Anal Dilatation for Infants and Children With Constipation

Constipation Clinical Trial

Official title:

Anal Dilatation for Infants and Children With Constipation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02255747
• Other study ID #: Anal Dilatation
• Status: Recruiting
• Phase: N/A
• First received: September 28, 2014
• Last updated: September 30, 2014
• Start date: September 2014
• Est. completion date: October 2016

Study information

• Verified date: September 2014
• Source: Tongji Hospital
• Contact: Zhi Li, MD PhD
• Phone: +8613387664883
• Email: lizhimdphd[@]163.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 14 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• Lactulose

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily stool times		two years	No
Secondary	The frequency of intestinal peristalsis waves		two years	No
Secondary	The amplitude of intestinal peristalsis waves		two years	No