Effect of Agar Administration on Defecation and Fecal Con... | NCT02012543

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

NCT02012543

Sponsor

Showa Inan General Hospital

Status

Completed

Last Update Posted

Nov 4, 2014Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

Constipation

Interventions

Agar jelly

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Kanten1	Other Identifier	Ina Food Industry

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Oct 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Nov 9, 2013

First Submission Date that Met QC Criteria

Dec 10, 2013

First Posted Date

Dec 16, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 2, 2014

Last Update Posted Date

Nov 4, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Akira Horiuchi, Chief, Digestive Disease Center, Showa Inan General HospitalPrincipal Investigator

Lead Sponsor

Showa Inan General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Agar jelly, constipation	Experimental	Subjects eat a cap of agar jelly (180g) shortly before eating dinner every day for 4 weeks.	Dietary Supplement: Agar jelly

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Agar jelly	Dietary Supplement		Agar jelly, constipation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the condition of feces	Bristol scale is used.	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
the number and amount of defecation		4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

subjects take laxatives.

Exclusion Criteria:

subjects underwent abdominal surgery.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Akira Horiuchi, MD	Showa Inan General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Showa Inan General Hospital		Komagane	Nagano	399-4117	Japan

Condition Browse Module

MeSH Terms

ID	Term
D003248	Constipation

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

Not provided