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
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.
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
Probiotic Supplementation for the Probiotics Group:
The probiotic formulation included:
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.
Exclusion Criteria:
Dietary Supplement: Saccharomyces Boulardii Probiotic Supplement
• Saccharomyces boulardii (strain CNCM I-745): 250 mg per day (5 billion colony-forming units (CFU)
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
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
The radiological outcome
The serial changes in the radiological images.
Time frame: 3 months
Plan to share: Undecided
No publications or documents are linked to this record.
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Aswan University Hospital