Gastrointestinal Tolerance Assessment of T2309

Healthy Adult Subjects Clinical Trial

— GATA  

Official title:

Gastrointestinal Tolerance Assessment of T2309

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04596605
• Other study ID #: LT2309-001
• Status: Completed
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: March 4, 2021

Study information

• Verified date: July 2021
• Source: Laboratoires Thea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 4, 2021
• Est. primary completion date: March 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Adult Subjects

Intervention

Other:
• T2309
Food for Special Medical Purpose / 4 capsules daily for 12 weeks

Dietary Supplement:
• Nutrof Total
2 capsules daily for 12 weeks

Locations

Country	Name	City	State
France	Centre Investigation Clinique	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Thea

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Acceptability	Assessed by a self-questionnaire to measure the global satisfaction (4-point scales)	6 weeks and 12 weeks