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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01934959 |
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Date of registration:
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21/08/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Trial on Probiotics in Preventing Hirschsprung's Disease Associated Entercolitis
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Scientific title:
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A Prospective Multicenter Randomized Controlled Trial on Probiotics in Preventing Hirschsprung's Disease Associated Entercolitis |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01934959 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 0
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Key inclusion & exclusion criteria
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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.
Age minimum:
1 Month
Age maximum:
13 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hirschsprung's Disease Associated Enterocolitis
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Probiotics
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Intervention(s)
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Drug: Bifico
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Primary Outcome(s)
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Probiotics Prevent Hirschsprung's Disease Associated Entercolitis
[Time Frame: two years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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