NCT01985646

Brief Summary

The present study was designed to compare the efficacy of conservative treatment to operative treatment for improvement of constipation symptoms in infants with short or normal-segment Hirschsprung disease.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-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

October 1, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 15, 2013

Completed
Last Updated

November 15, 2013

Status Verified

November 1, 2013

Enrollment Period

2.1 years

First QC Date

October 31, 2013

Last Update Submit

November 10, 2013

Conditions

Hirschsprung Disease

Keywords

Hirschsprung diseaseconservative treatmentsurgery treatmentinfants

Outcome Measures

Primary Outcomes (1)

  • the change of defecation frequence

    the changes of defecation frequence at 6\~12 months after treatment

    6~12 months

Secondary Outcomes (3)

  • stool pattern

    6~12 months

  • controlling defecation ability

    6~12 months

  • complications

    6~12 months

Study Arms (2)

surgery treatment

EXPERIMENTAL

one stage pull through left-colectomy

Procedure: surgery treatment

conservative treatment

EXPERIMENTAL

anal dilation, colonic lavage, oral probiotic

Behavioral: anal dilationBehavioral: colonic lavageDrug: oral probiotic

Interventions

surgery treatmentPROCEDURE

one staged pull-through left-colectomy

surgery treatment
anal dilationBEHAVIORAL

anal dilation

conservative treatment
colonic lavageBEHAVIORAL

colonic lavage

conservative treatment
oral probioticDRUG

oral probiotic

conservative treatment

Eligibility Criteria

AgeUp to 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Hard or firm stools for twice or less per week
  • Age were from newborn to 3 months
  • Histochemical acetylcholinesterase reaction (AChE) in rectal mucosa was positive
  • The narrowed distal bowel on barium enema was characterized as normal or short-segment Hirschsprung disease with a 24h barium retention

You may not qualify if:

  • Children \>3months of age
  • Patients presented severe inflammation or malnutrition, unconsciousness, and symptoms of a ruptured hollow viscus
  • Barium enema showed long-segment or total colonic aganglionic bowel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hirschsprung Disease

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Digestive System AbnormalitiesDigestive System DiseasesMegacolonColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

October 31, 2013

First Posted

November 15, 2013

Study Start

October 1, 2009

Primary Completion

November 1, 2011

Last Updated

November 15, 2013

Record last verified: 2013-11