Effect of Lactobacillus Plantarum 299v on Symptoms of Irritable Bowel Syndrome
NCT ID: NCT01886781
Last Updated: 2014-09-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
81 participants
INTERVENTIONAL
2011-01-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lactobacillus plantarum 299v
Lactobacillus plantarum 299v capsules
Lactobacillus plantarum 299v
two capsules of 5 X 10 \^9 c.f.u each
Run in period
Run -in period of one to two weeks. No treatment. Treatment started at baseline following randomization to either L.plantarum 299v or placebo
Wash - out period
Wash - out period following treatment phase of eight weeks
Crytalline cellulose powder
Placebo capsule, filled with micro-crystalline cellulose powder
Placebo comparator
Micro-crystalline cellulose powder, identical taste, texture and appearance
Run in period
Run -in period of one to two weeks. No treatment. Treatment started at baseline following randomization to either L.plantarum 299v or placebo
Wash - out period
Wash - out period following treatment phase of eight weeks
Run in period
Run in period of one to two weeks, no treatment. At baseline randomization and treatment commenced.
No interventions assigned to this group
Wash out period
Wash out period of two weeks, no treatment.
No interventions assigned to this group
Interventions
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Lactobacillus plantarum 299v
two capsules of 5 X 10 \^9 c.f.u each
Placebo comparator
Micro-crystalline cellulose powder, identical taste, texture and appearance
Run in period
Run -in period of one to two weeks. No treatment. Treatment started at baseline following randomization to either L.plantarum 299v or placebo
Wash - out period
Wash - out period following treatment phase of eight weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* availability of at least one colonoscopy within the last three years,
* aged 18 or older at the time of screening,
* provision of written informed consent,
* commitment of availability throughout the 12 week study period.
Exclusion Criteria
* current use of antibiotics,
* history of organic intestinal disease,
* pregnant or breastfeeding mothers,
* chronic infectious disease like HIV or tuberculosis, and
* unable to understand English or Afrikaans.
18 Years
ALL
No
Sponsors
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Nestlè Nutrition Institute Africa
OTHER
National Research Foundation (NRF) (RSA)
UNKNOWN
University of Stellenbosch
OTHER
Responsible Party
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Cheryl Stevenson
Mrs
Principal Investigators
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Cheryl Stevenson, M.Sc
Role: PRINCIPAL_INVESTIGATOR
Univeristy of Stellenbosch
Locations
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Netcare Greenacres Hospital
Port Elizabeth, Eastern Cape, South Africa
Countries
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Other Identifiers
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N10-08-270
Identifier Type: -
Identifier Source: org_study_id
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