Effect of Bifidobacterium Lactis HN019 on Colonic Transit Time and Digestive Symptoms
NCT ID: NCT01171014
Last Updated: 2010-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
100 participants
INTERVENTIONAL
2009-06-30
2009-12-31
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
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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High dose probiotic
Bifidobacterium lactis HN019, 10 billion cfu/day
Bifidobacterium lactis HN019
Bifidobacterium lactis HN019, 10 billion cfu/day, once a day for 14 days
Low dose probiotic
Bifidobacterium lactis HN019, 1 billion cfu/day
Bifidobacterium lactis HN019
Bifidobacterium lactis HN019, 1 billion cfu/day, once a day for 14 days
Placebo
Placebo
Placebo
Placebo, once a day for 14 days
Interventions
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Bifidobacterium lactis HN019
Bifidobacterium lactis HN019, 10 billion cfu/day, once a day for 14 days
Bifidobacterium lactis HN019
Bifidobacterium lactis HN019, 1 billion cfu/day, once a day for 14 days
Placebo
Placebo, once a day for 14 days
Eligibility Criteria
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Inclusion Criteria
* stool type 2-4 on the Bristol Stool Chart
* 1 to 3 bowel movements per week
Exclusion Criteria
* major chronic and uncontrolled systemic medical conditions
* severe gastrointestinal conditions known to prolong CTT
* lactose intolerance
* chronic diarrhea
* gastric bypass surgery or lap band insertion for weight loss
* regular laxative use
* pregnant or breast-feeding women
25 Years
65 Years
ALL
Yes
Sponsors
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Danisco
INDUSTRY
Sprim Advanced Life Sciences
OTHER
Fonterra Research Centre
INDUSTRY
Responsible Party
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Fonterra Research Centre
Principal Investigators
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Philip Waller, MD
Role: PRINCIPAL_INVESTIGATOR
Accurate Clinical Research, Houston, TX
Other Identifiers
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#08-SPUS-o6-FON-01
Identifier Type: -
Identifier Source: org_study_id
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