Healthy Adult Subjects
Conditions
Brief summary
Gastrointestinal Tolerance assessment of T2309 compared to a food supplement in 50 subjects.
Interventions
OTHERT2309
Food for Special Medical Purpose / 4 capsules daily for 12 weeks
DIETARY_SUPPLEMENTNutrof Total
2 capsules daily for 12 weeks
Sponsors
Laboratoires Thea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Informed consent signed and dated * Volunteer with no history of gastrointestinal disorders * Volunteer agreeing not to consume a food supplement other than IP during the study period * Registered, or agreeing to be registered, in the National Registry of Healthy Volunteers
Exclusion criteria
* Any known or suspected hypersensitivity or allergy * History of or active severe chronic disease or relevant systemic condition incompatible with the study * Pregnancy or breast-feeding or have planned pregnancy in the next 4 months * Childbearing potential woman neither surgically sterilized nor using an adequate contraception * Inability of the subject to understand the study procedures or to give informed consent * Non-compliant subject * Participation in this study at the same time as another clinical investigation/study * Subject having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros * Subject being institutionalized because of legal or regulatory order, inmate of psychiatric wards, prison or state institutions, or employee of the study site or of the Sponsor's company * Subject not covered by the government health care scheme of the country in which he/she is living * Subject with previous, current or anticipated prohibited treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal Tolerance assessment | 12-week | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite score of gastrointestinal tolerance | 6 weeks | 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) |
| Each component of the composite score of gastrointestinal tolerance | 6 weeks and 12 weeks | 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) |
| Acceptability | 6 weeks and 12 weeks | Assessed by a self-questionnaire to measure the global satisfaction (4-point scales) |
Countries
France
Outcome results
None listed