Phase 2 Completed N=62 Randomized Triple-blind Prevention

Probiotic Prophylaxis of Hirschprung's Disease Associated Enterocolitis (HAEC)

Source: ClinicalTrials.gov NCT00630838 ↗

Enrolled (actual)

Serious AEs

28.3%

Results posted

Jul 2016

Primary outcomePrimary: Number of Patients Diagnosed With Hirschsprung-associated Enterocolitis (HAEC). — 10; 7 participants — p==0.897

Summary

Prospective, randomized, controlled trial to test if post-operative administration of probiotics in HD patients will lead to a reduction in the occurrence of HAEC.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients Diagnosed With Hirschsprung-associated Enterocolitis (HAEC).	10; 7	=0.897
PRIMARY Severity of Clinical Episodes of HAEC	3; 6; 6; 0; 1; 1	—

Eligibility Criteria

Inclusion Criteria

Patients eligible for enrollment will include all pediatric patients suffering from HD at an age of 12 months or younger. All patients will require consent by either parent or adult guardian

Exclusion Criteria

Patients will be excluded if children that are deemed hemodynamically unstable and require immediate operative intervention, age more than one year of age, as this may mean very delay in diagnosis and may affect the study results, or infants having major congenital anomalies with short life expectancy. Additional exclusion criteria are those patients' parents or adult guardian who refuse to undergo randomization. Finally, those children who are transferred to another non-participating hospital will be excluded.

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Data sourced from ClinicalTrials.gov (NCT00630838). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.