Division of Gastroenterology, Hepatology and Nutrition

Safety and Immunogenicity of Rotavirus Vaccine (RotaTeq®) in Infants with Short Bowel Syndrome: A Pilot Study  

Principal Investigator: Christopher Duggan, MD, MPH

Department: Gastroenterology and Nutrition

Protocol Status: Open for Recruitment

Trial Description: The aim of this study is see how well the rotavirus vaccine works to boost the immune system to fight this infection in infants who have had a portion of their bowels removed by surgery.  This vaccine is taken orally and is recommended for all healthy infants to prevent rotavirus infection, but is experimental in infants who have had portions of their bowel removed since it has never before been studied in this group of infants.

Study procedures:  Participants will receive three doses of the RotaTeq® vaccine.  Blood samples will be taken prior to the first vaccine and two weeks after the last vaccine.  Physical exam and telephone follow-up will occur at regular intervals for 12 months following the first dose of the vaccine.

Compensation: $9 for parking reimbursement and $36 for time and inconvenience will be provided in the form of a $45 gift check, given at each of the eight required study visits.

Recruitment Info: Infants with short bowel syndrome who are clinically stable and between the ages of 6-12 weeks at the time of entry to the study.

Recruitment Contact Name: Lori Bechard

Recruitment Contact Phone: 617-355-5293

Recruitment Contact Email: lori.bechard@childrens.harvard.edu