Research Study at OSU

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Dear Friend of ASO:

Information on a research study at Ohio State. FYI - please share.

Sincerely,

Barbara C. YavorcikPresidentAutism Society of Ohio701 S. Main St.Akron, OH 44311(330) 376-0211fax: (330) 376-1226email: askASO@...home: byavorcik@...web: www.autismohio.org2005 ASO Bi-Annual Conference"Reaching Beyond the Horizon - Challenging the Autism Spectrum"Friday and Saturday, October 14-15, 2005 Kingsgate Marriott in Cincinnati, Ohio Please note: This is provided for information purposes only. The ASO does not endorse or recommend any providers, methodologies or services. Providing this information should not be construed as an endorsement by the ASO, either explicit or impiled.

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WIRB Protocol No. 20050374

Ohio State University

(Nisonger Center)

is currently recruiting participants for a

RESEARCH STUDY OF A MEDICATION FOR GASTROINTESTINAL PROBLEMS IN

CHILDREN with AUTISM

This 4 ½ month study is designed to examine the safety and effectiveness of an investigational medication in children with autism and stomach or bowel problems. The study will be using a combination of placebo (fake medication) or study drug for 4½ months (random assignment).

To be eligible for this study, participants must:

· be between the ages of 2 and 17 years, inclusive,

· meet diagnostic criteria for autism,

· experience regular stomach or bowel problems (chronic diarrhea or constipation, bloating, gas, abdominal pain)

· not have a significant medical condition (e.g. heart disease, liver or kidney failure, unstable seizure disorder),

· have no plans for medication changes in the next 4½ months

ALL EVALUATIONS AND MEDICATION FOR THIS STUDY ARE PROVIDED WITHOUT COST TO PARTICIPANTS. iN ADDITION, Families who participate Will be reimbursed. there are risks, which will be explained before anyone agrees to participate.

Contact Person:

Crowl Phone: (614) 688-8214

Fax: (614) 688-4908

E-mail: crowl.15@...

Principal Investigator: Aman, Ph.D.

Co-Investigators: Eugene Arnold, M.D., Yaser Ramadan, M.D.

Project Coordinator: Crowl

Associate Project Coordinator: Amy Cook

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“Stomach Medicine†Being Tested in Children with Autism

Researchers at Ohio State University Nisonger Center are working with a pharmaceutical company to test the safety and effectiveness of an investigational drug known as Oralgam. Oralgam, or oral human immunoglobulin, is a natural product that contains human antibodies. Antibodies are particles that the body forms to fight illnesses. Examples of these illnesses include measles, chickenpox, flu, and colds. These antibodies also help fight infections in the stomach and intestines. As many as 25% to 40% of children with autism experience regular stomach problems, including chronic diarrhea or constipation, bloating, gas, or abdominal pain. It is possible that the stomach problems may lead to behavior difficulties in such children. The O.S.U. investigators are also hoping that the investigational medication may improve problem behaviors in these youngsters.

Investigators at O.S.U. are looking for participants to be in the present research study. To be eligible for the study, the child must be between the ages of 2-17 years, satisfy criteria for autism (not Asperger’s Disorder or PDD-NOS), and have a history of chronic constipation or diarrhea, and abnormal gaseousness or abdominal pain.

The study takes 4 ½ months for each participant. There is a 75% chance of receiving Oralgam, and a 25% chance of receiving placebo. Each participant takes 6 capsules a day: 3 in the morning and 3 in the evening. The capsules can be opened and sprinkled on food if the child is unable to swallow them. Parents complete an electronic diary every day and send results by phone line for the duration of the study.

If the child has not been diagnosed with autism, a study clinician can do an evaluation. All evaluations and medication are free. Families who participate will receive small payments for lost work time or sitter costs, and the child will receive a small token for participating. If your child has autistic symptoms and stomach or bowel problems, and the idea of an investigational medication interests you, please contact Crowl at 614-688-8214 or crowl.15@... for more information.