Back to resultsA Trial on Probiotics in Preventing Hirschsprung's Disease Associated Entercolitis
Primary Purpose
Probiotics, Hirschsprung's Disease Associated Enterocolitis
Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Bifico
Sponsored by
About this trial
This is an interventional treatment trial for Probiotics
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Probiotics
Arm Description
Outcomes
Primary Outcome Measures
Probiotics Prevent Hirschsprung's Disease Associated Entercolitis
Secondary Outcome Measures
Full Information
NCT ID
NCT01934959
First Posted
August 21, 2013
Last Updated
August 29, 2013
Sponsor
Tongji Hospital
Collaborators
Anhui Provincial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01934959
Brief Title
A Trial on Probiotics in Preventing Hirschsprung's Disease Associated Entercolitis
Official Title
A Prospective Multicenter Randomized Controlled Trial on Probiotics in Preventing Hirschsprung's Disease Associated Entercolitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital
Collaborators
Anhui Provincial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Probiotics, Hirschsprung's Disease Associated Enterocolitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotics
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Bifico
Primary Outcome Measure Information:
Title
Probiotics Prevent Hirschsprung's Disease Associated Entercolitis
Time Frame
two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
25370155
Citation
Wang X, Li Z, Xu Z, Wang Z, Feng J. Probiotics prevent Hirschsprung's disease-associated enterocolitis: a prospective multicenter randomized controlled trial. Int J Colorectal Dis. 2015 Jan;30(1):105-10. doi: 10.1007/s00384-014-2054-0. Epub 2014 Nov 5.
Results Reference
derived
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A Trial on Probiotics in Preventing Hirschsprung's Disease Associated Entercolitis
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