A Trial on Probiotics in Preventing Hirschsprung's Disease Associated Entercolitis

Early Phase 1

Completed

• Conditions: Probiotics; Hirschsprung's Disease Associated Enterocolitis
• Interventions: Drug: Bifico

• Registration Number: NCT01934959
• Lead Sponsor: Tongji Hospital

Brief Summary

Enterocolitis(EC) is the most common and serious postoperative complication of Hirschsprung's disease(HD) with high morbidity and mortality. Probiotics are live microbes that, when administered in adequate amounts, confer health benefit to the host.Based on this previous knowledge on the beneficial effects of probiotics during pro-inflammatory conditions of the gastrointestinal tract, investigators hypothesized that oral probiotics could decrease the incidence and severity of Hirschsprung's disease associated enterocolitis(HAEC).Investigators conducted a prospective, multicenter, randomized and controlled trial to assess whether oral probiotics could decrease the incidence and severity of Hirschsprung's disease associated enterocolitis(HAEC).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2010-01
• Status Verified: 2013-08
• Study First Submitted: 2013-08-21
• Study First Submitted QC: 2013-08-29
• Last Update Submitted: 2013-08-29
• Study First Posted: 2013-09-04
• Last Update Posted: 2013-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

The inclusion criteria consists of all patients suffering from HD at an age of less than 13 years old, and HD is confirmed by postoperative pathological examination, barium enema and anorectal manometry.

Exclusion Criteria

• Age> 13 years old
• Patients are complicated with mental, neurological disorders (such as hypoxic-ischemic encephalopathy, epilepsy and dementia) or can not thrive.
• Patients are complicated with congenital gastrointestinal malformations (such as anal stenosis, intestinal atresia stenosis), metabolic and endocrine diseases caused by organic constipation and functional constipation in children.
• Children are complicated with liver, kidney dysfunction, blood disorders, immune deficiency diseases and significant ECG abnormalities.
• Children have taken oral antibiotics, microecological modulator, yogurt, other gastrointestinal motility drugs which can affect the gut flora.
• Drug allergies, or allergic diseases..
• Poor compliance with oral probiotics treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Probiotics	Bifico	-

Primary Outcome Measures

Name	Time	Method
Probiotics Prevent Hirschsprung's Disease Associated Entercolitis	two years