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

NCT07098494 | Completed DMC

• 1 other identifier: AswanUH8
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hirschsprung Disease; Enterocolitis; Hirschsprung's Disease Associated Enterocolitis

Keywords

Hirschsprung disease; enterocolitis; Saccharomyces boulardii; HAEC

Outcome Measures

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.

  3 MONTHS

Secondary Outcomes (2)

• The laboratory outcome

  3 months

• The radiological outcome

  3 months

Study Arms (1)

Saccharomyces boulardii probiotics

EXPERIMENTAL

Dietary Supplement: Saccharomyces Boulardii Probiotic Supplement

Interventions

Saccharomyces Boulardii Probiotic Supplement DIETARY_SUPPLEMENT

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

Saccharomyces boulardii probiotics

Eligibility Criteria

• Age: 2 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University Hospital

Aswān, Egypt

Location

MeSH Terms

Conditions

Hirschsprung Disease; Enterocolitis

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Megacolon; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gastroenteritis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: August 1, 2025
• Study Start: January 1, 2018
• Primary Completion: September 29, 2024
• Study Completion: September 30, 2024
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

EG (1)