This study will investigate the effects of 4-week probiotic supplementation on whole gut transit time and gastrointestinal symptoms in adults with functional constipation.
This prospective, double-blind, randomized, placebo-controlled clinical trial will investigate the effects of 4-week B. lactis HN019 supplementation on whole gut transit time and gastrointestinal symptoms in adults with functional constipation. Participants who meet all study entry criteria will enter a 2-week run-in period. Following successful completion of the run-in period, subjects will be randomized to 4-week supplementation with B. lactis HN019 (10 billion cfu), B. lactis HN019 (1 billion cfu), or placebo. The primary outcome of whole gut transit time will be evaluated with abdominal x-rays on days 0 and 28. Secondary outcomes include IBS-specific questionnaires (administered on days 0 and 28); abdominal pain severity, bowel movement frequency, stool consistency, and adverse events (evaluated daily throughout the study); and overall product satisfaction (evaluated at day 28). Physical activity questionnaires and 24-hour food recalls will be completed periodically during the trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
224
Capsule containing 10 billion cfu B. lactis HN019 once a day
Capsule containing 1 billion cfu B. lactis HN019 once a day
Capsule containing no probiotic once a day
Arrowhead Family Health Center
Glendale, Arizona, United States
Diagnamics, Inc.
Encinitas, California, United States
Digestive & Liver Disease Specialists
Garden Grove, California, United States
Whole Gut Transit Time
The primary endpoint of this clinical trial is whole gut transit time, which will be assessed using abdominal x-rays on days 0 and 28
Time frame: 4 weeks
Patient Assessment of Constipation Symptoms (PAC-SYM)
The PAC-SYM tool asks 12 questions on the symptoms of constipation. Subjects will complete the PAC-SYM at days 0 and 28.
Time frame: 4 weeks
Patient Assessment of Constipation QoL (PAC-QoL)
The PAC-QoL is a 28-question survey that asks questions on their quality of life.
Time frame: 4 weeks
Bowel Function Index
The Bowel Function Index is a 3-question tool that asks subjects if they have experienced adequate relief of constipation symptoms over the past week. The Bowel Function Index will be completed at days 0 and 28.
Time frame: 4 weeks
Adequate Relief of Constipation (Yes/no)
Adequate relief of constipation (yes/no) This (yes/no) questionnaire will be completed at days 0 and 28.
Time frame: 4 weeks
Bowel Movement Frequency
Subjects will record the number of defecations per day in a diary.
Time frame: 4 weeks
Stool Consistency
Stool consistency will be rated each day in a diary by using the Bristol Stool Scale Form
Time frame: 4 weeks
Overall Product Satisfaction
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StayWell Research
Northridge, California, United States
Sprim ALS
San Francisco, California, United States
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Westlake Village, California, United States
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Carrollton, Texas, United States
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Dallas, Texas, United States
Discovery Clinical Trials South Main
Houston, Texas, United States
Research Across America
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...and 2 more locations
At the end of the supplementation period, subjects will be asked to rate their overall satisfaction with the study product's ability to relieve their constipation symptoms on a 5-point ordinal scale
Time frame: 4 weeks
Adverse Event Frequency
All adverse events, regardless of relationship with investigational product, will be reported during the 4-week follow-up period.
Time frame: 4 weeks