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Hirschsprung DiseaseNCT07098494

Probiotics and Post-Pullthrough Hirschsprung's Disease-Associated Enterocolitis

A study testing Saccharomyces Boulardii Probiotic Supplement in people with Hirschsprung Disease and Enterocolitis, run by Aswan University Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This was a prospective case-controlled study investigating the role of probiotics in the management of Hirschsprung-associated enterocolitis (HAEC). The study was conducted across three children's hospitals in Upper Egypt, spanning from January 2018 to September 2024. Read more about this study

Who is it for?
Ages 2 months to 12 years
What is being tested?
Saccharomyces Boulardii Probiotic Supplement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteEgypt
Study dates
1 Jan 2018to 30 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 months to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • children under 12 years of age
  • a grade II post-pullthrough HAEC episode.

Who cannot join

  • patients with severe comorbidities.
  • hemodynamic instability.
  • active septicemia
  • grade III HAEC
  • trisomy 21
  • inability to tolerate or take oral probiotics
  • probiotic sensitivities
  • any contraindications to probiotic use.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Aswan University Hospital

    Aswān

Other trials in Egypt

About this study

Official title: Can Probiotics Serve as an Adjuvant Therapy for Post-Pullthrough Hirschsprung's Disease-Associated Enterocolitis?

This was a prospective case-controlled study investigating the role of probiotics in the management of Hirschsprung-associated enterocolitis (HAEC). The study was conducted across three children's hospitals in Upper Egypt, spanning from January 2018 to September 2024.

The study was randomized, with parents of the participating children choosing one of two paper forms to become either included in the probiotic treatment regimen or adhere to the standard treatment protocol without probiotics, the latter serving as the control group.

The inclusion criteria encompassed children under 12 years of age and admitted for treatment of a grade II post-pullthrough HAEC episode. Exclusion criteria included patients with severe comorbidities, hemodynamic instability, active septicemia, grade III HAEC, other congenital anomalies, trisomy 21, inability to tolerate or take oral probiotics, probiotic sensitivities, or any contraindications to probiotic use.

Read the detailed description

This was a prospective case-controlled study investigating the role of probiotics in the management of Hirschsprung-associated enterocolitis (HAEC). The study was conducted across three children's hospitals in Upper Egypt, spanning from January 2018 to September 2024. Diagnosis of Hirschsprung disease (HD) was confirmed through rectal biopsy prior to any surgical intervention. The study was randomized, with parents of the participating children choosing one of two paper forms to become either included in the probiotic treatment regimen or adhere to the standard treatment protocol without probiotics, the latter serving as the control group.

The inclusion criteria encompassed children under 12 years of age and admitted for treatment of a grade II post-pullthrough HAEC episode. Exclusion criteria included patients with severe comorbidities, hemodynamic instability, active septicemia, grade III HAEC, other congenital anomalies, trisomy 21, inability to tolerate or take oral probiotics, probiotic sensitivities, or any contraindications to probiotic use.

Demographic and clinical data were extracted from the medical records, clinical history taken and follow-up, including age, sex, comorbidities, HAEC grade, laboratory parameters, imaging findings, and treatment details. Outcome measures included resolution of HAEC symptoms, duration of hospital stay, recurrence rates, and any complications. Follow-up data were collected for six months following the resolution of acute HAEC symptoms.

The management protocol and medications for standard group

  • A clear liquid or nothing by mouth, nasogastric decompression, intravenous fluids calculated by pediatric physician according to the body weight, rectal irrigations once per day.
  • Metronidazole 10 mg/kg/dose IV 8 hrs × 10 days, Max. 500 mg/dose. Administer undiluted solution over 20 to 30 minutes.
  • Broad spectrum antibiotics as Ampicillin and gentamicin. The pediatrics dose of Ampicillin for children less than 40 kg was 50 mg/kg/day IM or IV in equally divided doses every 8 hours. For children at least 40 kg or more the dose was 500 mg IM or IV every 8 hours. The pediatric dose of gentamicin was 2 to 2.5 mg/kg IM or IV every 8 hours for 7 to 10 days.
  • For fever, Perfalgan IV in a dose of 15 mg/kg every 6 hours was useful.
  • PPI Omeprazole solution via enteral feeding tubes, in a dose of (1-3mg/kg once daily up to 1-year, max 20mg) (2 - 12 years: 10-19kg, max 20mg) (2 - 12 years: 20kg+, max 40mg).

Probiotic Supplementation for the Probiotics Group:

The probiotic formulation included:

  • Saccharomyces boulardii (strain CNCM I-745): 250 mg per day (5 billion colony-forming units (CFU)
  • Lactobacillus rhamnosus (strain GG): 5 billion CFU per day
  • Bifidobacterium infantis (strain 35624): 5 billion CFU per day
  • Administration:

The probiotics were administered in the form of a powder mixed with water or a small amount of clear liquid, ensuring ease of administration for pediatric patients. Probiotic supplementation was administrated once daily in the morning half an hour before any other types of oral feeding. Avoid concurrent antibiotics (space 2 hours apart). It continued for 3 months following the resolution of acute HAEC symptoms.

Being tested
Saccharomyces Boulardii Probiotic Supplement
Keywords
Hirschsprung disease, enterocolitis, Saccharomyces boulardii, HAEC
Medical subject headings
Hirschsprung Disease, Enterocolitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Saccharomyces Boulardii Probiotic SupplementDietary supplement

    • Saccharomyces boulardii (strain CNCM I-745): 250 mg per day (5 billion colony-forming units (CFU)
Study groups in NCT07098494
Study groupRoleWhat they receive
Saccharomyces boulardii probioticsExperimentalNot described
Receives: Dietary Supplement: Saccharomyces Boulardii Probiotic Supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The clinical outcome as resolution of HAEC symptoms.

    It included the clinical outcome as resolution of HAEC symptoms; defined by improvement of fever, diarrhea, and abdominal distension.

    Measured: 3 MONTHS

Secondary outcomes (2)
  1. The laboratory outcome

    The laboratory outcome as change in the inflammatory markers levels of C-reactive protein (CRP) and white blood cell (WBC) count before and after treatment.

    Measured: 3 months

  2. The radiological outcome

    The serial changes in the radiological images.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2025
  2. Study start1 Jan 2018
  3. Primary completion29 Sep 2024
  4. Study completion30 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07098494
Sponsor's protocol ID
AswanUH8
Status last verified
Jul 2025
First submitted
23 Jul 2025
Last updated
1 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Saccharomyces Boulardii Probiotic Supplement in people with Hirschsprung Disease and Enterocolitis, run by Aswan University Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The clinical outcome as resolution of HAEC symptoms. (time frame: 3 MONTHS). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.

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