Helen DeVos Children’s Hospital first in country to complete clinical trial
GRAND RAPIDS, Mich., April 4, 2013 – A Spectrum Health clinical trial has found that fecal microbial transplantation (FMT) has resulted in the improvement or absence of symptoms in most pediatric patients with active ulcerative colitis.
The phase I clinical trial of the procedure was conducted by members of the Pediatric Specialty Department of the Spectrum Health Medical Group at Helen DeVos Children’s Hospital, the first in the country to study FMT in children. FMT is a process that involves infusion of human stool from a healthy donor into the intestine of the patient in an attempt to restore healthy microbial flora in the intestines of the patient.
When used to treat a disease, human stool constitutes a drug and a biologic. Therefore, an investigational new drug approval was obtained from the United States Food and Drug Administration (FDA) to utilize FMT for treating ulcerative colitis in this trial.
The study results have been published online by the Journal of Pediatric Gastroenterology & Nutrition and will be featured in the June print edition.
FMT has been proposed as a promising new treatment option for recurrent C. difficle infection and possibly for ulcerative colitis as well,” said Sachin Kunde, MD, MPH, pediatric gastroenterologist, Spectrum Health Medical Group, and lead investigator. “We believe that the procedure may restore ‘abnormal’ bacteria to ‘normal’ in patients with ulcerative colitis. Our short-term study looked at the safety and tolerability of FMT for these patients.
According to the National Institutes of Health, ulcerative colitis is a type of inflammatory bowel disease (IBD) that affects the lining of the large intestine, or colon, and rectum. Symptoms can present slowly or occur suddenly and include abdominal pain, cramping, bloody diarrhea, pus in the stool, fever, rectal pain, weight loss, nausea, vomiting, joint pain, mouth sores or skin lesions and slow growth in children. For children, the disease often means missing school and curbing social activities which can lead to isolation from peers. This can be a significant psychological burden on children and their families.
Fecal microbial transplantation found to be possible treatment
EurekAlert (press release)
GRAND RAPIDS, Mich., April 4, 2013 – A Spectrum Health clinical trial has found that fecal microbial transplantation (FMT) has resulted in the improvement or absence of symptoms in most pediatric patients with active ulcerative colitis. The phase I …and more »