Gastrointestinal Tolerance Assessment of T2309

Study Overview
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Brief Summary
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Gastrointestinal Tolerance assessment of T2309 compared to a food supplement in 50 subjects.

Official Title
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Gastrointestinal Tolerance Assessment of T2309

Conditions
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Healthy Adult Subjects

Intervention / Treatment
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* Other: T2309
* Dietary Supplement: Nutrof Total


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T2309<br>4 capsules daily for 12 weeks | Other: T2309<br>* Food for Special Medical Purpose / 4 capsules daily for 12 weeks<br>|
| Active Comparator: Nutrof Total<br>2 capsules daily for 12 weeks | Dietary Supplement: Nutrof Total<br>* 2 capsules daily for 12 weeks<br>* Other names: Food Supplement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 12-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 6 weeks and 12 weeks | 
| Acceptability | Assessed by a self-questionnaire to measure the global satisfaction (4-point scales) | 6 weeks and 12 weeks |