- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02012543
Effect of Agar Administration on Defecation and Fecal Condition in Chronic Constipated Patients
November 2, 2014 updated by: Akira Horiuchi, Showa Inan General Hospital
The administration of agar jelly may increase the number of defecation and the volume of feces, and then may improve fecal condition in chronic constipated patients.
Study Overview
Detailed Description
Each subject eats one cap of agar jelly shortly before having dinner every day for 4 weeks.
At 0, 7th, 14th, 21th, and 28th day , the frequency of defecation and defecation condition is assessed.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nagano
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Komagane, Nagano, Japan, 399-4117
- Showa Inan General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- subjects take laxatives.
Exclusion Criteria:
- subjects underwent abdominal surgery.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Agar jelly, constipation
Subjects eat a cap of agar jelly (180g) shortly before eating dinner every day for 4 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the condition of feces
Time Frame: 4 weeks
|
Bristol scale is used.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the number and amount of defecation
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Akira Horiuchi, MD, Showa Inan General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
November 9, 2013
First Submitted That Met QC Criteria
December 10, 2013
First Posted (Estimate)
December 16, 2013
Study Record Updates
Last Update Posted (Estimate)
November 4, 2014
Last Update Submitted That Met QC Criteria
November 2, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Agar jelly
- Kanten1 (Other Identifier: Ina Food Industry)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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