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

Probiotics Clinical Trial

Official title:

A Prospective Multicenter Randomized Controlled Trial on Probiotics in Preventing Hirschsprung's Disease Associated Entercolitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01934959
• Other study ID #: Tongji
• Status: Completed
• Phase: Phase 0
• First received: August 21, 2013
• Last updated: August 29, 2013
• Start date: January 2008

Study information

• Verified date: August 2013
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 13 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Bifico

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Tongji Hospital	Anhui Provincial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probiotics Prevent Hirschsprung's Disease Associated Entercolitis		two years	Yes