File - Penn State Study of LDN for Crohn's in Children

[Please Note: as of March, 2011, Nurse Sandra Bingaman says they are still looking for children to add to this study. Please help spread the word.]


Does your child have Crohn's disease?

Researchers at Penn State Milton S. Hershey Medical Center need volunteers for a five-month study to determine whether naltrexone will offer relief to children suffering from symptoms of Crohn's Disease.

To be eligible for this study, children must:
* Be between six and 17 years old
* Have active Crohn's Disease, confirmed by endoscopy or X-ray
* Not have a surgical ostomy or ileorectal anastomosis
* Not be taking Prograft, Cellcept, Remicade, or Humira for four weeks prior to study entry
* Not be taking prednisone >10mg or Entocort >3mg

Participation in the study will include:
* Physicals and blood work
* Receiving naltrexone or an inactive substance for the first eight weeks, then receiving naltrexone for the
second eight weeks
* Keeping a diary and answering questionnaires
* Monthly follow-up appointments for five months

Costs for medication, office visits, and blood work are paid by the study.

Study director: Jill P. Smith, M.D., Medicine, Gastroenterology, and Hepatology

Collaborator: Doug Field, M.D., Pediatric Gastroenterology

To see if your child is eligible, call Sandra Bingaman, R.N., 717-531-8108.

This research study has been approved by the Institutional Review Board, under federal regulations, at Penn State Hershey Medical Center, Penn State College of Medicine.

U.Ed. MED 08-8757 RES Pull by 12/01/08 IRB 27793
(06/10/08)

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