A randomized multicenter open-label controlled trial to show that mucous fistula refeeding reduces the time from enterostomy closure to full enteral feeds (MUCous FIstula REfeeding ("MUC-FIRE") trial)

• Applicants: Professor Dr. Martin Lacher; Dr. Omid Madadi-Sanjani
• Subject Area: Pediatric and Adolescent Medicine
• Term: since 2017
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 316564369

The prospective, randomised, multi-centre research trial will investigate whether the mucous fistula refeeding (MFR) between enterostomy creation and enterostomy closure reduces the time to full enteral feeds after enterostomy closure compared to standard care. A total of 120 subjects will be recruited over a period of approximately 9 years in 15 study sites. 60 children will receive standardized stool refeeding and 60 children will be treated with a standard protocol without refeeding. Children under one year of age with a double loop enterostomy (ileostomy, jejunostomy), with an existing ileocecal valve, without small bowel atresia and without chromosomal diseases are included. The primary endpoint investigated is the time to full enteral feeds (in hours) after enterostomy closure. This is defined as the complete calorie intake (necessary for age) via enteral nutrition without parenteral supplements. A standardized nutrition protocol is followed. Secondary endpoints include daily postoperative weight gain (g per day), days with parenteral nutrition, laboratory cholestasis parameters (bilirubin, GGT, ALT, AST, urinary sodium) as well as postoperative complications and adverse events. After completion of the study, the results will be published and the study protocol with all data on the implementation of the MFR will be made available. If the analyses support the study hypothesis that mucous fistula refeeding between stoma creation and closure reduces the time to full enteral feeds, MFR will become the new standard of care for neonates with enterostomies.

• DFG Programme: Clinical Trials