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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01088971

Enrollment

Registered

2010-03-18

Start date

2009-10-31

Completion date

2011-07-31

Last updated

2011-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Brief 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.

Interventions

DIETARY_SUPPLEMENTDuolac7S

1 capsule two times everyday for 6 weeks

DIETARY_SUPPLEMENTstarch

1capsule two times everyday for 6 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

* 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

Design outcomes

Primary

Measure	Time frame	Description
The improvement of IBS symptoms	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).

Secondary

Measure	Time frame
Changes in fecal microflora	baseline and after 6weeks
Changes of biochemical marker	baseline and after 6weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026