Trial record 4 of 8 for:
A Trial on Probiotics in Preventing Hirschsprung's Disease Associated Entercolitis
This study has been completed.
Anhui Provincial Hospital
Information provided by (Responsible Party):
Jiexiong Feng, Tongji Hospital
First received: August 21, 2013
Last updated: August 29, 2013
Last verified: August 2013
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).
Hirschsprung's Disease Associated Enterocolitis
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||A Prospective Multicenter Randomized Controlled Trial on Probiotics in Preventing Hirschsprung's Disease Associated Entercolitis
Primary Outcome Measures:
- Probiotics Prevent Hirschsprung's Disease Associated Entercolitis [ Time Frame: two years ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Primary Completion Date:
||January 2010 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||1 Month to 13 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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.
No Contacts or Locations Provided
No publications provided
||Jiexiong Feng, Chief of Pediatric Surgery, Tongji Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 21, 2013
||August 29, 2013
||China: Food and Drug Administration
United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Digestive System Diseases
Digestive System Abnormalities