NIH/Other Sponsored Clinical Trials and Studies

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.

Baltimore, MD

Hirschsprung Disease: Participants Sought for Genetic Study

Our laboratory at Johns Hopkins University is seeking participants for an ongoing study of the genetic basis of Hirschsprung disease.

We are studying how changes in the DNA sequence of one or more genes can lead to Hirschsprung disease, how these genes interact, and how they are passed through generations. At least 8 genes have already been implicated in the development of Hirschsprung disease (HSCR), and we are searching for changes in additional, still unidentified, genes. Finally, we are trying to identify genetic factors that may modify a person's risk to develop HSCR. 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 complete a medical/family history questionnaire, and to submit blood samples from the individual(s) affected with Hirschsprung disease and his/her parents. Siblings of the individual(s) with Hirschsprung disease are also helpful if available. In the laboratory, we extract DNA from the blood samples and use a variety of methods to study the individuals' DNA sequence. Participants will be mailed a blood collection kit, which also includes the questionnaire and consent forms. Please note that we will reimburse you and your family members for any costs associated with having your blood drawn.

Thank you for your interest-you make our work possible.

For more information about the genetics of Hirschsprung disease, or to participate in our research study, please visit our website.

Or Contact:

Julie (Albertus) Muskett, M.S.
Genetic Counselor and Study Coordinator
Phone: (410) 502-7541
E-mail: hirschsprung@igm.jhmi.edu

Aravinda Chakravarti, PhD
Professor and Director
McKusick-Nathans Institute of Genetic Medicine
Johns Hopkins Hospital
733 N. Broadway, Room 543
Baltimore, MD 21205
E-mail: aravinda@jhmi.edu

Bethesda, MD

Eosinophilic Gastroenteritis Treatment Study

Doctors at the National Institutes of Health (NIH) are conducting a study testing a potential new treatment for eosinophilic gastroenteritis (EG). This study is evaluating the safety and effectiveness of omalizumab (Xolair(tm)) in decreasing the amount of eosinophils in the blood, which may reduce the symptoms of EG. If you have EG and are ages 12 to 76, please consider participating in this study. All study-related tests and medications are provided at no cost. Travel and lodging reimbursement is available. To participate, contact 1-800-411-1222 (TTY#: 1-866-411-1010).

Se habla español. For more information about this study, visit http://clinicaltrials.gov. The National Institutes of Health is part of the Department of Health and Human Services. (Posted 9/1/2005)

Boston, MA

Research Study -- Do you have IBS?

Boston Medical Center is seeking volunteers in the Boston area to take part in a research study about Patient Education in Irritable Bowel Syndrome

The study involves one visit and filling in questionnaires. The compensation for the study is $10 - $25.

To learn more about the study contact the study coordinator, Abha Verma, at Phone: 1-617-638-6579 or Email: abha.verma@bmc.org. (Posted 2/7/2006)

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

Chapel Hill, NC

University of North Carolina Functional GI & Motility Disorders Center Clinical Study

The University of North Carolina Functional GI & Motility Disorders Center is beginning a series of innovative treatment trials for individuals with irritable bowel syndrome. Some trials involve new pharmaceutical agents, and others involve behavioral interventions (e.g., hypnosis, cognitive behavioral treatment).

These trials are funded either by pharmaceutical companies or the National Institutes of Health. In all cases, the trials are at no expense, and may involve a free medical evaluation. In some cases, subjects are paid for their time. All studies are approved by the University Institutional Human Rights Committee.

If you are interested and are able to visit the Chapel Hill, North Carolina area, please write c/o Division of Digestive Diseases, University of North Carolina, 420 Burnett-Womak CB #7080, Chapel Hill, N.C., 27599-7080. They will forward to you a screening questionnaire to determine eligibility for their studies and (if you agree) place you on their mailing list for future studies.

Chicago, IL

Northwestern Center for Functional Gastrointestinal & Motility Disorders, Chicago IL is seeking volunteers for 3 studies:

Study #1:

Assessment of Psychosocial Factors in Patients with Inflammatory Bowel Disease, Functional Digestive Disorders and Healthy Controls

The purpose of the study is to evaluate a variety of psychosocial characteristics in patients with inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), and healthy individuals. The diagnosis of IBS is one of the most common diagnoses made by gastroenterologists (doctors who specialize in stomach and intestinal function). IBS is a disorder of the brain-gut function which can lead to severe impairments of gastrointestinal function. The diagnosis of IBD is less common, but many of the symptoms that IBD patients experience are similar to patients with IBS. This study will involve completing 8 online questionnaires, and should take you approximately 30 minutes to complete.

Contact:
Jason Bratten, Phone: 312-695-2742
E-mail: j-bratten@northwestern.edu
Website: www.northwesternmotility.com/studylogin.html#generalqs

Study #2:

Functional Dyspepsia Treatment Trial

The purpose of this study is to investigate if two FDA approved antidepressant medicines are more effective medicines than placebo (sugar pill) in treating dyspepsia. This study will also determine if gastric (stomach) emptying test and nutrient drink test, two tests that measure stomach function, are changed by the treatment of these study medicines. Compensation for participation is provided. This is a multi-center study involving 400 subjects. The total time to complete the study is approximately 9 months and involving 12 visits.

Contact:
Jason Bratten, Phone: 312-695-2742
E-mail: j-bratten@northwestern.edu
Website: www.northwesternmotility.com/recruit.html

Study #3:

Evaluation of Duodenal Acid Exposure in Healthy Controls and Patients with Nonulcer Dyspepsia Using a Radiotelemetry pH Monitoring System

This study uses a radiotelemetry pH monitoring system to evaluate duodenal (small intestine) acid exposure (pH levels) in healthy subjects and patients with symptoms of non-ulcer dyspepsia. Duodenal acidification has been associated with symptom development in patients with non-ulcer dyspepsia. Compensation for participation is provided. The total time to complete the study is approximately 6 weeks.

Contact:
Jason Bratten, Phone: 312-695-2742
E-mail: j-bratten@northwestern.edu
Website: www.northwesternmotility.com/recruit.html

Internet/Online

Irritable Bowel Syndrome (IBS) 

Do you have IBS? Boston University School of Medicine is doing an online study about writing and irritable bowel syndrome. The purpose of our study is to research the effects of writing on the management of irritable bowel syndrome. The entire study is completed online and involves:

•  Writing for 30 minutes/day for four consecutive days 

•  Completing several questionnaires before and after the writing
    phase of the study

 

The compensation for participating in the study is $25. At this time we can only enroll US residents. To participate in the study please visit www.bmc.org/ibs.

To learn more about the study please contact us at 617-638-6579 or email at ibs.study@bmc.org.  

 

Cyclic Vomiting Syndrome (CVS)

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. 

 

Participate online in a survey designed to help assess upper and lower gastrointestinal symptoms and health-related quality of life.

The website was developed, and the data collected will be used academically, by Professor Paul Enck PhD, Director of Research, Department of Internal Medicine VI/Psychosomatic Medicine and Psychotherapy at University Hospitals in Tübingen, Germany. Dr. Enck is an international member of the Advisory Board of IFFGD.

This is the first interactive Rome II Questionnaire for irritable bowel syndrome (IBS) in English; a German version can be found on www.gesundheits-umfrage.de, and a Spanish version is in preparation. Patients answering this questionnaire will be provided a statement of how their symptoms might fit into the Rome II classification of functional bowel disorders, as well as how symptoms affect the quality of life. The website is hosted by Holburn Clinical Trial Corporation, a contract research organization. To participate, go to the questionnaire »

Jacksonville, FL

Functional Dyspepsia Treatment Trial - Mayo Clinic Jacksonville 

 

This study is being done for people with upper abdominal discomfort or pain, early fullness after eating, nausea and/or upper abdominal bloating.

We propose to investigate whether antidepressant medications are efficacious in functional dyspepsia. The prescription of antidepressants to treat functional dyspepsia is based on three propositions. First, antidepressants could reduce the severity of co-morbid psychological symptoms, especially anxiety and depression. Second, antidepressants have central analgesic actions. Thirdly, antidepressants have been shown to have local pharmacological actions on the gut, and may specifically alter gastric emptying and fundic relaxation based on preliminary data, but the relevance of such perturbations to treatment outcome is not established.

The total time to complete the study will be 9 months, including 12 weeks on study medication, and 6 months follow up phase.

Contact:
Verna Skinner, 904-953-2000, Ext 78-3-2255
E-mail: skinner.verna@mayo.edu  
Mayo Clinic
Jacksonville, FL 32224 

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 Gas troenterology
(414) 456-6836
Email: kcieszk@mcw.edu

 New York, NY

Controlled Research Study of IBS Treatment - The Mind-Body Digestive Center, NY, NY

The basis for the study is the documented effectiveness of short-term psychological treatment in patients with ongoing IBS that does not respond to usual gastroenterological measures. The treatment model is unique and may advance the understanding of how to treat patients with IBS.

This research project is interested in two facets of IBS treatment that reflects its connection between brain and gut. One is a collaborative approach where both gastroenterologist and psychologist see the patient together, and the other is the effect of intimate relationships with others on the patient with IBS.

The study will have three study arms, (1) GI treatment plus collaboration between gastroenterologist and psychologist as above. (2) GI treatment plus short-term psychotherapy. (3) gastroenterological treatment alone. All three groups will receive relaxation training. Family members or significant others will be included when possible.

The Mind-Body Digestive Center, directed by Charles Gerson, M.D. and Mary-Jane Gerson, Ph.D. Telephone: 212-712-0494, Fax: 212-878-0983

Charles Gerson, M.D. And Mary-Jane Gerson, Ph.D. are gastroenterologist/clinical psychologist team conducting a controlled research study of IBS treatment. The project has been approved by the Mt. Sinai School of Medicine Institutional Review Board.

Outcome Research Study of Group Hypnotherapy Program - The Mind-Body Digestive Center, NY, NY

Hypnotherapy has been shown to be beneficial to patients with Irritable Bowel Syndrome in well conducted research studies at four academic centers. Approximately two out of every three patients have shown significant improvement from this treatment.

In this study, IBS patients who have entered a group hypnotherapy program will be asked to fill out a series of questionnaires prior to the outset of treatment. Questionnaires will also be administered after the last session and at subsequent intervals. The goal of the study is to determine whether it is possible to predict positive outcome of treatment (which type of patient will respond), based on pre-treatment patient characteristics.

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.

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)?

-OR-

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://clinicaltrials.gov. The National Institutes of Health is part of the Department of Health and Human Services. (Posted 10/14/2005)

Rochester, MN

Functional Dyspepsia Treatment Trial - Mayo Clinic Rochester 

 

This study is being done for people with upper abdominal discomfort or pain, early fullness after eating, nausea and/or upper abdominal bloating.

We propose to investigate whether antidepressant medications are efficacious in functional dyspepsia. The prescription of antidepressants to treat functional dyspepsia is based on three propositions. First, antidepressants could reduce the severity of co-morbid psychological symptoms, especially anxiety and depression. Second, antidepressants have central analgesic actions. Thirdly, antidepressants have been shown to have local pharmacological actions on the gut, and may specifically alter gastric emptying and fundic relaxation based on preliminary data, but the relevance of such perturbations to treatment outcome is not established.

The total time to complete the study will be 9 months, including 12 weeks on study medication, and 6 months follow up phase.

Contact:
Vickie M. Silvernail, L.P.N., S.C., 507-284-2511, Ext. 2812
E-mail: silvernail.vickie@mayo.edu 
Group E-mail: dyspepsia@mayo.edu 
Mayo Clinic
Rochester, MN 55905 

Scottsdale, AZ

Functional Dyspepsia Treatment Trial - Mayo Clinic Scottsdale 

This study is being done for people with upper abdominal discomfort or pain, early fullness after eating, nausea and/or upper abdominal bloating.

We propose to investigate whether antidepressant medications are efficacious in functional dyspepsia. The prescription of antidepressants to treat functional dyspepsia is based on three propositions. First, antidepressants could reduce the severity of co-morbid psychological symptoms, especially anxiety and depression. Second, antidepressants have central analgesic actions. Thirdly, antidepressants have been shown to have local pharmacological actions on the gut, and may specifically alter gastric emptying and fundic relaxation based on preliminary data, but the relevance of such perturbations to treatment outcome is not established.

The total time to complete the study will be 9 months, including 12 weeks on study medication, and 6 months follow up phase.

Contact:
Group E-mail: dyspepsia@mayo.edu 
Mayo Clinic
Scottsdale, AZ 85259

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.

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.