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Effect of Agar Administration on Defecation and Fecal Condition in Chronic Constipated Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02012543
First Posted: December 16, 2013
Last Update Posted: November 4, 2014
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.
Information provided by (Responsible Party):
Akira Horiuchi, Showa Inan General Hospital
  Purpose
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.

Condition Intervention
Constipation Dietary Supplement: Agar jelly

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Akira Horiuchi, Showa Inan General Hospital:

Primary Outcome Measures:
  • the condition of feces [ Time Frame: 4 weeks ]
    Bristol scale is used.


Secondary Outcome Measures:
  • the number and amount of defecation [ Time Frame: 4 weeks ]

Enrollment: 100
Study Start Date: November 2013
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Agar jelly, constipation
Subjects eat a cap of agar jelly (180g) shortly before eating dinner every day for 4 weeks.
Dietary Supplement: Agar jelly

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • subjects take laxatives.

Exclusion Criteria:

  • subjects underwent abdominal surgery.
  Contacts and Locations
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): NCT02012543


Locations
Japan
Showa Inan General Hospital
Komagane, Nagano, Japan, 399-4117
Sponsors and Collaborators
Showa Inan General Hospital
Investigators
Principal Investigator: Akira Horiuchi, MD Showa Inan General Hospital
  More Information

Responsible Party: Akira Horiuchi, Chief, Digestive Disease Center, Showa Inan General Hospital
ClinicalTrials.gov Identifier: NCT02012543     History of Changes
Other Study ID Numbers: Agar jelly
Kanten1 ( Other Identifier: Ina Food Industry )
First Submitted: November 9, 2013
First Posted: December 16, 2013
Last Update Posted: November 4, 2014
Last Verified: November 2014

Keywords provided by Akira Horiuchi, Showa Inan General Hospital:
constipation, agar

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms