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

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ClinicalTrials.gov Identifier: NCT01934959
Recruitment Status : Completed
First Posted : September 4, 2013
Last Update Posted : September 4, 2013
Sponsor:
Collaborator:
Anhui Provincial Hospital
Information provided by (Responsible Party):
Jiexiong Feng, Tongji Hospital

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
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
Actual Primary Completion Date : January 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Probiotics Drug: Bifico


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

Eligibility Criteria
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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
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jiexiong Feng, Chief of Pediatric Surgery, Tongji Hospital
ClinicalTrials.gov Identifier: NCT01934959    
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:
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Enterocolitis
Hirschsprung Disease
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Intestinal Diseases
Digestive System Abnormalities
Megacolon
Colonic Diseases
Congenital Abnormalities