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The purpose of this multi-center research study is to evaluate the effectiveness and safety of linaclotide for the treatment of irritable bowel syndrome (IBS) with constipation in children. Linaclotide is approved for use in adults for treatment of constipation, but has not previously been studied in children.
Subject to certain exclusion criteria, the study is accepting patients of both genders, ages 7 through 17 years, who have met the modified Rome III criteria for IBS for at least 2 months prior to the initial screening visit.
Boys and Girls: Ages 7 through 17 years
Following a 4-week screening period and 2- to 3-week pretreatment period, participants will be randomly assigned to receive either the linaclotide study drug or a placebo to take by mouth once a day for 4 weeks. Participants age 6 to 11 will take a liquid solution, and older participants will take either a capsule or liquid solution. During study visits, patients will receive physicals, testing, and instructions on lifestyle modifications to help treat constipation.
Duration: About 12 weeks
Forest Research Institute
Study Description at National Institutes of Health
Irritable Bowel Syndrome
Constipation, Age 11 and Younger
Constipation, Age 12 and Older
Arvind I. Srinath, MD
For more information about the study or enrollment, please contact:
Amy Bookser, RN
Children's Hospital's main campus is located in the Lawrenceville neighborhood. Our main hospital address is:
UPMC Children’s Hospital of Pittsburgh
One Children’s Hospital Way
4401 Penn Ave.
Pittsburgh, PA 15224
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