NCT02255747

Brief Summary

This study is to evaluate the effect of anal dilation in infants and children with constipation.

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

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

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

September 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 3, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 3, 2014

Status Verified

September 1, 2014

Enrollment Period

1.9 years

First QC Date

September 28, 2014

Last Update Submit

September 30, 2014

Conditions

Constipation

Keywords

infants and children with constipation

Outcome Measures

Primary Outcomes (1)

  • Daily stool times

    two years

Secondary Outcomes (2)

  • The frequency of intestinal peristalsis waves

    two years

  • The amplitude of intestinal peristalsis waves

    two years

Study Arms (2)

anal dilatation

ACTIVE COMPARATOR
Drug: Lactulose

Oral Lactulose

ACTIVE COMPARATOR
Drug: Lactulose

Interventions

LactuloseDRUG
Oral Lactuloseanal dilatation

Eligibility Criteria

Age1 Month - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants and Children With Constipation
  • Postoperative infants and children with Hirschsprung's disease
  • Good compliance

You may not qualify if:

  • Infants and Children With Constipation
  • Poor compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Constipation

Interventions

Lactulose

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Jiexiong, Feng

    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

September 28, 2014

First Posted

October 3, 2014

Study Start

September 1, 2014

Primary Completion

August 1, 2016

Study Completion

October 1, 2016

Last Updated

October 3, 2014

Record last verified: 2014-09

Locations

CN(1)