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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01934959
First Posted: September 4, 2013
Last Update Posted: September 4, 2013
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.
Collaborator:
Anhui Provincial Hospital
Information provided by (Responsible Party):
Jiexiong Feng, Tongji Hospital
  Purpose
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 Intervention Phase
Probiotics Hirschsprung's Disease Associated Enterocolitis Drug: Bifico Early Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Jiexiong Feng, Tongji Hospital:

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

Enrollment: 60
Study Start Date: January 2008
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotics Drug: Bifico

  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jiexiong Feng, Chief of Pediatric Surgery, Tongji Hospital
ClinicalTrials.gov Identifier: NCT01934959     History of Changes
Other Study ID Numbers: Tongji
First Submitted: August 21, 2013
First Posted: September 4, 2013
Last Update Posted: September 4, 2013
Last Verified: August 2013

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