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Anal Dilatation for Infants and Children With Constipation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02255747
Recruitment Status : Unknown
Verified September 2014 by Jiexiong Feng, Tongji Hospital.
Recruitment status was:  Recruiting
First Posted : October 3, 2014
Last Update Posted : October 3, 2014
Sponsor:
Information provided by (Responsible Party):
Jiexiong Feng, Tongji Hospital

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

Condition or disease Intervention/treatment Phase
Constipation Drug: Lactulose Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Anal Dilatation for Infants and Children With Constipation
Study Start Date : September 2014
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Lactulose

Arm Intervention/treatment
Active Comparator: anal dilatation Drug: Lactulose
Active Comparator: Oral Lactulose Drug: Lactulose



Primary Outcome Measures :
  1. Daily stool times [ Time Frame: two years ]

Secondary Outcome Measures :
  1. The frequency of intestinal peristalsis waves [ Time Frame: two years ]
  2. The amplitude of intestinal peristalsis waves [ Time Frame: two years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255747


Contacts
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Contact: Zhi Li, MD PhD +8613387664883 lizhimdphd@163.com

Locations
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China, Hubei
Tongji Hospital Recruiting
Wuhan, Hubei, China, 430030
Contact: Zhi Li, MD PhD    +8613387664883    lizhimdphd@163.com   
Sponsors and Collaborators
Tongji Hospital
Investigators
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Principal Investigator: Jiexiong, Feng Tongji Hospital
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Responsible Party: Jiexiong Feng, Professor, Tongji Hospital
ClinicalTrials.gov Identifier: NCT02255747    
Other Study ID Numbers: Anal Dilatation
First Posted: October 3, 2014    Key Record Dates
Last Update Posted: October 3, 2014
Last Verified: September 2014
Keywords provided by Jiexiong Feng, Tongji Hospital:
infants and children with constipation
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Lactulose
Gastrointestinal Agents