GATA: Gastrointestinal Tolerance Assessment of T2309

• Sponsor: Laboratoires Thea (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04596605
• Collaborator: (none)
• Enrollment: 55
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.6
• Patients Per Site Per Month: 7.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Adult Subjects	Other: T2309; Dietary Supplement: Nutrof Total	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Gastrointestinal Tolerance Assessment of T2309
• Actual Study Start Date: Jul 15, 2020
• Actual Primary Completion Date: Mar 4, 2021
• Actual Study Completion Date: Mar 4, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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)

2. 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)

3. Acceptability [6 weeks and 12 weeks]

   Assessed by a self-questionnaire to measure the global satisfaction (4-point scales)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Investigation Clinique	Nantes		France

Sponsors and Collaborators

• Laboratoires Thea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Laboratoires Thea
• ClinicalTrials.gov Identifier: NCT04596605
• Other Study ID Numbers: LT2309-001
• First Posted: Oct 22, 2020
• Last Update Posted: Jul 28, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 28, 2021