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Anal Dilatation for Infants and Children With Constipation

Primary Purpose

Constipation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Lactulose
Sponsored by
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring infants and children with constipation

Eligibility Criteria

1 Month - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Infants and Children With Constipation
  2. Postoperative infants and children with Hirschsprung's disease
  3. Good compliance

Exclusion Criteria:

  1. Infants and Children With Constipation
  2. Poor compliance

Sites / Locations

  • Tongji HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

anal dilatation

Oral Lactulose

Arm Description

Outcomes

Primary Outcome Measures

Daily stool times

Secondary Outcome Measures

The frequency of intestinal peristalsis waves
The amplitude of intestinal peristalsis waves

Full Information

First Posted
September 28, 2014
Last Updated
September 30, 2014
Sponsor
Tongji Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02255747
Brief Title
Anal Dilatation for Infants and Children With Constipation
Official Title
Anal Dilatation for Infants and Children With Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
infants and children with constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
anal dilatation
Arm Type
Active Comparator
Arm Title
Oral Lactulose
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Lactulose
Primary Outcome Measure Information:
Title
Daily stool times
Time Frame
two years
Secondary Outcome Measure Information:
Title
The frequency of intestinal peristalsis waves
Time Frame
two years
Title
The amplitude of intestinal peristalsis waves
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Infants and Children With Constipation Postoperative infants and children with Hirschsprung's disease Good compliance Exclusion Criteria: Infants and Children With Constipation Poor compliance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhi Li, MD PhD
Phone
+8613387664883
Email
lizhimdphd@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiexiong, Feng
Organizational Affiliation
Tongji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhi Li, MD PhD
Phone
+8613387664883
Email
lizhimdphd@163.com

12. IPD Sharing Statement

Learn more about this trial

Anal Dilatation for Infants and Children With Constipation

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