Irritable Bowel SyndromePhase 3NCT01088971
Effect of Duolac 7S Administration on Improving Symptom in Irritable Bowel Syndrome
A Phase 3 study testing Duolac7S and starch in people with Irritable Bowel Syndrome, run by Cell Biotech Co., Ltd. at 1 site in South Korea.
Trial summary
Gut microflora-mucosal interactions may be involved in the pathogenesis of irritable bowel syndrome (IBS). The purpose of this study is to investigate the efficacy of Duolac7S in changing the colonic microflora and improve the symptoms in IBS sufferers. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Duolac7S and starch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2009to Jul 2011
- Phase
- Phase 3
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age: 18~65 years
- diarrhea type irritable bowel syndrome (by ROME III criteria)
- no organic bowel disease (by colonoscopy or barium enema)
Who cannot join
- pregnant women or nursing mothers
- hypersensitivity to probiotics
- congestive heart failure or ischemic heart disease
- systolic blood pressure : more than 160 mmHg or diastolic blood pressure: more than 100 mmHg
- uncontrolled diabetes mellitus, secondary dyslipidemia, hyperthyroidism, or hypothyroidism
- abdominal surgery (exception: appendectomy, hernia surgery)
- more than moderate alcohol drinking
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University College of Medicine, Gangnam Severance Hospital
Seoul, Seoul, 135-720
About this study
Gut microflora-mucosal interactions may be involved in the pathogenesis of irritable bowel syndrome (IBS). The purpose of this study is to investigate the efficacy of Duolac7S in changing the colonic microflora and improve the symptoms in IBS sufferers. In all, 64 patients with Rome III positive diarrhea type IBS will complete a 6-week multiple centre controlled clinical trial. Patients will be randomized to receive either 2 capsules/day Duolac7S or 2 capsules/day placebo. IBS symptoms will be monitored and scored according to Likert scale. Changes in faecal microflora, stool frequency and form, quality of life (QOL) scores will be also monitored.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Duolac7S, starch
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duolac7SDietary supplement
1 capsule two times everyday for 6 weeks
starchDietary supplement
1capsule two times everyday for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Duolac 7S | Active comparator | Not described Receives: Dietary Supplement: Duolac7S |
| starch capsule | Placebo comparator | Not described Receives: Dietary Supplement: starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
The improvement of IBS symptoms
IBS symptoms were recorded on diary cards every evening during the treatment periods. Abdominal pain, discomfort,urgency and bloating were recorded (score 0-10); stool frequency as number of stools per day; stool consistency according to Bristol stool scale form (score 1-7).
Measured: 6 weeks (symptom diary and weekly questionnaire)
Secondary outcomes (2)
Changes in fecal microflora
Measured: baseline and after 6weeks
Changes of biochemical marker
Measured: baseline and after 6weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
- Study startOct 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cell Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088971
- Sponsor's protocol ID
- CellBiotech
- Status last verified
- Dec 2011
- First submitted
- 7 Mar 2010
- Last updated
- 23 Dec 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Duolac 7S Administration on Improving Symptom in Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT01088971
- Acronym / sponsor ID
- CellBiotech
- Conditions
- Irritable Bowel Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cell Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 18 Mar 2010 (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.
Gut microflora-mucosal interactions may be involved in the pathogenesis of irritable bowel syndrome (IBS). The purpose of this study is to investigate the efficacy of Duolac7S in changing the colonic microflora and improve the symptoms in IBS sufferers. In all, 64 patients with Rome III positive diarrhea type IBS will complete a 6-week multiple centre controlled clinical trial. Patients will be randomized to receive either 2 capsules/day Duolac7S or 2 capsules/day placebo. IBS symptoms will be monitored and scored according to Likert scale. Changes in faecal microflora, stool frequency and form, quality of life (QOL) scores will be also monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duolac 7S | Active comparator | Dietary Supplement: Duolac7S |
| starch capsule | Placebo comparator | Dietary Supplement: starch |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age: 18~65 years
- diarrhea type irritable bowel syndrome (by ROME III criteria)
- no organic bowel disease (by colonoscopy or barium enema)
Key exclusion criteria (7 listed)
- pregnant women or nursing mothers
- hypersensitivity to probiotics
- congestive heart failure or ischemic heart disease
- systolic blood pressure : more than 160 mmHg or diastolic blood pressure: more than 100 mmHg
- uncontrolled diabetes mellitus, secondary dyslipidemia, hyperthyroidism, or hypothyroidism
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 |
|---|---|---|
| Duolac7S1 capsule two times everyday for 6 weeks | Dietary supplement | Duolac 7S |
| starch1capsule two times everyday for 6 weeks | Dietary supplement | starch capsule |
Primary outcome
The improvement of IBS symptoms
Time frame: 6 weeks (symptom diary and weekly questionnaire)
IBS symptoms were recorded on diary cards every evening during the treatment periods. Abdominal pain, discomfort,urgency and bloating were recorded (score 0-10); stool frequency as number of stools per day; stool consistency according to Bristol stool scale form (score 1-7).
2 secondary outcomes
Changes in fecal microflora
Time frame: baseline and after 6weeks
Changes of biochemical marker
Time frame: baseline and after 6weeks
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 23 Dec 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Duolac7S and starch in people with Irritable Bowel Syndrome, run by Cell Biotech Co., Ltd. at 1 site in South Korea.
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 3 inclusion and 7 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 23 Dec 2011. 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 South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 improvement of IBS symptoms (time frame: 6 weeks (symptom diary and weekly questionnaire)). 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 23 Dec 2011.