NCT02012543

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 16, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

November 4, 2014

Status Verified

November 1, 2014

Enrollment Period

11 months

First QC Date

November 9, 2013

Last Update Submit

November 2, 2014

Conditions

Constipation

Keywords

constipation, agar

Outcome Measures

Primary Outcomes (1)

  • the condition of feces

    Bristol scale is used.

    4 weeks

Secondary Outcomes (1)

  • the number and amount of defecation

    4 weeks

Study Arms (1)

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

Agar jellyDIETARY_SUPPLEMENT
Agar jelly, constipation

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subjects take laxatives.

You may not qualify if:

  • subjects underwent abdominal surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Showa Inan General Hospital

Komagane, Nagano, 399-4117, Japan

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Akira Horiuchi, MD

    Showa Inan General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Digestive Disease Center

Study Record Dates

First Submitted

November 9, 2013

First Posted

December 16, 2013

Study Start

November 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

November 4, 2014

Record last verified: 2014-11

Locations

JP(1)