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
NA
55 participants
INTERVENTIONAL
2020-07-15
2021-03-04
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
TREATMENT
NONE
Study Groups
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T2309
4 capsules daily for 12 weeks
T2309
Food for Special Medical Purpose / 4 capsules daily for 12 weeks
Nutrof Total
2 capsules daily for 12 weeks
Nutrof Total
2 capsules daily for 12 weeks
Interventions
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T2309
Food for Special Medical Purpose / 4 capsules daily for 12 weeks
Nutrof Total
2 capsules daily for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
ALL
Yes
Sponsors
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Laboratoires Thea
INDUSTRY
Responsible Party
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Locations
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Centre Investigation Clinique
Nantes, , France
Countries
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Other Identifiers
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LT2309-001
Identifier Type: -
Identifier Source: org_study_id
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