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NCT Number: NCT03469609

Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds ("MUC-FIRE" Trial)

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.

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Key information

Conditions

Enterostomy Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Gastroenteritis Gastrointestinal Diseases Hyperphagia Intestinal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinik für Kinder- und Jugendchirurgie, Graz, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants < 366 days,
  • Ileostomy / Jejunostomy,
  • double loop enterostomies and split enterostomies (with mucous fistula)
  • Signed written informed consent obtained by parents/legal guardians and willingness of parents/legal guardians to comply with treatment and follow-up procedures of their child

Exclusion criteria

  • resection of ileocecal valve,
  • colostomy,
  • small bowel atresia,
  • multiple ostomies (more than just an enterostomy and a mucous fistula),
  • chromosomal abnormalities (if known at the time of randomization),
  • Hirschsprung's disease,
  • participation in another drug-intervention study
  • Intestinal perforation due to a hemodynamic heart defect

Treatment and study plan

mucous fistula refeeding

Other

Transfer of infants' own stool

Primary outcomes

  1. Time to full enteral feeds (hours)

    Time frame: week 4 to week 12 daily

    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.

    • 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.
    • The nutrition aim is 90 kcal/kg/24h for born mature infants, mother's gestation week at birth at least 37+0.

Secondary outcomes

  1. Time to first bowel movement

    Time frame: Week 4 to week 12 daily

    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

  2. Thriving

    Time frame: Week 1 to week 12 daily; follow-up (month 3, 6, 12)

    Measurement of body weight

  3. Z-Score (standard deviation score)

    Time frame: Week 1 to week 12 daily, follow-up (month 3, 6, 12)

    Measurement of weight [weight for age, World Health Organization (WHO)]

  4. Number of days of postoperative total parenteral nutrition (TPN)

    Time frame: Week 2 to week 12 daily, follow-up (month 3, 6, 12)

    Calculation of days of postoperative TPN starts on the day of operation and ends on the day of full enteral nutrition

  5. Laboratory parameter indicating cholestasis

    Time frame: Week 1 to week 12 daily, follow-up (month 3)

    Measurement of conjugated Bilirubin (µmol/l)

  6. Assessment of adverse events (AEs)

    Time frame: Week 1 to week 12 daily, follow-up (month 3, 6, 12)

    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.

  7. Assessment of serious adverse events (SAEs)

    Time frame: Week 1 to week 12 daily, follow-up (month 3, 6, 12)

    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.

  8. Postoperative weight gain (g/d)

    Time frame: week 4 to week 12

    Weight gain during the subsequent 5 days after reaching the primary endpoint following enterostomy closure

  9. Central venous line (CVL)

    Time frame: Week 1 to week 12

    duration (days) and number of CVL infections (definition of infection: Neo-Kiss Guidelines)

  10. hospitalisation

    Time frame: week 1 to week 12

    Length of hospital stay (days)

  11. jump in caliber

    Time frame: week 5

    Estimated ratio of the diameter of the two bowel loops which are anastomosed.

  12. Sodium resorption

    Time frame: Week 1 to week 12 daily, follow-up (month 3)

    Sodium in Urine (mmol/l)

  13. Status of liver enzymes

    Time frame: Week 1 to week 12 daily, follow-up (month 3)

    Gamma-Glutamyltransferase (GGT) , Alanine-Aminotransferase (ALT) , Aspartate-Aminotransferase (AST) (µkat/l)

  14. Laboratory parameters

    Time frame: Week 1 to week 12 daily, follow-up (month 3)

    Haemoglobin (g/dl)

  15. Time to full volume intake per day (in hours)

    Time frame: week 4 to week 12 daily

    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).

    • 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.
    • The volume aim is 120 ml/kg/24h for born mature infants, mother's gestation week at birth at least 37+0.

Study contacts

Contact information is provided by the study sponsor or research team.

Martin Lacher, Prof. Dr. med.

CONTACT

[email protected]

+49-341-97 ext. 26400

Omid Madadi-Sanjani, PD Dr. med.

CONTACT

[email protected]

+49-176 ext. 20192676

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Collaborators

  • German Research Foundation
  • Hannover Medical School

Registry information

Official study title

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)

Acronym: MUC-FIRE

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Mar 19, 2018
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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