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

Seoul National University

Status: Unknown

Conditions: Diarrhea Predominant Irritable Bowel Syndrome

Treatments: Drug: Placebo powder; Drug: Multi-strain probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT01637714

Probiotics for IBS

Details and patient eligibility

About

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

Enrollment: 70 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

Multi-strain probiotics

Experimental group

Treatment:

Drug: Multi-strain probiotics

Placebo powder

Placebo Comparator group

Treatment:

Drug: Placebo powder