Can a gut fatty acid given before surgery stop bowel problems in Hirschsprung's babies?
NCT ID NCT03660176
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.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Hirschsprung's disease are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Assistance Publique Des Hopitaux de Marseille
Marseille, PACA, 13354, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.