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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. Expansion to other institutions is expected by 2011.
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 at . Trials That May be of Interest to Our Members
Eosinophilic Esophagitis Trials
Protocol: A Double-blinded , randomized, placebo-controlled trial of Intravenous QAX576 in the treatment of Eosinophilic Esophagitis
Site: Stanford University CA Contact Tessa Hunter (research coordinator) at (650) 723-8461. Investigator: Kari Nadeau MD, PhD
Protocol: A Double-blinded , randomized, placebo-controlled trial of intravenous QAX576 in the treatment of Eosinophilic Esophagitis. Please see the Study Synopsis on the Clinical Trials website. http://clinicaltrials.gov/ct2/show/NCT01022970?term=EoE+and+Novartis&rank=1
New Clinical Trial for adult patients (age 18-50) with eosinophilic esophagitis (EoE)
Where: The Cincinnati Center for Eosinophilic Disorders at Cincinnati Children's Hospital Medical Center The study will test a new medicine called QAX576. Intravenous QAX576 works by blocking an immunological protein (hormone) called IL-13.
For more information CCED website at http://www.cincinnatichildrens.org/svc/alpha/e/eosinophilic/research/studies/qax576-treatment.htm
or contact the investigator or research coordinator. www.clinicaltrials.gov ClinicalTrials.gov Identifier: NCT01022970 Investigator: Marc E. Rothenberg, MD, PhD rothenberg@cchmc.org 513-636-7210 Research Coordinator: Allison Greenberg allison.greenberg@cchmc.org 513-803-2683
Eosinophilic Esophagitis (Now enrolling for drug trial) Randomized, double-blinded, drug trial assessing the efficacy of swallowed Flovent® vs. placebo for the treatment of eosinophilic esophagitis (EE).
Inclusion Criteria: Males and females ages 3-21 years, diagnosis of EE with characteristic endoscopic and histopathologic findings, referral to allergist prior to treatment.
Exclusion criteria: History of poor tolerance to fluticasone propionate, patients on inhaled glucocorticoids, patients treated with systemic steroids within the last 3 months.
Contact for Referrals:
1. Clinical Research Coordinator IV, Division of Allergy and Immunology, Eosinophilic
Team Cincinnati Children's Hospital Medical Center 3333 Burnet Ave, Cincinnati, Oh
45229-3039 (513) 636-1317
2. University of Utah, Dr. Gerald Gleich Sarah Burke Sarah.burke@hsc.utah.edu or
801.581.6465
3. The Children's Hospital of Philadelphia
PI: Jonathan Spergel, Coordinator: Kathy Pinzone, contact
info pinzone@email.chop.edu ; 215 590 9959
4. Rocky Mountain Region: The Children's Hospital Denver PI- Glenn T. Furuta
Clinical Research Coordinator: Sheryl Faut, RN., contact information
faut.sheryl@tchden.or ; 720-777-4691
Eosinophilic Esophagitis Trials
Northwestern University Feinberg School of Medicine
Quality of Life Study for Adult age 18 years or older
Are you 18 years of age or older with a diagnosis of Eosinophilic Esophagitis? The Center for Eosinophilic Diseases at Northwestern University Feinberg School of Medicine is conducting a research study to better understand the effects Eosinophilic Esophagitis may have on quality of life. This study involves completing several questionnaires about your illness and well-being and should take you about 45 minutes to complete. If you would like to participate, you may do so online by clicking this link: https://www.surveymonkey.com/s/HLY59Y5
Your information will be kept completely anonymous and participation is voluntary. If you have questions about this study, you may contact Dr. Tiffany Taft at ttaft@northwestern.edu.
Eosinophilic Esophagitis Trials
Eosinophilic esophagitis (EE) is a disease that has become increasingly recognized in children and adults over the last decade.[1] It is characterized by an accumulation of eosinophils in the esophagus in association with symptoms that frequently mimic gastro-esophageal reflux disease (GERD).[2] Specifically, patients typically report symptoms that include difficulty feeding and failure to thrive in younger children, as well as vomiting, epigastric or chest pain, dysphagia, and food impaction.[2] The diagnosis must be made on the basis of an esophageal biopsy demonstrating the presence of significant numbers of eosinophils, clinical symptoms, and the absence of acid reflux or failure to respond to acid reduction therapy. [1]
Allergic responses have been strongly implicated in the etiology of EE. [1] The overexpression of the cytokine IL-5 by T helper type 2 cells is thought to play a major role in the pathogenesis of the disease. [1] Therapies currently utilized for EE include severely restricted diets, including an elemental formula diet typically administered by nasogastric or gastrostomy tube. [2] There are no approved pharmacologic therapies for EE, although corticosteroids are sometimes administered to patients.
[1] Furuta, G.., Liacouras, C., et al. Eosinophilic Esophagitis in Children and Adults: A Systemic Review and Consensus Recommendations for Diagnosis and Treatment. Gastroentergology 2007:133:1342-1363
[2] Blanchard, C., Wang, N., Rothenberg, M. Eosinophilic esophagitis: Pathogenesis, genetics, and therapy. J. Allergy Clin Immun. November 2006 (Vol. 118, Issue 5, Pages 1054-1059)
Oral Viscous Budesonide Suspension (MB-7) in Subjects With Eosinophilic Esophagitis: A Randomized, Placebo-Controlled, Dose-Ranging Study in Children and Adolescents
Purpose
This is a randomized, placebo-controlled, parallel-arm, dose-ranging study in subjects with eosinophilic esophagitis, 2-18 years of age. Eligible subjects will be randomized into one of four treatment groups. The Treatment Period will be 12 weeks during which subjects will visit the clinic at study weeks 0 (Baseline Visit), 2, 4, 8 and 12 (Final Treatment Evaluation) for clinical symptom assessment and safety evaluation (including adverse events and vital signs). All study treatments (active drug and placebo) will be administered orally twice daily during the Treatment Period, once in the morning after breakfast and once in the evening at bedtime.
Reslizumab is a humanized mAb against IL-5. IL-5 plays a crucial role in the maturation, growth and chemotaxis of eosinophils, inflammatory cells implicated in a number of allergic diseases. The study (Res-05-0002) is a randomized, double-blind trial of reslizumab versus placebo in the treatment of pediatric patients between 5 and 18 years of age with poorly-controlled EE. Subjects will be randomized to one of three active dose groups or placebo, administered at monthly intervals for four months. The co-primary endpoints of the study are changes in clinical symptoms and esophageal eosinophil levels at the end of therapy. The clinical study is being conducted at multiple centers and will enroll approximately 172 patients. For more information on this clinical trial, please visit www.clinicaltrials.gov [Identifier: NCT00538434].
This study is a randomized clinical trial to evaluate 3 doses of mepolizumab in pediatric patients with eosinophilic esophagitis. The study will assess the safety and tolerability of mepolizumab, as well as its pharmacokinetics and capacity to decrease esophageal eosinophils. The patients eligible for enrollment in this study are those whose disease has not been adequately treated by other eosinophilic esophagitis therapies or those who are intolerant of these other treatments, including dietary therapies.
This study is open for recruitment. For further information: Clinical Trials.gov
EoE Twin Study
New Reflux-like Genetic Disease Impacting Families – a disease of twins?
Eosinophilic Esophagitis (EE) is an allergic disorder that occurs in the Esophagus. Its prevalence is climbing with widespread awareness and education to families and physicians alike. In EE, the esophagus has a high count or infiltration of white blood cells called Eosinophils. Symptoms of the disorder are different depending on age, but the most prevalent are reflux, difficulty swallowing, food impactions, nausea, abdominal pain, poor weight gain, vomiting, and poor appetite. For children and parents living with this disorder, treatment options range from a restricted diet to the use of a swallowed steroid. These methods can help keep the esophagus healthy and reduce the array of symptoms.
EE can occur in multiple members of families. A recent study published in Clinical Gastroenterology and Hepatology (Collins MH, Blanchard C, Abonia JP, Kirby C, Akers R, Wang N, et al) reported that there was a familial pattern of inheritance of EE in 26 families. Prior studies have shown a sibling risk ration of over 60-fold, meaning that twins have a great risk of co-developing EE if one twin already has EE. Based on this, EE should be considered in symptomatic family members of patients who have EE. Further, this serves as rationale to conduct further research on siblings and twins with EE.
The Cincinnati Center for Eosinophilic Disorders (CCED) at Cincinnati Children's Hospital Medical Center is a multi-disciplined team that provides leading, specialized care for Eosinophilic Patients and is conducting leading research on this problem.
For information on this study, please contact Alexa Greenler at 513-803-3078 or email alexandria.greenler@cchmc.org
For more information about EE or the CCED or to schedule an appointment, please call 513-636-2233 (CCED) or 1-800-344-2462, ext. 6-2233 or email cced@cchmc.org.
EGID Trials
NIH Eosinophilic Gastroenteritis Research Study (PDF)
Registry for Eosinophilic Gastrointestinal Disorders (REGID)
The project will allow participating centers to build a database of research-accessible clinical information for thousands of patients coping with eosinophilic disorders. The registry will help researchers find patients for clinical trials, compare treatment outcomes, and expand knowledge about these unusual conditions.
For more information, go to www.regid.org
HES Trials
Clinical Trials for Idiopathic HES
Intravenous Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES)
Hypereosinophilic syndrome (HES) is a rare disease
characterized by the triad of persistent peripheral
eosinophilia of 1500 eosinophils/mL, various end-organ injury (including skin, heart, lung,
nervous system and digestive system, etc), and exclusion of
known secondary causes of hypereosinophilia.
The major therapy for HES has been systemic corticosteroid
(‘steroids’) and other chemotherapeutic drugs (hydroxyurea,
interferon, and others) to lower eosinophilia and therefore to
slow down the progression of disease. Corticosteroids and
other therapies effectively reduce eosinophilia in some
patients, but many eventually either develop
significant side effects or diminished response to therapy.
Long-term therapeutic options therefore are limited.
Mepolizumab is a humanized monoclonal antibody that binds
specifically to human interleukin 5 (hIL-5) and inhibits its
activity. Previous human experience has shown it has
significant effect in reducing blood eosinophilia in atopic
and HES patients and can alleviate some HES clinical signs and
symptoms with a good safety profile. This study intends to
further evaluate the corticosteroid-sparing and clinical
benefit of mepolizumab in HES with a randomized
placebo-controlled trial.
CSS Trials
Churg-Strauss Syndrome Genetics Study
Investigators at the Asthma Research Center of Harvard’s Brigham & Women’s Hospital in Boston are looking for individuals with Churg-Strauss Syndrome to participate in a research study. Following confirmation of Churg-Strauss diagnosis by medical history review, the study involves donation of blood and filling out of questionnaires. Up to $50 will be paid for time and expenses.
For more information:
Call Dr. Michael Wechsler at 617-732-8202 or email mwechsler@partners.org.
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