Gastrointestinal Tolerance Assessment of T2309

NCT ID: NCT04596605

Last Updated: 2021-07-28

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-15

Study Completion Date

2021-03-04

Brief Summary

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Gastrointestinal Tolerance assessment of T2309 compared to a food supplement in 50 subjects.

Detailed Description

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Conditions

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Healthy Adult Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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T2309

4 capsules daily for 12 weeks

Group Type EXPERIMENTAL

T2309

Intervention Type OTHER

Food for Special Medical Purpose / 4 capsules daily for 12 weeks

Nutrof Total

2 capsules daily for 12 weeks

Group Type ACTIVE_COMPARATOR

Nutrof Total

Intervention Type DIETARY_SUPPLEMENT

2 capsules daily for 12 weeks

Interventions

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T2309

Food for Special Medical Purpose / 4 capsules daily for 12 weeks

Intervention Type OTHER

Nutrof Total

2 capsules daily for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Food Supplement

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Laboratoires Thea

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Investigation Clinique

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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LT2309-001

Identifier Type: -

Identifier Source: org_study_id

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