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CompletedNCT07098494Updated Aug 1, 2025

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

An interventional study of Saccharomyces Boulardii Probiotic Supplement in Hirschsprung Disease, Enterocolitis and Hirschsprung's Disease Associated Enterocolitis, sponsored by Aswan University Hospital. Completed at 1 site in Egypt. Open to participants aged 2 Months to 12 Years. Per ClinicalTrials.gov, last updated 2025-08-01.

Sponsored by Aswan University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Not applicable
Ages
2 Months to 12 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Hirschsprung Disease
  • Enterocolitis
  • Hirschsprung's Disease Associated Enterocolitis

Keywords

  • Hirschsprung disease
  • enterocolitis
  • Saccharomyces boulardii
  • HAEC
03

Who can participate

Ages eligible
2 Months to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
88 participants (actual)

Study arms

  • Experimental
    Saccharomyces boulardii probiotics

    Dietary Supplement: Saccharomyces Boulardii Probiotic Supplement

Interventions

  • Dietary supplementSaccharomyces Boulardii Probiotic Supplement

    • Saccharomyces boulardii (strain CNCM I-745): 250 mg per day (5 billion colony-forming units (CFU)

05

What researchers measure

Primary outcomes

  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.

    Time frame: 3 MONTHS

Secondary outcomes

  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.

    Time frame: 3 months

  2. The radiological outcome

    The serial changes in the radiological images.

    Time frame: 3 months

06

Study locations

1 site
  • Aswan University Hospital
    Aswān, Egypt
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07098494
Lead sponsor
Aswan University Hospital
Responsible party
Sarah Magdy Abdelmohsen (Dr., Aswan University Hospital) — Principal investigator
First posted
Aug 1, 2025
Start date
Jan 1, 2018
Primary completion
Sep 29, 2024
Completion
Sep 30, 2024
Last update
Aug 1, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
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