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CompletedNCT01088971Updated Dec 23, 2011

Effect of Duolac 7S Administration on Improving Symptom in Irritable Bowel Syndrome

A Phase 3 interventional study of Duolac7S and starch in Irritable Bowel Syndrome, sponsored by Cell Biotech Co., Ltd.. Completed at 1 site in South Korea. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-12-23.

Sponsored by Cell Biotech Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Irritable Bowel Syndrome
03

In context

Irritable Bowel Syndrome

1,084 studies on the registry are indexed under Irritable Bowel Syndrome; 196 are open to participants now.

This study's enrollment of 60 is below the median of 70 across 869 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

This is the only study on the registry with Cell Biotech Co., Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age: 18\~65 years
  • diarrhea type irritable bowel syndrome (by ROME III criteria)
  • no organic bowel disease (by colonoscopy or barium enema)

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Duolac 7S

    Dietary Supplement: Duolac7S

  • Placebo comparator
    starch capsule

    Dietary Supplement: starch

Interventions

  • Dietary supplementDuolac7S

    1 capsule two times everyday for 6 weeks

  • Dietary supplementstarch

    1capsule two times everyday for 6 weeks

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 6 weeks (symptom diary and weekly questionnaire)

Secondary outcomes

  1. Changes in fecal microflora

    Time frame: baseline and after 6weeks

  2. Changes of biochemical marker

    Time frame: baseline and after 6weeks

07

Study locations

1 site
  • Yonsei University College of Medicine, Gangnam Severance Hospital
    Seoul, Seoul 135-720, South Korea
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2009, a primary completion of Jul 2011 and a completion of Jul 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 7, 2010
First posted
Mar 18, 2010
Start
Oct 2009
Primary completionActual
Jul 2011
CompletionActual
Jul 2011
Last update
Dec 23, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 23, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01088971
Lead sponsor
Cell Biotech Co., Ltd.
Responsible party
Sponsor
First posted
Mar 18, 2010
Start date
Oct 2009
Primary completion
Jul 2011
Completion
Jul 2011
Last update
Dec 23, 2011
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

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