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.
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
- Conditions the study is for
- Hirschsprung Disease, Enterocolitis, Hirschsprung's Disease Associated Enterocolitis
- 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.
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 group | Role | What they receive |
|---|---|---|
| Saccharomyces boulardii probiotics | Experimental | Not 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.
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)
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
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.
- First posted1 Aug 2025
- Study start1 Jan 2018
- Primary completion29 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hirschsprung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Magdy Abdelmohsen, Aswan University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Probiotics Serve as an Adjuvant Therapy for Post-Pullthrough Hirschsprung's Disease-Associated Enterocolitis?
- ClinicalTrials.gov ID
- NCT07098494
- Acronym / sponsor ID
- AswanUH8
- Keywords
- Hirschsprung disease, enterocolitis, Saccharomyces boulardii, HAEC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 29 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Saccharomyces boulardii probiotics | Experimental | Dietary Supplement: Saccharomyces Boulardii Probiotic Supplement |
Who may qualify
- Ages
- 2 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children under 12 years of age
- a grade II post-pullthrough HAEC episode.
Key exclusion criteria (8 listed)
- patients with severe comorbidities.
- hemodynamic instability.
- active septicemia
- grade III HAEC
- trisomy 21
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saccharomyces Boulardii Probiotic Supplement• Saccharomyces boulardii (strain CNCM I-745): 250 mg per day (5 billion colony-forming units (CFU) | Dietary supplement | Saccharomyces boulardii probiotics |
Primary outcome
The clinical outcome as resolution of HAEC symptoms.
Time frame: 3 MONTHS
It included the clinical outcome as resolution of HAEC symptoms; defined by improvement of fever, diarrhea, and abdominal distension.
2 secondary outcomes
The laboratory outcome
Time frame: 3 months
The radiological outcome
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.