NCT01934959

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 4, 2013

Completed
Last Updated

September 4, 2013

Status Verified

August 1, 2013

Enrollment Period

2 years

First QC Date

August 21, 2013

Last Update Submit

August 29, 2013

Conditions

ProbioticsHirschsprung's Disease Associated Enterocolitis

Outcome Measures

Primary Outcomes (1)

  • Probiotics Prevent Hirschsprung's Disease Associated Entercolitis

    two years

Study Arms (1)

Probiotics

EXPERIMENTAL
Drug: Bifico

Interventions

BificoDRUG
Probiotics

Eligibility Criteria

Age1 Month - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 25370155DERIVED

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Pediatric Surgery

Study Record Dates

First Submitted

August 21, 2013

First Posted

September 4, 2013

Study Start

January 1, 2008

Primary Completion

January 1, 2010

Last Updated

September 4, 2013

Record last verified: 2013-08