Gastrointestinal Tolerance assessment of T2309 compared to a food supplement in 50 subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Food for Special Medical Purpose / 4 capsules daily for 12 weeks
2 capsules daily for 12 weeks
Centre Investigation Clinique
Nantes, France
Gastrointestinal Tolerance assessment
Change from baseline in the mean of the daily composite score of gastrointestinal tolerance assessed with the Bristol Stool Scale (BSS) (composite score of stool frequency and consistency) and 10-point Likert scales filled (sum of the ratings of the 4 gastrointestinal symptoms scores) daily for 1 week prior to the completion of the 12-week treatment period (expressed in arbitrary unit/day (a.u./day), range 0-50)
Time frame: 12-week
Composite score of gastrointestinal tolerance
Change from baseline in the mean of the daily composite score of gastrointestinal tolerance assessed with the BSS and 10-point Likert scales filled daily for 1 week prior to the completion of the 6-week treatment period (a.u./day, range 0-50)
Time frame: 6 weeks
Each component of the composite score of gastrointestinal tolerance
Change from baseline in the mean of each component of the composite score of gastrointestinal tolerance after 6 weeks and 12 weeks of treatment: 4 gastrointestinal symptoms (a.u./day, range 0-10), stool frequency (number of stools/day), stool consistency (a.u./stool, range 1-7)
Time frame: 6 weeks and 12 weeks
Acceptability
Assessed by a self-questionnaire to measure the global satisfaction (4-point scales)
Time frame: 6 weeks and 12 weeks
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