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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01934959
Recruitment Status : Completed
First Posted : September 4, 2013
Last Update Posted : September 4, 2013
Anhui Provincial Hospital
Information provided by (Responsible Party):
Jiexiong Feng, 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).

Condition or disease Intervention/treatment Phase
Probiotics Hirschsprung's Disease Associated Enterocolitis Drug: Bifico Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective Multicenter Randomized Controlled Trial on Probiotics in Preventing Hirschsprung's Disease Associated Entercolitis
Study Start Date : January 2008
Primary Completion Date : January 2010

Arm Intervention/treatment
Experimental: Probiotics Drug: Bifico

Primary Outcome Measures :
  1. Probiotics Prevent Hirschsprung's Disease Associated Entercolitis [ Time Frame: two years ]

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Ages Eligible for Study:   1 Month to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jiexiong Feng, Chief of Pediatric Surgery, Tongji Hospital Identifier: NCT01934959     History of Changes
Other Study ID Numbers: Tongji
First Posted: September 4, 2013    Key Record Dates
Last Update Posted: September 4, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Hirschsprung Disease
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Digestive System Abnormalities
Colonic Diseases
Congenital Abnormalities