An interventional study of mucous fistula refeeding in Enterostomy, sponsored by University of Leipzig. Recruiting at 17 sites in 3 countries. Open to participants aged Up to 12 Months. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by University of Leipzig · Not applicable, Interventional, and Treatment
The primary objective of this study is to demonstrate that mucous fistula refeeding between enterostomy creation and enterostomy closure reduces the time to full enteral feeds after enterostomy closure compared to standard of care.
Enterostomies in children may be created for different reasons. During the presence of an enterostomy the regular stool transfer is interrupted as the distal part of the bowel (the part following the enterostomy) does not participate in the circulation of stool. Therefore it does not contribute to the resorption of enteral contents. As a consequence these children need additional parenteral nutrition. Due to the negative side-effects of parenteral nutrition all patients should return to enteral nutrition as soon as possible. Consequently, many pediatric surgical centers worldwide routinely perform mucous fistula refeeding (MFR) into the former unused bowel after enterostomy creation because case reports and retrospective analyses show low complication rates and faster postoperative weight gain. Several providers, however, shy away from this approach because to date there is still no high quality evidence for the benefit of this Treatment.The aim of this study is to assess the effects of mucous fistula refeeding in a randomized, prospective trial. We hypothesize that MFR between enterostomy creation and enterostomy closure reduces the time to full enteral feeds after enterostomy closure compared to the group without refilling. Moreover, the side effects of parenteral nutrition may be reduced and the postoperative hospital care of infants undergoing ostomy closure shortened.
228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.
This study's planned enrollment of 120 is above the median of 103 across 127 interventional studies indexed under Enterocolitis, Necrotizing.
Browse Enterocolitis, Necrotizing studies →University of Leipzig is the lead sponsor of 148 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Perioperative mucous fistula refeeding between enterostomy creation and enterostomy closure
Other: mucous fistula refeeding
No perioperative mucous fistula refeeding
Transfer of infants' own stool
Time to full enteral feeds (hours)
Time to full feeds (hours), defined as time to actual enteral intake of the age-dependent caloric requirements per day (defined as 90 or 120kcal/kg/24h) for at least 24 hours and a concomitant reduction of parenteral fluids to \<20ml/kg/24h. 1. The nutrition aim is 120 kcal/kg/24h for premature infants with a birth weight \< 1000g or premature infants with a birth weight ≥ 1000g and mother's gestation week at birth before 37+0. 2. The nutrition aim is 90 kcal/kg/24h for born mature infants, mother's gestation week at birth at least 37+0.
Time frame: week 4 to week 12 daily
Time to first bowel movement
Cleaning and changing of infants diapers will be performed according to a fixed schedule in order to uniformly document the time to first bowel movement
Time frame: Week 4 to week 12 daily
Thriving
Measurement of body weight
Time frame: Week 1 to week 12 daily; follow-up (month 3, 6, 12)
Z-Score (standard deviation score)
Measurement of weight \[weight for age, World Health Organization (WHO)\]
Time frame: Week 1 to week 12 daily, follow-up (month 3, 6, 12)
Number of days of postoperative total parenteral nutrition (TPN)
Calculation of days of postoperative TPN starts on the day of operation and ends on the day of full enteral nutrition
Time frame: Week 2 to week 12 daily, follow-up (month 3, 6, 12)
Laboratory parameter indicating cholestasis
Measurement of conjugated Bilirubin (µmol/l)
Time frame: Week 1 to week 12 daily, follow-up (month 3)
Assessment of adverse events (AEs)
Adverse events will be collected by the investigator either based on the information provided spontaneously by the parents of patient or evaluated by non-suggestive questions.
Time frame: Week 1 to week 12 daily, follow-up (month 3, 6, 12)
Assessment of serious adverse events (SAEs)
Adverse events will be collected by the investigator either based on the information provided spontaneously by the parents of patient or evaluated by non-suggestive questions.
Time frame: Week 1 to week 12 daily, follow-up (month 3, 6, 12)
Postoperative weight gain (g/d)
Weight gain during the subsequent 5 days after reaching the primary endpoint following enterostomy closure
Time frame: week 4 to week 12
Central venous line (CVL)
duration (days) and number of CVL infections (definition of infection: Neo-Kiss Guidelines)
Time frame: Week 1 to week 12
hospitalisation
Length of hospital stay (days)
Time frame: week 1 to week 12
jump in caliber
Estimated ratio of the diameter of the two bowel loops which are anastomosed.
Time frame: week 5
Sodium resorption
Sodium in Urine (mmol/l)
Time frame: Week 1 to week 12 daily, follow-up (month 3)
Status of liver enzymes
Gamma-Glutamyltransferase (GGT) , Alanine-Aminotransferase (ALT) , Aspartate-Aminotransferase (AST) (µkat/l)
Time frame: Week 1 to week 12 daily, follow-up (month 3)
Laboratory parameters
Haemoglobin (g/dl)
Time frame: Week 1 to week 12 daily, follow-up (month 3)
Time to full volume intake per day (in hours)
Time to full age-dependent volume intake per day (defined as 150ml/kg/24h for premature infants and 120ml/kg/24h for mature born infants as well as corrected mature infants) (in hours). 1. The volume aim is 150 ml/kg/24h for premature infants with a birth weight \< 1000g or premature infants with a birth weight ≥ 1000g and mother's gestation week at birth before 37+0. 2. The volume aim is 120 ml/kg/24h for born mature infants, mother's gestation week at birth at least 37+0.
Time frame: week 4 to week 12 daily
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Plan to share: No
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