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Study of sodium butyrate enemas for bowel function recovery after surgery in children and adults with Hirschsprung's disease

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study examines Hirschsprung's disease, a condition present from birth where nerve cells are missing from parts of the intestine, causing problems with passing stool. The condition affects the lower part of the bowel, specifically the rectum and sometimes the sigmoid colon, which is the curved part of the large intestine just above the rectum. The study will use sodium butyrate enemas, which are liquid treatments inserted into the rectum. Butyrate is a substance naturally produced by bacteria in the intestine. A diagnostic agent will also be used during the study to help assess how the intestine is working.

The purpose of the study is to see if using butyrate enemas before surgery can help shorten the time it takes for normal bowel function to return after the operation that corrects Hirschsprung's disease. The study will involve newborns who have been diagnosed with the short-segment form of Hirschsprung's disease in their first two months of life. These infants will have been successfully managed with bowel irrigations before their corrective surgery. The treatment with butyrate enemas will be given before the surgery takes place.

During the study, doctors will measure how long it takes for the bowel to start working normally again after surgery. They will also watch for signs of bowel blockage symptoms after the operation, check stool consistency using a standard scale designed for children, measure how long it takes for food to pass completely through the intestine using a red dye called carmine, and monitor for any episodes of inflammation of the intestine. The study will also include measuring a substance called calprotectin in the stool, which helps show if there is inflammation in the intestine.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Preoperative preparation with butyrate enemas

    Before the curative surgery, enemas containing sodium butyrate will be administered. Sodium butyrate is a substance that may help improve intestinal function.

    The enema solution contains 1.1 grams of sodium butyrate per liter.

    The enemas will be administered rectally, meaning through the rectum, as part of the preparation for surgery.

    The specific timing and frequency of enema administration before surgery will be determined by the medical team.

  2. Step 2

    Curative surgery for Hirschsprung's disease

    The surgery will be performed to treat Hirschsprung's disease, a condition affecting the large intestine where nerve cells are missing in part of the bowel.

    The surgery aims to remove the affected portion of the intestine and restore normal bowel function.

    This is the main treatment procedure in the study.

  3. Step 3

    Recovery period and monitoring of bowel function

    After surgery, the time it takes for normal bowel function to return will be carefully measured. This is the main focus of the study.

    The medical team will observe when bowel movements resume and how the intestines are functioning.

    Any symptoms of intestinal blockage will be assessed, which means checking if the intestines are having difficulty moving food and waste through the digestive system.

  4. Step 4

    Stool consistency evaluation

    The consistency and form of stools will be evaluated using the Bristol stool form scale, which is a chart that classifies stool into different types based on appearance.

    This scale has been modified specifically for children to make it more appropriate for pediatric patients.

    This assessment helps determine how well the digestive system is working after surgery.

  5. Step 5

    Intestinal transit time measurement

    A test will be performed to measure how long it takes for food to travel through the entire digestive system.

    This will be done using red carmine, a harmless colored substance taken by mouth.

    The time from when the substance is swallowed until it appears in the stool will be recorded, providing information about intestinal movement speed.

  6. Step 6

    Monitoring for enterocolitis episodes

    The medical team will watch for any episodes of enterocolitis, which is inflammation of the intestines that can occur in patients with Hirschsprung's disease.

    This will be assessed using a specific scoring system called the HAEC score, which helps identify and grade the severity of this complication.

    Any such episodes will be documented and their severity will be classified.

  7. Step 7

    Fecal calprotectin measurement

    Fecal calprotectin is a protein found in stool that indicates inflammation in the intestines.

    A stool sample will be collected and analyzed to measure the level of this protein.

    This test provides information about intestinal inflammation and helps assess recovery.

  8. Step 8

    Follow-up period

    Regular follow-up visits will occur at the treatment center to monitor recovery and intestinal function.

    The medical team will continue to assess bowel function and overall recovery from surgery.

    The study is expected to continue collecting information until August 2031.

Who can join the trial?

8 criteria

  • The newborn must have been diagnosed with Hirschsprung's disease, which is a condition affecting the bowel, within the first two months of life and must have been successfully managed with bowel decompression or washing procedures before the main surgery
  • The baby must have been born at or after 35 weeks of pregnancy, which means at least 37 weeks since the mother's last menstrual period
  • The disease must be of the short-segment type, meaning it affects only the rectum, which is the last part of the bowel, and possibly the sigmoid colon, which is the section of bowel just before the rectum. This must be confirmed by a tissue sample taken from the rectum showing the absence of certain nerve cells and possibly enlarged nerve fibers
  • The disease must be uncomplicated, meaning the baby has not developed enterocolitis, which is a serious inflammation of the intestines, and has not required a colostomy, which is a surgical opening in the abdomen to divert stool
  • The curative surgery and follow-up care must take place at one of the participating medical centers
  • Both parents or legal guardians must provide their consent for the baby to participate in the study
  • The baby must not have any other severe or life-threatening birth defects
  • The family must be affiliated with the French social security system

Who cannot join the trial?

1 criterion

  • No exclusion criteria have been specified for this clinical trial in the available information.
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Investigated drugs

Butyrate enemas are a treatment given as an enema, which means the medication is inserted into the rectum (the lower part of the intestine). Butyrate is a natural substance that helps support the health of the cells lining the intestines. In this study, butyrate enemas are being tested to see if they can help patients recover normal bowel function more quickly after surgery for Hirschsprung's disease. The enemas are given before the surgery to prepare the intestines and potentially improve how well they work after the operation.

What is already known about the treatment

Butyrate – Butyrate is a short-chain fatty acid that is administered as an enema (a liquid solution inserted into the rectum) in this clinical trial for patients with Hirschsprung's disease, a condition affecting the large intestine's ability to move stool. This substance is being studied to see if it can help the bowels start working normally again faster after surgery by nourishing the cells lining the intestine and reducing inflammation. Butyrate works at the cellular level by providing energy to colon cells and helping to maintain the healthy function of the intestinal lining. It belongs to the class of nutritional supplements and is naturally produced by beneficial bacteria in a healthy gut, though in this study it is being tested as a medical treatment given directly into the intestine.

Investigated diseases

Hirschsprung's Disease – Hirschsprung's disease is a condition that affects the large intestine and causes problems with passing stool. The disease occurs when nerve cells that control the muscles of the colon are missing in a section of the bowel. Without these nerve cells, the affected part of the intestine cannot push stool through properly, leading to a blockage. This results in severe constipation or complete bowel obstruction in newborns and young children. The intestine above the affected area may become enlarged as stool accumulates. Children with this condition may experience ongoing bowel problems even after surgical correction.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2025-523094-42-00Protocol codeRCAPHM18_0018Estimated enrolment58 patientsSponsorCentre Hospitalier Regional De Marseille

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