NIH/Other Sponsored Clinical Trials and Studies

Clinical studies/trials are important in finding more and better treatments. Participation in clinical studies or trials offers one way to help advance GI research. Here is a list of clinical studies, in adults and children, that are seeking participants. A description of the study purpose and contact information is included.

Abdominal Pain 

Seattle, WA

Parents: Does your child or teen have frequent stomachaches?

Research at Children's Hospital Division of Gastroenterology (Seattle) and the University of Washington Children’s Hospital (Seattle) and the University of Washington are looking for volunteers to take part in a research study that looks at ways to help kids who have stomachaches with no known physical cause. If your child or teen age 8 to 16 years has stomach pain that interferes with daily activities, we want you to participate!

Both you and your child must take part in the study. To see if your child is eligible, we will ask you a few screening questions and discuss your child’s medical history over the phone. If eligible, you and your child will come to Children’s Hospital for three visits scheduled at times that work for you. At each hour-long visit, you and your child will talk to a counselor or social worker and learn ways to deal with stomachaches. No medicines are used in this study. You and your child will also be asked to complete a survey five times during the year. You will receive $30 for finishing each survey ($150 total by the end of the study).

The study, called the Recurrent Abdominal Pain (RAP) study, is funded by the National Institutes of Health and has been approved by Children’s Institutional Review Board. If you are interested in joining the study or would like to refer a child, please visit our website at www.rapstudy.org or call (206) 616-2358.

Seattle, WA

Research at Children's Hospital Division of Gastroenterology (Seattle) and the University of Washington

Volunteers from throughout the Puget Sound region are needed to take part in a research study. The study is looking at interventions to help children with Recurrent Abdominal Pain. We are studying children ages 8-16 who experience frequent stomachaches that interfere with their daily activities but have no known physical cause. We are asking both the child and parent to take part in this study.

The research involves a 10-minute telephone interview with the parent by the Project Director and examination of medical records by a Pediatric Gastroenterologist to see if the child is eligible. If eligible, the parent and child will attend three one-hour intervention sessions with a trained clinician at Children's Hospital over the course of two to three weeks. Visits will be arranged at times convenient to families.

At the visits, parent and child will learn information about coping with stomachaches. Parent and child will also be asked to complete questionnaires five times over the course of one year; these take approximately 60-90 minutes to fill out each time. Families will receive $30 for completing each set of questionnaires ($150 total by the end of the study).

The Principal Investigator for this project is Dr. Rona L. Levy, Professor, UW School of Social Work, (206) 543-5917. The study is funded by the National Institutes of Health and has been approved by Children's Hospital's Institutional Review Board (IRB). If you are interested in taking part in this research study or would like to refer a child to the study, please call the Project Director at (206) 616-2358. 

Chronic Intestinal Pseudo-Obstruction (CIP)

Boston, MA

Calling all Families: Genetic Study of Chronic Intestinal Pseudo-obstruction Syndrome

Researchers at the Center for Human Genetics at Boston University School of Medicine, headed by Aubrey Milunsky, M.D., D.Sc., are engaged in a study that aims to discover the gene(s) responsible for pseudo-obstruction. Dr. Milunsky is now requesting contact with families who have an affected child and at least one unaffected child. Researchers will be seeking a blood sample from both the affected and unaffected children and both parents. Studies are aimed at both neuropathic and myopathic forms of pseudo-obstruction.

Blood samples can easily be obtained anywhere in the nation or abroad and sent to the Center by Federal Express (next day delivery) for which the Center would cover the costs. The studies may eventually lead to the discovery of the gene and eventually more meaningful treatment. Families should contact either Dr. Aubrey, Jeff Milunsky, or MaryAnn Whalen, M.S. by telephone (617-638-7083), by fax (617-638-7092), or by email (amilunsk@bu.edu).

Aubrey Milunsky, M.D., D.Sc.
Director, Center for Human Genetics
Boston University School of Medicine
715 Albany Street
Boston, MA 02118-2526

_{Verified April 2011} 

Cyclic Vomiting Syndrome (CVS)

Internet/Online

A research study is being conducted by Richard G. Boles, M.D. from the Department of Medical Genetics at CHLA in order to learn what the experiences are regarding two nutritional supplements, co-enzyme Q10 (also known as "Co-Q") and L-carnitine (Carnitor), and one medication, amitriptyline (Elavil), for the treatment of cyclic vomiting syndrome (CVS). Find out more and access online survey here.

The Cyclic Vomiting Syndrome Association (CVSA) is undertaking a formal process of educating Emergency Room physicians and para-professionals about Cyclic Vomiting Syndrome (CVS). They are asking for your participation in a brief survey via this link in order to help plan this educational approach, which is under the project leadership of  B.U.K. Li, M.D., Children's Hospital of WI. 

_{Verified April 2011}

Milwaukee, WI

Autonomic dysfunction in adults with Cyclic Vomiting Syndrome (CVS)

Subjects are currently being recruited for participation in study at the Medical College of Wisconsin to start around December 2007. The aim of the study is to prospectively evaluate the presence of autonomic dysfunction in patients with CVS. Studies will take place in Milwaukee, Wisconsin.

Criteria for participation

Adults who meet the following three criteria and had episodes at least 6 months before they were diagnosed:

1. Episodes that are similar in when they start and how long they last.

2. Three or more discrete episodes in the prior year

3. Absence of nausea and vomiting between episodes

In addition, all subjects will have had the necessary work up to exclude other organic diseases resulting in cyclic vomiting. 

Exclusion criteria
Exclusion criteria include the presence of other diseases that affect autonomic testing (e.g., any chronic pain disorder, or endocrinological, cardiovascular or other neurological diseases).

If you are interested, please contact:

Thangam Venkatesan, MD
Medical College of Wisconsin
Division of Gastroenterology
(414) 456-6836
Email: kcieszk@mcw.edu

Gastroparesis

NIH Gastroparesis Clinical Research Consortium  (GpCRC)

The GpCRC is recruiting patients for their gastroparesis registry. Individuals with gastroparesis who sign up for the registry may be contacted about participating in trials or surveys about gastroparesis. The GpCRC is a network of medical centers, sponsored by the National Institutes of Health (NIH), Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), established to improve our understanding of the cause and natural course of gastroparesis and to advance the diagnosis and treatment of this disorder.

Gainesville, FL

A study at the University of Florida is looking at the comparative effectiveness of two drugs, Azithromycin (AZI) and Erythromycin in the treatment of gastroparesis. The effectiveness of Erythromycin is currently known in the treatment of gastroparesis patients, however in susceptible patients is associated with adverse events. Azithromycin is an antibiotic with fewer known side effects.

The study is open to men and women aged 18 to 65 presenting to gastroenterology motility specialty clinics at the University of Florida, who meet the clinical and radiologic diagnostic criteria for diagnosis of gastroparesis.

Contact

Lasheaka V. McClellan at 352-392-6293; lasheaka.mcclellan@medicine.ufl.edu

Cheryl Curington, BS at 352-392-6293; cheryl.curington@medicine.ufl.edu 

_{ctg September 2011}

Jackson, MI

Allegiance Health Gastroenterology in Jackson Michigan is conducting a study to determine whether the drug, domperidone, can be used safely and effectively for patients with gastroparesis.

Men and women aged 18 and over who have been diagnosed with gastroparesis and have failed at least one standard therapy will be offered to trial domperidone as a possible remedy to their condition. Patients on the medication will be expected to be followed by the physician at 3 months, 6 months 12months, and then annually while on the medication. Any change or significant adverse reaction to the medication or in their condition should be reported immediately to their physician.

Contact

John Sturtevant, RN, MSN at 517-841-1409; john.sturtevant@allegiancehealth.org

_{ctg September 2011}

GI Symptoms

Online

The University of Florida, Colleges of Nursing and Pharmacy, is conducting an anonymous online survey (UF IRB approval #2012-U-1269) on GI symptoms and the use of herbal supplements for relieving such symptoms. The survey is completely anonymous and will take approximately 25 minutes to complete. The survey is intended to provide researchers with important information about the use of herbal supplements by patients with GI symptoms. Please click on the link below to start the survey. Thank you for your help. [Link to survey]

Hirschsprung's Disease

Baltimore, MD

Dr. Aravinda Chakravarti’s laboratory at Johns Hopkins University has been investigating the genetics of Hirschsprung disease for more than twenty 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 Hirschsprung disease and, further down the road, improved diagnosis, treatment, and genetic counseling.

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.

Anyone with Hirschsprung disease and their family members may join the study. We ask study volunteers to complete a medical/family history questionnaire, provide access to some medical records, and to 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 Berrios, at 410-502-7541 or hirschsprung@igm.jhmi.edu.

You can also visit our study website at: https://aravindachakravartilab.org/pro/Hirschsprung_Study.html.

_{Updated Feb 2012}

 

Irritable Bowel Syndrome (IBS)

Chapel Hill, NC

Genetic and environmental factors that cause or influence IBS – University of North Carolina Functional GI & Motility Disorders Center

This study involves measuring the relationship between genes, the environment, and various psychological and health factors in men and women with IBS. Individuals who participate will spend one overnight visit in the General Clinical Research Center at UNC Hospital. No additional visits required.

Contact: Lenore Keck, RN
Phone: 919-966-8329 
Principal Investigator: William E. Whitehead, PhD

Requirements
To participate in this study, you must be 18 years or older and diagnosed with Irritable Bowel Syndrome by a physician.

Compensation
Participants completing the study will receive $250-$300.
We also need healthy control subjects without any symptoms of IBS.  One visit (no overnight visit required). $50

Please visit www.uncmedresearch.com/ibsstudy or call toll-free 1-866-227-0067.

Chapel Hill, NC 

Healthy Controls Needed for Research Study

We are conducting a research study investigating a broad range of factors that may cause or influence IBS. We are looking for subjects without IBS or any other gastrointestinal (stomach or bowel) symptoms to participate.

Contact: Research Nurse, Lenore Keck, RN, (919) 966.8329, akeck@med.unc.edu 

Participation

• Must be 18 years or older.
• Must have not experienced any gastrointestinal symptoms within the last 3 months.
• Must fill out various health questionnaires & physiological testing
• Involves one 4 hour visit to the Clinical and Translational Research Center at UNC Hospital.

For more information on how to sign up please visit: Please visit www.uncmedresearch.com/ibsstudy or call toll-free 1-866-227-0067. 

Chicago, IL

Center for Psychosocial Research in GI, Feinberg School of Medicine, Northwestern University, Chicago IL is seeking volunteers for an Irritable Bowel Syndrome Outcome Study (IBSOS).

The Irritable Bowel Syndrome Outcome Study (IBSOS) is a seven-year, multi-site clinical trial to test the efficacy of a behavioral self-management treatment for irritable bowel syndrome (IBS) funded by the NIH. The long-term goal of the project is to develop an effective, self-administered behavioral treatment program that can enhance the quality of patient care, improve clinical outcomes, and decrease the economic and personal costs of one of the most prevalent and intractable GI disorders.

This is a multi-center study involving 480 subjects, with 240 subjects participating here at Northwestern University and 240 subjects participating at the University of Buffalo.

Study participants are assigned to 1 of 3 non-drug treatment groups. One group will undergo treatment that will involve 10 weekly clinic visits, while the other 2 groups will undergo treatment with 4 clinic visits and 2 brief telephone calls over the same 10 week period. There follow-up period consisting of 5 visits over the year following treatment.

Contact:
IBSOS Study Coordinator, Phone: 312-695-6729
E-mail: IBSOS@northwestern.edu
Website: www.cprgi.org

_{Updated February 2012}

Internet/Online 

IBS survey: Defining the Clinical Features and Prognosis of Post Infectious and other IBS groups.

The European Gastroenterology Federation is undertaking a survey of patients with irritable bowel syndrome. This is a web based survey designed to help learn more about irritable bowel syndrome in order that physicians might better plan treatments and management. Of particular interest is how symptoms develop over time. The study is multilingual and is currently available in nine languages. To participate, go to www.postinfectious-ibs.eu and click on your language of choice to complete the simple online questionnaire.

_{Updated April 2011}

Top of Page

Los Angeles, CA

Therapeutic Movement as a Complementary Treatment for Irritable Bowel Syndrome (IBS) - UCLA

Participate in a UCLA research study of the benefits of Therapeutic Movement (Therapeutic Yoga & Therapeutic Walking) for Irritable Bowel Syndrome (IBS).

You must be between 18 and 65 years of age and living in the Los Angeles area. If eligible, you will be able to attend 16 Movement Classes, free of charge.

Groups will be held at UCLA on weekday evenings and weekend afternoons. Each session will be around 1 hour in length. The study will offer 16 sessions of their yoga or walking program as a part of participation in the study. The aim is to evaluate if these programs assist with the symptoms of IBS. 

Contact: Phone 310-825-6475 for more information.

Study conducted by David Shapiro, PhD, and Bruce Naliboff, PhD, UCLA Department of Psychiatry. 

_{Added August 2011}

New York, NY

IBS: Attachment style, catastrophizing and negative pain beliefs

This is an international study of IBS patients in ten different sites around the globe. It is directed by the Mind-Body Digestive Center in New York City. Patients are asked to complete a set of four questionnaires at the time of their initial visit, recorded anonymously without any patient identification.

The goal of this study is to see if there are any universal patterns, or any intra-country differences in the way that the psycho-social measures above correlate with the severity of symptoms in IBS patients.

Contact: The Mind-Body Digestive Center, directed by Charles Gerson, M.D. and Mary-Jane Gerson, Ph.D.
Telephone: 212-712-0494, Fax: 212-787-0983

_{Added April 2011}

Piscataway, NJ

Study on Treatment of Fibromyalgia, Irritable Bowel Syndrome, Chronic Fatigue Syndrome, TMJ, or Chemical Sensitivities

Are you bothered by multiple, persistent physical symptoms, (such as pain, fatigue, gastrointestinal difficulties or menstrual difficulties)?

Do you have Fibromyalgia, Irritable Bowel Syndrome, Chronic Fatigue Syndrome, TMJ, or Chemical Sensitivities?

You may be eligible for a free treatment study.

Dr. Lesley Allen is studying a new psychosocial treatment designed to help reduce physical discomfort.

Participants must be 18-65 years of age and have multiple, unexplained physical symptoms.

For more information, call Dr. Lesley Allen at:

Robert Wood Johnson Medical School
671 Hoes Lane, Piscataway, NJ
732-235-4412/3378

For more information about this study, visit http://www.clinicaltrials.gov. The National Institutes of Health is part of the Department of Health and Human Services. (Posted 10/14/2005)

Short Bowel Syndrome

Boston, MA

A study at Children's Hospital Boston is looking at whether the omega-3 fatty acid emulsion (Omegaven), when used instead of conventional soy-based fat emulsion, is effective in the treatment of parenteral nutrition associated liver disease (PNALD).

Patients up to 17 years old are eligible to be considered for the study based on criteria such as being PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least another 30 days, and have parenteral nutrition associated liver disease (PNALD), among other criteria.

For details contact

Mark Puder, MD, PhD; mark.pude@childrens.harvard.edu

Kathleen Gura, PharmD; kathleen.gura@chilcrens.harvard.edu

_{ctg September 2011} 

Little Rock, AR

Researchers at Arkansas Children's Hospital Research Institute are conducting a study is to evaluate the many effects of fiber added in the diet of infants with short bowel syndrome. Infants with short bowel syndrome suffer from diarrhea and poor growth, and care is limited by the lack of effective therapies. Soluble fiber (guar gum) is an indigestible form of sugar that is mostly contained in fruits and vegetables. Soluble fiber can reduce the severity and duration of constant diarrhea in children.

Eligibility

The study is open to infants less than 1 year of age who

• Have Short Bowel Syndrome defined by a history of congenital or surgical loss of intestinal absorptive function resulting in parenteral nutrition dependency of longer than 30 days;
• Are receiving at least 20% of their caloric needs from enteral nutrition and have been on enteral nutrition for at least 1 week following intestinal resection;
• Have increased stool output as manifested by watery stools (3-12/day) and increased ostomy output (20-50 cc/kg/day);
• Have not received antibiotics, probiotics or prebiotics for 2 weeks prior to study entry. 

Contact Juliana Frem, MD at 501-364-1004; fremjulianac@uams.edu

Sphincter of Oddi Dysfunction

Baltimore, MD

Johns Hopkins Hospital is seeking participants for a clinical study.

The sphincter of Oddi is a muscular valve that controls the flow of digestive juices (bile and pancreatic juice) into the first part of the small intestine (duodenum). "Sphincter of Oddi dysfunction (SOD)" describes the situation when the sphincter does not relax at the appropriate time (due to scarring or spasm). The back-up of juices causes episodes of severe abdominal pain. The diagnosis is often considered in patients who present with recurrent attacks of pain after surgical removal of the gall bladder (cholecystectomy), and in some who suffer from recurrent attacks of unexplained pancreatitis.

Uncertainties in how best to diagnose and to treat suspected sphincter of Oddi dysfunction (and the risks involved) mandate further scientific investigation. Treatment often involves an endoscopic procedure called ERCP, which carries a significant risk of complications. It must be done under sedation by experts trained in the technique. The National Institutes of Health has recently funded an important study called "EPISOD" in 6 major Gastroenterology centers in USA.

Essentially, patients with burdensome pains after cholecystectomy who fulfill the Rome III criteria for sphincter of Oddi dysfunction undergo extensive evaluation for functional and psychiatric disorders. Those who consent to the study undergo ERCP along with another test called Sphincter of Oddi manometry (SOM), and are randomized to biliary and/or pancreatic sphincterotomy (cutting the sphincter to remove any stones or to relieve any scarring or spasm), or to a sham procedure, regardless of the manometry findings. Their clinical course is monitored for up to 4 years. Details are available on the NIH website at www.clinicaltrials.gov

Contact:
Laurie McClelland, BNS, RN, phone: 410-955-3822 or email: lam@jhmi.edu

Birmingham, AL

The University of Alabama at Birmingham is seeking participants for a clinical study.

The sphincter of Oddi is a muscular valve that controls the flow of digestive juices (bile and pancreatic juice) into the first part of the small intestine (duodenum). "Sphincter of Oddi dysfunction (SOD)" describes the situation when the sphincter does not relax at the appropriate time (due to scarring or spasm). The back-up of juices causes episodes of severe abdominal pain. The diagnosis is often considered in patients who present with recurrent attacks of pain after surgical removal of the gall bladder (cholecystectomy), and in some who suffer from recurrent attacks of unexplained pancreatitis.

Uncertainties in how best to diagnose and to treat suspected sphincter of Oddi dysfunction (and the risks involved) mandate further scientific investigation. Treatment often involves an endoscopic procedure called ERCP, which carries a significant risk of complications. It must be done under sedation by experts trained in the technique. The National Institutes of Health has recently funded an important study called "EPISOD"  in 6 major Gastroenterology centers in USA.

Essentially, patients with burdensome pains after cholecystectomy who fulfill the Rome III criteria for sphincter of Oddi dysfunction undergo extensive evaluation for functional and psychiatric disorders. Those who consent to the study undergo ERCP along with another test called Sphincter of Oddi manometry (SOM), and are randomized to biliary and/or pancreatic sphincterotomy (cutting the sphincter to remove any stones or to relieve any scarring or spasm), or to a sham procedure, regardless of the manometry findings. Their clinical course is monitored for up to 4 years. Details are available on the NIH website at www.clinicaltrials.gov

Contact:
Toni Seay, phone: 205-934-7332 or email: tamartin@uab.edu

Charleston, SC

The Medical University of South Carolina Digestive Disease Center is seeking participants for a clinical study.

The sphincter of Oddi is a muscular valve that controls the flow of digestive juices (bile and pancreatic juice) into the first part of the small intestine (duodenum). "Sphincter of Oddi dysfunction (SOD)" describes the situation when the sphincter does not relax at the appropriate time (due to scarring or spasm). The back-up of juices causes episodes of severe abdominal pain. The diagnosis is often considered in patients who present with recurrent attacks of pain after surgical removal of the gall bladder (cholecystectomy), and in some who suffer from recurrent attacks of unexplained pancreatitis.

Uncertainties in how best to diagnose and to treat suspected sphincter of Oddi dysfunction (and the risks involved) mandate further scientific investigation. Treatment often involves an endoscopic procedure called ERCP, which carries a significant risk of complications. It must be done under sedation by experts trained in the technique. The National Institutes of Health has recently funded an important study called "EPISOD" in 6 major Gastroenterology centers in USA.

Essentially, patients with burdensome pains after cholecystectomy who fulfill the Rome III criteria for sphincter of Oddi dysfunction undergo extensive evaluation for functional and psychiatric disorders. Those who consent to the study undergo ERCP along with another test called Sphincter of Oddi manometry (SOM), and are randomized to biliary and/or pancreatic sphincterotomy (cutting the sphincter to remove any stones or to relieve any scarring or spasm), or to a sham procedure, regardless of the manometry findings. Their clinical course is monitored for up to 4 years. Details are available on the NIH website at www.clinicaltrials.gov

Contact:
April Williams, CCRC, phone: (843) 876-7234 or email: woodap@musc.edu

_{Verified April 2011}

Indianapolis, IN

Indiana University is seeking participants for a clinical study.

The sphincter of Oddi is a muscular valve that controls the flow of digestive juices (bile and pancreatic juice) into the first part of the small intestine (duodenum). "Sphincter of Oddi dysfunction (SOD)" describes the situation when the sphincter does not relax at the appropriate time (due to scarring or spasm). The back-up of juices causes episodes of severe abdominal pain. The diagnosis is often considered in patients who present with recurrent attacks of pain after surgical removal of the gall bladder (cholecystectomy), and in some who suffer from recurrent attacks of unexplained pancreatitis.

Uncertainties in how best to diagnose and to treat suspected sphincter of Oddi dysfunction (and the risks involved) mandate further scientific investigation. Treatment often involves an endoscopic procedure called ERCP, which carries a significant risk of complications. It must be done under sedation by experts trained in the technique. The National Institutes of Health has recently funded an important study called "EPISOD" in 6 major Gastroenterology centers in USA.

Essentially, patients with burdensome pains after cholecystectomy who fulfill the Rome III criteria for sphincter of Oddi dysfunction undergo extensive evaluation for functional and psychiatric disorders. Those who consent to the study undergo ERCP along with another test called Sphincter of Oddi manometry (SOM), and are randomized to biliary and/or pancreatic sphincterotomy (cutting the sphincter to remove any stones or to relieve any scarring or spasm), or to a sham procedure, regardless of the manometry findings. Their clinical course is monitored for up to 4 years. Details are available on the NIH website at www.clinicaltrials.gov

Contact:
Laura Lazzell-Pannell, BSN, RN, phone: 317-278-3119 or email: llazzell@iupui.edu
Suzette Schmidt, BSN, RN, phone: 317-278-8104 or email: suschmid@iupui.edu

_{Verified April 2011}

Minneapolis, MN

The Hennepin County Medical Center is seeking participants for a clinical study.

The sphincter of Oddi is a muscular valve that controls the flow of digestive juices (bile and pancreatic juice) into the first part of the small intestine (duodenum). "Sphincter of Oddi dysfunction (SOD)" describes the situation when the sphincter does not relax at the appropriate time (due to scarring or spasm). The back-up of juices causes episodes of severe abdominal pain. The diagnosis is often considered in patients who present with recurrent attacks of pain after surgical removal of the gall bladder (cholecystectomy), and in some who suffer from recurrent attacks of unexplained pancreatitis.

Uncertainties in how best to diagnose and to treat suspected sphincter of Oddi dysfunction (and the risks involved) mandate further scientific investigation. Treatment often involves an endoscopic procedure called ERCP, which carries a significant risk of complications. It must be done under sedation by experts trained in the technique. The National Institutes of Health has recently funded an important study called "EPISOD" in 6 major Gastroenterology centers in USA.

Essentially, patients with burdensome pains after cholecystectomy who fulfill the Rome III criteria for sphincter of Oddi dysfunction undergo extensive evaluation for functional and psychiatric disorders. Those who consent to the study undergo ERCP along with another test called Sphincter of Oddi manometry (SOM), and are randomized to biliary and/or pancreatic sphincterotomy (cutting the sphincter to remove any stones or to relieve any scarring or spasm), or to a sham procedure, regardless of the manometry findings. Their clinical course is monitored for up to 4 years. Details are available on the NIH website at www.clinicaltrials.gov

Contact:
Phil Lacher, phone: 612-341-7900

Seattle, WA

The Virginia Mason Medical Center is seeking participants for a clinical study.

The sphincter of Oddi is a muscular valve that controls the flow of digestive juices (bile and pancreatic juice) into the first part of the small intestine (duodenum). "Sphincter of Oddi dysfunction (SOD)" describes the situation when the sphincter does not relax at the appropriate time (due to scarring or spasm). The back-up of juices causes episodes of severe abdominal pain. The diagnosis is often considered in patients who present with recurrent attacks of pain after surgical removal of the gall bladder (cholecystectomy), and in some who suffer from recurrent attacks of unexplained pancreatitis.

Uncertainties in how best to diagnose and to treat suspected sphincter of Oddi dysfunction (and the risks involved) mandate further scientific investigation. Treatment often involves an endoscopic procedure called ERCP, which carries a significant risk of complications. It must be done under sedation by experts trained in the technique. The National Institutes of Health has recently funded an important study called "EPISOD" in 6 major Gastroenterology centers in USA.

Essentially, patients with burdensome pains after cholecystectomy who fulfill the Rome III criteria for sphincter of Oddi dysfunction undergo extensive evaluation for functional and psychiatric disorders. Those who consent to the study undergo ERCP along with another test called Sphincter of Oddi manometry (SOM), and are randomized to biliary and/or pancreatic sphincterotomy (cutting the sphincter to remove any stones or to relieve any scarring or spasm), or to a sham procedure, regardless of the manometry findings. Their clinical course is monitored for up to 4 years. Details are available on the NIH website at www.clinicaltrials.gov

Contact:
Alice Stead, phone: 206-341-1450

_{Verified April 2011}