Can a gut fatty acid given before surgery stop bowel problems in Hirschsprung's babies?

NCT ID NCT03660176

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Cancelled before anyone took part.

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First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Hirschsprung's disease is a rare birth defect where part of the bowel lacks nerve cells, causing blockage. Even after surgery to remove the affected section, many children still struggle with constipation, bloating, or a dangerous gut inflammation called enterocolitis. Researchers are testing whether daily butyrate enemas given for about 24 days before surgery can help the bowel recover faster and prevent these problems. The trial enrolls 58 newborns and infants with short-segment Hirschsprung's disease, randomly assigning them to butyrate enemas plus standard care or standard care alone, then following them for three years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sodium butyrate, a short-chain fatty acid given as a rectal enema
What this could lead to
If it works, butyrate enemas before surgery could become a way to prevent the bowel problems and serious gut inflammation that many children with Hirschsprung's disease face after their operation.
What could go wrong
This is a small trial in newborns with a rare disease, and the approach is still experimental. Butyrate enemas may not prevent postoperative problems, and the results may not apply to children with more extensive Hirschsprung's disease.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 58 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

May 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

7 days to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

The inclusion criteria are: * Newborn with a diagnosis of Hirschsprung's disease the 2 first months of life managed successfully with colonic decompressions/irrigations before curative surgery (usually performed 1-3 times a day) * Born at or after 35 weeks of gestation (37 weeks of amenorrhea) * With a 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) (Kapur, 2009) * Uncomplicated form (without enterocolitis as defined by the HAEC score and/or diverting colostomy) * Curative surgery and follow-up in one of the included centres * With consent of the 2 parents or legal(s) representative(s) * Absence of severe or lethal associated malformations * Affiliation with the French social security system The non-inclusion criteria are: * Long segment Hirschsprung's disease prior to the junction between the left colon and the sigmoid colon * Hirschsprung's disease not managed successfully with colonic decompressions/irrigations and requiring a diverting colostomy before the curative surgery * Hirschsprung-associated enterocolitis occurring before the randomization (as defined by the HAEC score) * Severe or lethal associated malformation, including Down syndrome * Intestinal associated malformations (intestinal atresia, gastroschisis, omphalocele, intestinal malrotation and volvulus) * Any pathological condition that can modify intestinal motility or intestinal transit time (cystic fibrosis, hypothyroidism) * Refusal of parent(s) or legal representative(s) * Neonates under tutorship or guardianship Minors cannot be excluded because they are the population to be studied. The non-inclusion criteria are: * Long segment Hirschsprung's disease prior to the junction between the left colon and the sigmoid colon * Hirschsprung's disease not managed successfully with colonic decompressions/irrigations and requiring a diverting colostomy before the curative surgery * Hirschsprung-associated enterocolitis occurring before the randomization (as defined by the HAEC score) * Severe or lethal associated malformation, including Down syndrome * Intestinal associated malformations (intestinal atresia, gastroschisis, omphalocele, intestinal malrotation and volvulus) * Any pathological condition that can modify intestinal motility or intestinal transit time (cystic fibrosis, hypothyroidism) * Refusal of parent(s) or legal representative(s) * Neonates under tutorship or guardianship Minors cannot be excluded because they are the population to be studied. The non-inclusion criteria are: * Long segment Hirschsprung's disease prior to the junction between the left colon and the sigmoid colon * Hirschsprung's disease not managed successfully with colonic decompressions/irrigations and requiring a diverting colostomy before the curative surgery * Hirschsprung-associated enterocolitis occurring before the randomization (as defined by the HAEC score) * Severe or lethal associated malformation, including Down syndrome * Intestinal associated malformations (intestinal atresia, gastroschisis, omphalocele, intestinal malrotation and volvulus). * Any pathological condition that can modify intestinal motility or intestinal transit time (cystic fibrosis, hypothyroidism) * Refusal of parent(s) or legal representative(s) * Neonates under tutorship or guardianship Minors cannot be excluded because they are the population to be studied.

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Conditions

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As listed by the trial registrant

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Contacts and locations

Locations

  • Assistance Publique Des Hopitaux de Marseille

    Marseille, PACA, 13354, France

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