NCT02350088

Brief Summary

To evaluate the safety and efficacy of Hirschsprung's disease

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable surgery

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
unknown

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, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 17, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 29, 2015

Status Verified

January 1, 2015

Enrollment Period

1.9 years

First QC Date

January 17, 2015

Last Update Submit

January 24, 2015

Conditions

Surgery

Keywords

fast-track surgery

Outcome Measures

Primary Outcomes (1)

  • number of participants with recovery of boewl movements

    one year

Secondary Outcomes (1)

  • Duration of the hospital stay

    one year

Study Arms (2)

Fast-track Surgery

ACTIVE COMPARATOR

probiotics,oral,b.i.d.

Drug: probiotics

Traditional Group

ACTIVE COMPARATOR

placebo,oral,b.i.d.

Drug: placebo

Interventions

probioticsDRUG

probiotics

Also known as: Bifico
Fast-track Surgery
placeboDRUG

placebo

Also known as: Bifico
Traditional Group

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • surgical treatment for Hirschsprung's disease
  • The first procedure for Hirschsprung's disease
  • Age\<14 years

You may not qualify if:

  • conservative treatment for Hirschsprung's disease
  • The reoperation for Hirschsprung's disease
  • Age\>14 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Zhi Li, MD PhD

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhi Li, MD PhD

CONTACT

+8613387664883lizhimdphd@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 17, 2015

First Posted

January 29, 2015

Study Start

January 1, 2014

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

January 29, 2015

Record last verified: 2015-01

Locations

CN(1)