Ongoing Research Trials
All of the research studies listed have been deemed appropriate for homePEN consumers/caregivers by the Oley Research Committee; however, The Oley Foundation strongly encourages anyone considering participating in medical research to discuss the issue with their managing physician before signing up.
More information on these studies is available by calling (800) 776-OLEY. Clinicians interested in having their study listed should contact Joan Bishop at bishopj@mail.amc.edu or call (800) 776-6539
Participate in Major HPN Quality of Life (QoL) Study Download and Print
You are in a unique position to help the medical field understand the impact that home parenteral nutrition (HPN) has had on your life. Because you experience this therapy on a day-to-day basis, we are asking you to participate in a widespread study of the effect of HPN on quality of life.
The Oley Foundation is collaborating with the European Home Artificial Nutrition Workgroup in this study. The study will promote understanding of the issues that are important to you, the consumer, and will hopefully make HPN practices better for you, as well as for those elsewhere. It may also make it possible to compare the effects of techniques such as small intestinal transplantation with life on HPN to allow consumers to make more informed decisions, and to compare HPN practices in the United States with those in European countries. Developing this understanding further could also help us make Oley of greater benefit to you.
How to Participate
This study is open to all adult HPN consumers. You do not have to be an Oley member to participate. We heartily encourage your participation. For details and/or to participate, contact the Oley office at 800-776-OLEY or e-mail Cathy Harrington at harrinc@mail.amc.edu details. All responses will be kept confidential. This study has been approved by the Albany Medical Center Institutional Review Board (IRB).
Study for Parents of Children with Undiagnosed Medical Condition
If you have a child with a medical condition that has been ongoing for longer than two years and for which you have not received a conclusive diagnosis, you are invited to participate in a research study sponsored by the National Human Genome Research Institute, one of the National Institutes of Health.
The study involves filling out a forty-minute survey that asks for your thoughts and feelings about having a child or children with an undiagnosed medical condition, as well as questions about your everyday life. There are no personal benefits to you from taking part in this study. However, by sharing your experiences you may help improve health care and counseling for other parents of children with undiagnosed medical conditions.
If you would like to fill out the survey online, go to www.surveymonkey.com/SurveyExperienceUncertainty. The password to enter the survey is: Uncertainty. For more information or if you would like to complete a paper copy of the survey, contact Anne C. Madeo, MS, CGC, Principal Investigator; National Human Genome Research Institute; National Institutes of Health; (301) 443-2635; Anne.Madeo@nih.gov.
Note that you will not be paid for participating in this study, and the study is completely anonymous.
Study Investigates Whether Teduglutide (GLP2) Can reduce HPN Dependency
Patient enrollment is underway in a Phase 3 study to confirm previously reported data that demonstrated teduglutide was well tolerated and significantly reduced parenteral nutrition (PN) dependence in short bowel syndrome or SBS patients. Teduglutide is a proprietary analog of human glucagon-like peptide 2 that stimulates the repair and regeneration of cells lining the intestine. This international, double-blind, placebo-controlled safety and efficacy study is known as STEPS (Study of TEduglutide in PN-dependent Short-bowel syndrome). STEPS will compare daily subcutaneous dosing of 0.05 mg/kg of teduglutide to placebo over a 24-week treatment period. After completing 24-weeks, patients will be offered the option to enter an open-label extension phase for up to an additional 24 months, in which patients previously treated with teduglutide or placebo will receive teduglutide.
For more information on STEPS, please contact NPS Pharmaceuticals, Inc. www.npsp.com or 908-450-5300.
Study Director: Bo Joelsson, MD, PhD NPS Pharmaceuticals
Contact: Eric Kim NPS Pharmaceuticals ekim@npsp.com
Hirschsprung Disease Genetics Study
Dr. Aravinda Chakravarti’s laboratory at Johns Hopkins University has been investigating the genetics of Hirschsprung disease (HSCR) for more than fifteen years. The purpose of our study is to continue the search for genes involved in Hirschsprung disease and to further characterize the known genes and the interactions between them. Our study will hopefully lead to a better understanding of the genetics of HSCR and, further down the road, improved diagnosis, treatment, and genetic counseling.
We ask study volunteers to:
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complete a medical/family history questionnaire
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provide access to some medical records
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submit blood (or cheek swab/saliva) samples from the individual(s) affected with Hirschsprung disease and his/her parents (if available)
If you are interested, a kit containing all the materials necessary to participate can be sent to you. There will be no cost to you.
For more information please contact the study coordinator, Courtney Nichols, at 410-502-7541 or hirschsprung@igm.jhmi.edu.
You can also visit our study website at: http://chakravarti.igm.jhmi.edu/pro_site/AravindaChakravartiLab/Hirschsprung_Study.html
Study of Hyperemesis Gravidarum
Hyperemesis gravidarum is severe nausea and vomiting of pregnancy requiring IV hydration and/or nutritional support. This is a study to identify epidemiologic and genetic factors involved in hyperemesis gravidarum.
There is no cost to participants or travel needed to participate in this study. Participants will be asked to:
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sign a consent form;
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answer a risk factor and outcomes survey;
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submit a saliva sample for DNA analysis; and
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identify an unaffected friend with at least 2 pregnancies that went beyond 27 weeks to participate in the study as a control.
If you have been diagnosed with hyperemesis gravidarum and you are interested in participating, please e-mail Dr. Marlena Fejzo at nvpstudy@usc.edu to determine eligibility.
This study is run by Dr. Marlena S. Fejzo and Dr. T. M. Goodwin at the University of Southern California, Los Angeles, is supported in part by the Intramural Research Program of the National Institute of Child Health and Human Development, National Institute of Health, Department of Health and Human Services, and has been approved by the USC Institutional Review Board HS-06-00056.The Clinical Center at the NIH in Bethesda, MD, is conducting a study on swallowing disorders. The purpose of these experimental studies is to compare two new ways of helping individuals with severe Dysphagia (swallowing disorders). Specifically to determine if surgical implantation of an intramuscular stimulation device, and/or if sensory stimulation can improve control and safety during of swallowing
The NIH will pay all study-related expenses. To qualify for a screening visit, a letter of referral and medical history information will need to be sent to the address below. Persons admitted to the study will have their expenses for travel to the NIH covered on future visits.
Individuals may qualify if they are 18-90 years of age, have chronic pharyngeal dysphagia (post six-months), have been instructed not to take food by mouth or are on a restricted diet, and have functional cognitive skills.
Individuals may not qualify if their neurological disorder is unstable; they have chronic obstructive pulmonary disorder (COPD); they are HIV positive or immune compromised; they are on a regular diet without difficulties; they have dementia, excessive somnolence, or agitation; or they have metal parts in the body such as prostheses, implants or shrapnel.
For more information, please contact Katie Burns at (301) 594-5193 or E-mail dietrichburnsk@ninds.nih.gov.
Participants Needed for Intestinal Pseudo-Obstruction Research Study
Boston University School of Medicine is conducting genetic research aimed at determining the gene(s) that are in some way involved or causally related to Intestinal Pseudo-Obstruction.If you or your child has a diagnosis of this as a primary diagnosis or part of another disease, and you are interested in participating, you can contact:
Mary Ann Whalen, M.S., C.G.C
Boston University School of Medicine, Center for Human Genetics
715 Albany St., W408
Boston, MA 02118
(617) 638-7170
maryann@bu.edu
More information on these studies may be available by calling (800) 776-OLEY.
Oley Foundation - North American Home Parenteral & Enteral Nutrition Patient Registry
Annual Report with outcome Profiles 1985-1992
If you are interested in having your study listed, complete this form (Research Form), OR fax the same information to (518) 262-5528.
Last updated: February 2010