The Beach Study
Research type
Research Study
Full title
Babies with Enterocolitis - A study of faecal Calprotectin in Hirschsprung disease
IRAS ID
336089
Contact name
Rachel Harwood
Contact email
Sponsor organisation
Alder Hey Children's NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
The BEACH study aims to gain preliminary data on the faecal calprotectin levels of young children with Hirschsprung's disease and whether these levels can be used to predict which children are at higher risk of enterocolitis and whether the faecal calprotectin level can predict the severity of an episode of enterocolitis.
Infants and children with Hirschsprung's disease do not have a normal nerve supply to their bowel which means that they cannot empty their bowels normally and need an operation to remove the affected portion of bowel. These children are at risk of developing a life-threatening condition called enterocolitis where the bowel becomes very inflamed. Known risk factors for enterocolitis include having a longer segment of affected bowel, having an underlying condition such as Trisomy 21 and being under 2 years of age. However, children without these risk factors can also develop recurrent enterocolitis which in some children can be life-threatening.Faecal calprotectin is a marker used routinely for assessing and monitoring people with inflammatory bowel disease. This preliminary study aims to recruit 50 infants and children under 5 years of age with Hirschsprung's Disease and monitor their faecal calprotectin levels at least 4 times over the 2 year duration of the study with samples to be provided during elective and emergency admissions. Parents will be asked about their child's bowel habits and diet with each stool sample and will be asked about the acceptability of collecting a stool sample with each specimen provided.
The information obtained during this study will be analysed according to a pre-determined plan to assess whether there is the potential for faecal calprotectin to be used as a biomarker and, if there is, to provide data to enable these studies to be powered appropriately.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
24/PR/0848
Date of REC Opinion
24 Jul 2024
REC opinion
Favourable Opinion