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

NCT06592534 | Not Yet Recruiting

• 1 other identifier: 336089
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Faecal Calprotectin; Enterocolitis

Outcome Measures

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.

  2 years

Secondary Outcomes (1)

• Acceptability of repeated stool sampling

  2 years

Study Arms (1)

Infants and children with Hirschsprung's Disease

Children under the age of 7 years with Hirschsprung's Disease.

Eligibility Criteria

• Age: 0 Days - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants and children will be identified during any admission to hospital, pre-operatively and during outpatient attendances.

You may qualify if:

• \- Any infant or child under the age of 5 years at the time of recruitment with biopsy proven Hirschsprung's Disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Alder Hey Children's NHS Foundation Trust: lead
• Bowel Research UK: collaborator

MeSH Terms

Conditions

Hirschsprung Disease; Enterocolitis

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Megacolon; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gastroenteritis

Central Study Contacts

Rachel Harwood, FRCS PhD MRCS

CONTACT

+44 7709471898; rachel.harwood@alderhey.nhs.uk

Sarah Almond, FRCS (Paed)

CONTACT

Sarah.Almond@alderhey.nhs.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09