SODIUM BUTYRATE for Hirschsprung's disease|Congenital megacolon

Inclusion criteria

• {"criterion_text":"- Newborn with a diagnosis of Hirschsprung’s disease the 2 first months of life managed successfully with colonic decompressions/irrigations before curative surgery"}
• {"criterion_text":"- Born at or after 35 weeks of gestation (37 weeks of amenorrhea)"}
• {"criterion_text":"- Short-segment Hirschsprung’s disease limited to the rectum and/or sigmoid colon diagnosed on rectal biopsy with established pathological criteria (absence of ganglionic cells +/- hypertrophic extrinsic nerve fibres)"}
• {"criterion_text":"- Uncomplicated form (without enterocolitis as defined by the HAEC score and/or diverting colostomy)"}
• {"criterion_text":"- Curative surgery and follow-up in one of the included centres"}
• {"criterion_text":"- With consent of the 2 parents or legal(s) representative(s)"}
• {"criterion_text":"- Absence of severe or lethal associated malformations"}
• {"criterion_text":"- Affiliation with the French social security system"}

Exclusion criteria

• {"criterion_text":"- Long segment Hirschsprung’s disease prior to the junction between the left colon and the sigmoid colon"}
• {"criterion_text":"- Hirschsprung’s disease not managed successfully with colonic decompressions/irrigations and requiring a diverting colostomy before the curative surgery"}
• {"criterion_text":"- Hirschsprung-associated enterocolitis occurring before the randomization"}
• {"criterion_text":"- Severe or lethal associated malformation, including Down syndrome"}
• {"criterion_text":"- Intestinal associated malformations (intestinal atresia, gastroschisis, omphalocele, intestinal malrotation and volvulus)"}
• {"criterion_text":"- Any pathological condition that can modify intestinal motility or intestinal transit time (cystic fibrosis, hypothyroidism)"}
• {"criterion_text":"- Refusal of parent(s) or legal representative(s)"}
• {"criterion_text":"- Neonates under tutorship or guardianship"}

Primary endpoints

• {"endpoint_text":"- Time to recovery of bowel function after the curative surgery","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Assessmenof postoperative functional intestinal obstructive symptoms","definition_or_measurement_approach":""}
• {"endpoint_text":"- Stool consistency evaluated using the validated ‘Bristol’ stool form scale modified for children","definition_or_measurement_approach":"Evaluated using the validated ‘Bristol’ stool form scale modified for children"}
• {"endpoint_text":"- Red carmine total intestinal transit time measured","definition_or_measurement_approach":"Measured using red carmine total intestinal transit time method"}
• {"endpoint_text":"- HAEC episode(s) defined by the HAEC score (Pastor et al., 2009; Frykman et al., 2017) and grading of HAEC (Gosain et al, 2017).","definition_or_measurement_approach":"HAEC episodes defined by HAEC score (Pastor et al., 2009; Frykman et al., 2017) and graded per Gosain et al., 2017"}
• {"endpoint_text":"- Fecal calprotectin measurement","definition_or_measurement_approach":"Fecal calprotectin measured (assay not further specified)"}

France

Earliest CTIS Part Ii Submission Date

21-11-2025

Latest Decision Or Authorization Date

16-12-2025

Processing Time Days

25

Number Of Sites

22

Number Of Participants

58

Primary sponsor

Full Name

Assistance Publique Hopitaux De Marseille

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France