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Completed

NCT Number: NCT01088971

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

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Yonsei University College of Medicine, Gangnam Severance Hospital

Seoul, 135-720, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Duolac7S

Dietary Supplement

1 capsule two times everyday for 6 weeks

starch

Dietary Supplement

1capsule two times everyday for 6 weeks

Primary outcomes

  1. 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).

Secondary outcomes

  1. Changes in fecal microflora

    Time frame: baseline and after 6weeks

  2. Changes of biochemical marker

    Time frame: baseline and after 6weeks

Sponsors and collaborators

Lead sponsor

Cell Biotech Co., Ltd.

Industry

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 18, 2010
Registry last updated
Dec 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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