Babies With Enterocolitis - A Study of Faecal Calprotectin in Hirschsprung Disease (The BEACH Study)
Launched by ALDER HEY CHILDREN'S NHS FOUNDATION TRUST · Sep 10, 2024
Trial Information
Current as of June 27, 2025
Not yet recruiting
Keywords
ClinConnect Summary
The BEACH Study is a clinical trial aimed at understanding how to better predict and manage enterocolitis in babies with Hirschsprung's Disease. Hirschsprung's Disease is a condition where babies are born without the normal nerves in part of their bowel, making it difficult for them to have bowel movements and increasing their risk of a serious infection called enterocolitis. This infection can happen in about 1 in 4 children with this condition and can be life-threatening if not treated quickly. The study will collect stool samples from babies under the age of 5 who have been diagnosed with Hirschsprung's Disease to measure a substance called calprotectin. This substance can indicate inflammation in the bowel, which may help researchers identify which children are at a higher risk of developing enterocolitis.
To participate in this study, children must be under 5 years old and have a confirmed diagnosis of Hirschsprung's Disease. During the study, parents will be asked to provide stool samples from their children and answer questions about their child's diet and bowel habits over the week before the sample collection. While this study is still in its early stages and won’t give a definite answer about changing treatments, it will help researchers determine if measuring calprotectin could be a useful tool for monitoring bowel inflammation in these children. Additionally, the study will gather feedback from parents about the process of collecting stool samples. If calprotectin proves to be helpful, further research may be conducted to determine if some children could benefit from more intensive treatment.
Gender
ALL
Eligibility criteria
- Inclusion criteria:
- • - Any infant or child under the age of 5 years at the time of recruitment with biopsy proven Hirschsprung's Disease
- Exclusion criteria:
- • Infants or children who do not have biopsy proven Hirschsprung's Disease
- • Individuals with total colonic Hirschsprung's Disease
- • Individuals with Hirschsprung's Disease which affects the small bowel
- • Children aged 5 years and over at the time of recruitment
- • Children with inflammatory bowel disease
About Alder Hey Children's Nhs Foundation Trust
Alder Hey Children's NHS Foundation Trust is a leading pediatric healthcare institution based in Liverpool, UK, dedicated to providing exceptional care for children and young people. Renowned for its commitment to advancing child health, the trust engages in innovative clinical research and trials that aim to improve treatment outcomes and enhance the quality of life for pediatric patients. With a multidisciplinary team of experts, Alder Hey fosters a collaborative environment focused on translating research findings into clinical practice, ensuring that the latest advancements in medicine directly benefit its diverse patient population.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported