MedTrace Logo

Babies With Enterocolitis - A Study of Faecal Calprotectin in Hirschsprung Disease (The BEACH Study)

NCT06592534 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-09-19

No results posted yet for this study

Summary

Babies with Hirschsprung's Disease are born without normal nerves to the end of their bowel which means they cannot poo properly, and are at high risk of infection of the bowel, called enterocolitis. 1 in 4 children with Hirschsprung's Disease develop enterocolitis and, if not treated quickly, it can lead to death. The symptoms include a swollen tummy, temperatures and diarrhoea but it can be hard to spot, especially in the early stages, and there is no test for it.

In some diseases, a substance called calprotectin is found in the poo when the bowel is inflamed. The investigators plan to collect poo samples from children with Hirschsprung's Disease and measure the calprotectin, to see if it can help the investigators predict which children are at highest risk of enterocolitis. When the investigators collect the poo we will ask parents some questions about their child's diet and poos over the week before, and how easy it was to collect the sample.

This is a pilot study, which means the investigators don't expect to get a definite answer to whether measuring calprotectin levels will change treatment for children with Hirschsprung's disease. However, it will help the investigators find out if calprotectin levels are a useful test for bowel inflammation in these children and will tell us what parents' views are on collecting poo samples regularly. If it does look like measuring calprotectin is a useful test in Hirschsprung's disease, the investigators will do more studies to find out if some children may benefit from more intensive treatment.

Conditions

  • Hirschprung's Disease
  • Hirschsprung Disease
  • Hirschsprung's Disease Associated Enterocolitis

Sponsors & Collaborators

  • Bowel Research UK

    collaborator UNKNOWN

  • Alder Hey Children's NHS Foundation Trust

    lead OTHER

Eligibility

Min Age
0 Days
Max Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2026-10-31
Completion
2026-10-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06592534 on ClinicalTrials.gov