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

This study has been completed.
Sponsor:
Collaborator:
Anhui Provincial Hospital
Information provided by (Responsible Party):
Jiexiong Feng, Tongji Hospital
ClinicalTrials.gov Identifier:
NCT01934959
First received: August 21, 2013
Last updated: August 29, 2013
Last verified: August 2013
  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
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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 Tongji Hospital:

Primary Outcome Measures:
  • Probiotics Prevent Hirschsprung's Disease Associated Entercolitis [ Time Frame: two years ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   1 Month to 13 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Jiexiong Feng, Chief of Pediatric Surgery, Tongji Hospital
ClinicalTrials.gov Identifier: NCT01934959     History of Changes
Other Study ID Numbers: Tongji
Study First Received: August 21, 2013
Last Updated: August 29, 2013
Health Authority: China: Food and Drug Administration
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014