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AuthorisedTherapeutic confirmatory (Phase III)Interventional

Effects of butyrate enemas on postoperative intestinal motility disorders in Hirschsprung’s disease

This research is investigating whether a treatment called a "butyrate enema" can help children with Hirschsprung's disease after they’ve had surgery. Hirschsprung's disease affects the large bowel. After surgery to fix this, some children can have problems with their bowel movements. This study aims to find out if giving a butyrate solution into the bottom helps the bowel start working properly again more quickly. Researchers will measure how fast children recover and if they have fewer problems like constipation or bowel infections. They are also looking to see if it improves stool consistency and how quickly food passes through their system.

At a glance

Status
Authorised
Phase
Therapeutic confirmatory (Phase III)
Sponsor
Assistance Publique Hopitaux De Marseille
Enrolment target
58
Start
16 Dec 2025

What is this study about?

This study is looking into a condition called Hirschsprung's disease, which is a rare problem that babies are born with. It affects the large bowel because some nerve cells are missing. This means that waste can't pass through easily, and it can cause severe constipation or blockages. The usual treatment for Hirschsprung's disease is surgery to remove the part of the bowel that doesn't have nerves.

After surgery for Hirschsprung's disease, some children can still have difficulties with their bowel movements. This might include issues like tummy pain, constipation, or even a serious problem called Hirschsprung-associated enterocolitis (HAEC), which is an infection or inflammation of the bowel. These problems can be worrying for both children and their families.

This study is testing a treatment called a "butyrate enema." An enema is when a liquid is gently put into the bottom. Butyrate is a natural substance that helps keep the gut healthy. Researchers want to see if giving this butyrate solution to children after their surgery helps their bowels recover and start working normally again more quickly. Basically, they are trying to find out if this treatment can make life easier for children as they recover.

Key takeaways

  • This study aims to improve recovery for children with Hirschsprung's disease after surgery.
  • It tests if a butyrate enema can help bowels work normally sooner.
  • Researchers will monitor how quickly children recover and if they have fewer problems like constipation.
  • The study includes children of all ages and genders needing Hirschsprung's surgery.
  • Participation involves close monitoring after surgery.

Who may be eligible?

This study is open to any child who has been diagnosed with Hirschsprung's disease and is going to have surgery to correct it.

There are no age limits for joining this study; both very young babies and older children can take part. Both boys and girls can be included. Your child’s medical team will check other specific health details to make sure this study is right for them.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Has your child been diagnosed with Hirschsprung's disease?
  2. Is your child scheduled to have surgery for Hirschsprung's disease soon?
  3. Is your child otherwise generally healthy enough to participate in a study?
  4. Are you comfortable with your child potentially receiving the butyrate solution via enema, or not receiving it?
Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will either receive the butyrate enema treatment or not, depending on which group they are assigned to. This treatment involves a liquid being gently given into your child's bottom. The study team will closely monitor your child's recovery after their surgery. This will involve checking how soon their bowels start working properly again. They will also keep track of any problems like constipation, bowel infections, or tummy pain.

You might be asked to help describe your child's stool (poo) using a special chart, and some simple tests might be done, like measuring how quickly food passes through their system or checking stool samples. The doctors will also carefully monitor any signs of bowel inflammation. The total length of your child's participation in the study will depend on how quickly they recover and what follow-up appointments are needed, but it will generally involve close monitoring for a period after surgery.

Potential risks and benefits

Taking part in any study has potential benefits and risks. For your child, a potential benefit could be that the butyrate enema helps their bowels recover faster and reduces problems after surgery, but this is what the study is trying to find out. There might be minor discomfort with the enema itself. Your child's doctor or nurse will explain all the known side effects of butyrate, though it is a natural substance. You have the right to withdraw your child from the study at any time, for any reason, without it affecting their medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    France

Common questions

What is Hirschsprung's disease?

It's a condition babies are born with where some nerve cells are missing in part of the large bowel, making it hard for poo to pass through.

What is a butyrate enema?

It's a special liquid containing butyrate (a natural substance good for the gut) that's gently put into the bottom.

Will my child definitely get the butyrate treatment?

Not necessarily. Participants are usually put into groups by chance; some get the treatment, and some don't, so doctors can compare the results fairly.

What is the main goal of this study?

The main goal is to see if the butyrate enema helps children’s bowels start working normally faster after surgery for Hirschsprung's disease.

Will taking part affect my child's usual care?

No, your child will still receive the best standard care for their condition, regardless of whether they join the study.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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