ConstipationNCT02012543
Effect of Agar Administration on Defecation and Fecal Condition in Chronic Constipated Patients
A study testing Agar jelly in people with Constipation, run by Showa Inan General Hospital at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Constipation
- What is being tested?
- Agar jelly
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2013to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects take laxatives.
Who cannot join
- subjects underwent abdominal surgery.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Constipation
- Being tested
- Agar jelly
- Keywords
- constipation, agar
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Agar jellyDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Agar jelly, constipation | Experimental | Subjects eat a cap of agar jelly (180g) shortly before eating dinner every day for 4 weeks. Receives: Dietary Supplement: Agar jelly |
What is being measured
The primary outcome is the main question the study is designed to answer.
the condition of feces
Bristol scale is used.
Measured: 4 weeks
Secondary outcomes (1)
the number and amount of defecation
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Showa Inan General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akira Horiuchi, Showa Inan General Hospital
- Investigators
- Akira Horiuchi, MD, Principal investigator, Showa Inan General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012543
- Sponsor's protocol ID
- Agar jelly
- Other IDs
- Kanten1
- Status last verified
- Nov 2014
- First submitted
- 9 Nov 2013
- Last updated
- 4 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Agar Administration on Defecation and Fecal Condition in Chronic Constipated Patients
- ClinicalTrials.gov ID
- NCT02012543
- Acronym / sponsor ID
- Agar jelly
- Conditions
- Constipation
- Keywords
- constipation, agar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Showa Inan General HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 16 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Agar jelly, constipation | Experimental | Dietary Supplement: Agar jellySubjects eat a cap of agar jelly (180g) shortly before eating dinner every day for 4 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- subjects take laxatives.
Key exclusion criteria (1 listed)
- subjects underwent abdominal surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Agar jelly | Dietary supplement | Agar jelly, constipation |
Primary outcome
the condition of feces
Time frame: 4 weeks
Bristol scale is used.
1 secondary outcome
the number and amount of defecation
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akira Horiuchi, MD principal investigator
Showa Inan General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Agar jelly in people with Constipation, run by Showa Inan General Hospital at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the condition of feces (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2014.