Gastrointestinal Tolerance Assessment of T2309 (GATA)

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

Study Overview

• Status: Completed
• Conditions: Healthy Adult Subjects
• Intervention / Treatment: Other: T2309; Dietary supplement: Nutrof Total

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France
    • Centre investigation clinique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: T2309; 4 capsules daily for 12 weeks	Other: T2309; Food for Special Medical Purpose / 4 capsules daily for 12 weeks
Active Comparator: Nutrof Total; 2 capsules daily for 12 weeks	Dietary supplement: Nutrof Total; 2 capsules daily for 12 weeks; Other Names: Food Supplement

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Laboratoires Thea

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Actual): March 4, 2021
• Study Completion (Actual): March 4, 2021

Study Registration Dates

• First Submitted: October 14, 2020
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: LT2309-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No