About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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
Trial population
Infants and children will be identified during any admission to hospital, pre-operatively and during outpatient attendances.
Trial design
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Description of the change in baseline faecal calprotectin in infants with HSCR over time
This is a pilot study which aims to describe the baseline measurements and longitudinal changes observed in faecal calprotectin levels in children under the age of 7 years with Hirschsprung's Disease.
Secondary outcomes
Acceptability of repeated stool sampling
Validated questionnaire to determine the acceptability of repeated stool sampling. A score of 1 to 5 is given where 1 indicates poor acceptability and 5 indicates very good acceptance in each domain.
Locations
Sponsors and contacts
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Alder Hey Children's NHS Foundation Trust
Lead sponsor
Bowel Research UK
Collaborator
This trial is not recruiting at the moment. You can still explore other options: