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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Showa Inan General Hospital
Sponsor:
Information provided by (Responsible Party):
Akira Horiuchi, Showa Inan General Hospital
ClinicalTrials.gov Identifier:
NCT02012543
First received: November 9, 2013
Last updated: December 10, 2013
Last verified: December 2013
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Showa Inan General Hospital:

Primary Outcome Measures:
  • the condition of feces [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Bristol scale is used.


Secondary Outcome Measures:
  • the number and amount of defecation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • subjects take laxatives.

Exclusion Criteria:

  • subjects underwent abdominal surgery.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02012543

Contacts
Contact: Akira Horiuchi, M.D. 81265822121 ext 3012 horiuchi.akira@sihp.jp

Locations
Japan
Showa Inan General Hospital Recruiting
Komagane, Nagano, Japan, 399-4117
Contact: Akira Horiuchi, MD    81265822121 ext 3012    horiuchi.akira@sihp.jp   
Principal Investigator: Akira Horiuchi, MD         
Sponsors and Collaborators
Showa Inan General Hospital
Investigators
Principal Investigator: Akira Horiuchi, MD Showa Inan General Hospital
  More Information

No publications provided

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
Study First Received: November 9, 2013
Last Updated: December 10, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Showa Inan General Hospital:
constipation, agar

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

ClinicalTrials.gov processed this record on September 18, 2014