention of dysphagia and food impaction in patients with EE. Also evaluate tolerance and safety of oral montelukast in treatment of EE.
Inclusion Criteria: Males and Females, 18 years of age or older; > 14 eosinophils / hpf on biopsies from mid esophagus within the 6 months; Abnormal dysphagia questionnaire (Question 1a yes, question 1c >/= mild and question 2 >/= less than once a week) prior to topical steroid treatment. This questionnaire has recently been validated; Normal dysphagia questionnaire after topical steroid treatment (Having an answer of no to question 1a: Have you had trouble swallowing, not associated with other cold symptoms? over the past two weeks since having completed the swallowed steroid treatment).
Location: Mayo Clinic, Rochester, Minnesota
Contact: Contact: Christine R Kujath , kujath.christine@mayo.edu
Reference: NCT00511316
Eosinophilic Esophagitis – US, Canada, Switzerland, UK
Development, Validation and Evaluation of an Adult and Pediatric Eosinophilic Esophagitis Activity Index (EEsAI)
This investigators' 3-year project, carried out in cooperation with international EoE experts, aims at the development of an activity index for adult and pediatric EoE patients that will be used in future clinical trials as well as observational studies.
Inclusion Criteria: every patient with the diagnosis Eosinophilic Esophagitis; pediatric and adult EoE patients
Locations: 25 locations in the US, Canada, Switzerland, and the UK. Locations listed at: http://clinicaltrials.gov/ct2/show/study/NCT00939263?term=eosinophilic&rank=46&show_locs=Y#locn
Contacts: Contact listed at: http://clinicaltrials.gov/ct2/show/study/NCT00939263?term=eosinophilic&rank=46&show_locs=Y#locn
Study Reference: NCT00939263
Hypereosinophilic Syndrome – United States
Steroid Treatment for Hypereosinophilic Syndrome
The purpose of this study is to to determine whether a single-dose of prednisone can be used to predict which people with hypereosinophilia respond to treatment and to study lack of response to steroid treatment in people with HES.
Inclusion Criteria: Subject meets diagnostic criteria for HES (AEC > 1500/microL, absence of a secondary cause and signs and/or symptoms attributable to the eosinophilia); Willingness to perform the timed steroid challenge; Appropriate candidate for GC treatment after challenge; Willingness to have samples stored for future research
Exclusion Criteria: Receiving > 10 mg prednisone or equivalent at the time of enrollment; Receiving less than or equal to 10 mg of prednisone or equivalent but have not been on a fixed dose for at least 3 weeks (subjects on a current corticosteroid taper will be excluded).0; AEC less than or equal to 1500/microl at the time of enrollment; Use of immunomodulatory medications, (other than less than or equal to 10 mg/day prednisone) including but not limited to biologics, within the past 6 months; Pregnant or breastfeeding at the time of evaluation; Have a known mutation in the FIP1L1-PDGFR gene; Any condition that, in the opinion of the investigator, places the subject at undue risk by participating in the protocol; Weight less than 48 kg (106 lbs) in subjects less than 18 years of age.
Location: National Institutes of Health Clinical Center, Bethesda, Maryland
Contacts: Amara G Pabon, R.N. , pabona@mail.nih.gov
Paneez Khoury, M.D., khouryp@niaid.nih.gov
Study Reference: NCT01524536
Imatinib Mesylate to Treat Myeloproliferative Hypereosinophilic Syndrome
The purpose of this study is to evaluate the safety and efficacy of the tyrosine kinase inhibitor, imatinib mesylate (Gleevec(Trademark)) in reducing peripheral blood eosinophilia in patients with the myeloproliferative form of hypereosinophilic syndrome (HES).
A complete list of Inclusion and Exclusion Criteria can be found at http://clinicaltrials.gov/ct2/show/NCT00044304?term=Hypereosinophilic&rank=4
Location: National Institutes of Health Clinical Center, Bethesda, Maryland
Contact: Amy D Klion, M.D., aklion@nih.gov
Study Reference: NCT00044304
Churg Strauss – United States and Canada
Determining Disease Activity Biomarkers in Individuals With Churg-Strauss Syndrome
The purpose of this study is to determine new biological markers, or biomarkers, that may be used to assess the severity of this disease in people with CSS.
Inclusion/Exclusion Critieria, Locations and Contacts can be found at: http://clinicaltrials.gov/ct2/show/NCT00315380?term=Churg+Strauss&rank=6
Study Reference: NCT00315380
One-Time DNA Study for Vasculitis
The purpose of this study is to identify genes that increase the risk of developing vasculitis, a group of severe diseases that feature inflammation of blood vessels. Results of these studies will provide vasculitis researchers with insight into the causes of these diseases and generate new ideas for diagnostic tests and therapies, and will be of great interest to the larger communities of researchers investigating vasculitis and other autoimmune, inflammatory, and vascular diseases.
Inclusion/Exclusion Criteria, Locations and Contacts can be found at: http://clinicaltrials.gov/ct2/show/NCT01241305?term=Churg+Strauss&rank=11
Study Reference: NCT01241305
Churg Strauss – Multiple Countries
American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Diagnostic and Classification Criteria for Primary Systemic Vasculitis (DCVAS)
Inclusion Criteria, list of Locations and Contacts can be found at http://clinicaltrials.gov/ct2/show/study/NCT01066208?term=Churg+Strauss&rank=7&show_locs=Y#locn
Study Reference: NCT01066208
