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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-4
SponsorAlder Hey Children's NHS Foundation Trust

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

50 Participants
are grouped into 1 trial group
Group A: Infants and children with Hirschsprung's Disease

Trial outcomes

Primary outcomes

1

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.

Time frame
2 years

Secondary outcomes

1

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.

Time frame
2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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