The Effects of Multi-strain Probiotics in Adults With Diarrhea Predominant Irritable Bowel Syndrome

Diarrhea Predominant Irritable Bowel Syndrome Clinical Trial

Official title:

The Effects of Multi-strain Probiotics in Adults With Diarrhea Predominant Irritable Bowel Syndrome: Double-blind, Randomized, Placebo-controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01637714
• Other study ID #: Probiotics for IBS
• Status: Recruiting
• Phase: N/A
• First received: June 21, 2012
• Last updated: June 17, 2013
• Start date: July 2012
• Est. completion date: July 2013

Study information

• Verified date: June 2013
• Source: Seoul National University Hospital
• Contact: Joo Sung Kim, M.D., PhD
• Phone: +82-2-740-8112
• Email: jooskim[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators will evaluate the efficacy of multi-strain probiotics in adults with diarrhea predominant irritable bowel syndrome.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 75 Years

Eligibility

Inclusion Criteria:

• willing to consent/undergo necessary procedures

• between the age of 19 and 75 years

• diarrhea predominant irritable bowel syndrome (satisfied with Rome II criteria)

Exclusion Criteria:

• uncontrolled hypertension (Blood pressure > 180/110 mmHg)

• uncontrolled diabetes mellitus (FBS > 200 mg/dL)

• malignancy, cerebrovascular disease, cardiovascular disease

• history of abdominal surgery except appendectomy and hernia repair

• inflammatory bowel disease

• clinically or laboratory-confirmed gastroenteritis

• the use of motility drug or dietary fiber supplement in 2 weeks

• serum Cr > 2 x Upper normal limit

• AST or ALT > 2 x Upper normal limit

• Pregnancy, Lactating woman

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diarrhea
• Diarrhea Predominant Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Multi-strain probiotics
B. longum BORI: 1 x 109 B. bifidum BGN4: 1 x 109 B. lactis AD011: 1 x 109 B. infantis IBS007: 1 x 109 Lactobacillus acidophilus AD031: 1 x 109 three times a day, within 10 minutes after meal, per oral with water
• Placebo powder
same taste, shape, dosage as experimental drug three times a day, within 10 minutes after meal, per oral with water

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of Irritable bowel syndrome symptom severity score (IBS-SSS)	Severity and frequency of abdominal pain / abdominal bloating / bowel habitus / interfere degree of daily life	after 8 weeks	Yes
Secondary	Stool frequency and form	Stool frequency (greater than 3 bowel movements/day or less than 3 bowel movements/week) Stool form (lumpy / hard or loose / watery stool)	after 4 weeks and 8 weeks	Yes
Secondary	Symptom control of irritable bowel syndrome		after 4 weeks and 8 weeks	Yes
Secondary	Improvement of overall symptom in patient with irritable bowel syndrome		after 4 weeks and 8 weeks	Yes
Secondary	Assessment for quality of life related with irritable bowel syndrome		after 4 weeks and 8 weeks	Yes
Secondary	Assessment for patient satisfaction after administration completion		after 4 weeks and 8 weeks	Yes