NCT06590142 Hirschsprung's Advances; Working Towards Autologous tIssue therapIes
| NCT ID | NCT06590142 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Alder Hey Children's NHS Foundation Trust |
| Condition | Hirschsprung Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-03-05 |
| Primary Completion | 2034-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2024-03-05 with a primary completion date of 2034-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Children with Hirschsprung's Disease (HSCR) have no normal nerve cells in the lower end of their bowel. This can cause babies to die if left untreated treated. Currently the part of bowel that doesn't have normal nerves is removed with an operation, but this can have long-term complications including needing a permanent bag on the tummy for poo (stoma). Because of this there is an urgent need for better treatments. The investigators have found that children with HSCR have nerve stem cells throughout their bowel, even in the lower end where the nerves haven't grown normally. We can grow these stem cells in the laboratory to form balls of nerve cells (neurospheres). The investigators want to find out whether these neurospheres grow into the nerves that are needed for the bowel to work normally. First the investigators will see how the nerve stem cells from the lower end of the bowel grow compared to those from the normal bowel. Then the investigators will see if the neurospheres change when the investigators put them with medications that affect growth of bowel nerves. At the end of this project the investigators hope to know whether the nerve stem cells at the lower part of the bowel in children with HSCR can turn into bowel nerve cells that might make the bowel work normally. The investigators also hope to know whether the investigators can use medications to make the stem cells turn into normal nerves, meaning that children with HSCR could avoid an operation and a stoma.
Eligibility Criteria
Inclusion Criteria: • Any child undergoing therapeutic intestinal resection (but specifically those in which it is not necessary for all resected tissue to be sent for histopathological analysis, as no additional tissue will be removed for research purposes). Exclusion Criteria: • None
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06590142 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 15 Years, studying Hirschsprung Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06590142 currently recruiting?
Yes, NCT06590142 is actively recruiting participants. Contact the research team at rachel.harwood@alderhey.nhs.uk for enrollment information.
Where is the NCT06590142 trial being conducted?
This trial is being conducted at Liverpool, United Kingdom.
Who is sponsoring the NCT06590142 clinical trial?
NCT06590142 is sponsored by Alder Hey Children's NHS Foundation Trust. The trial plans to enroll 300 participants.