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Clinical Trials in the EU / 2025-523094-42-00
Authorised Phase III

Effects of butyrate enemas on postoperative intestinal motility disorders in Hirschsprung’s disease

2025-523094-42-00 · tracked via the Priya Life Science EU tracker
Sponsor
Assistance Publique Hopitaux De Marseille
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Decision date
16/12/2025
Enrollment target
58
Sites
France

Condition studied

Hirschsprung's disease

Investigational medicinal product(s)

-Sodium butyrate 11 g/L sol prep

Eligibility

Age group
0-17 years
Sex
Female, Male

Primary endpoint

Time to recovery of bowel function after the curative surgery

Endpoint detail

Assessmenof postoperative functional intestinal obstructive symptoms, Stool consistency evaluated using the validated ‘Bristol’ stool form scale modified for children, Red carmine total intestinal transit time measured, HAEC episode(s) defined by the HAEC score (Pastor et al., 2009; Frykman et al., 2017) and grading of HAEC (Gosain et al, 2017)., Fecal calprotectin measurement

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-523094-42-00 on CTIS ↗ ← All trials in the EU