Gastrointestinal Tolerance Assessment of T2309

NCT04596605 | Completed

• 1 other identifier: LT2309-001
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Adult Subjects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Composite score of gastrointestinal tolerance

  6 weeks

• Each component of the composite score of gastrointestinal tolerance

  6 weeks and 12 weeks

• Acceptability

  6 weeks and 12 weeks

Study Arms (2)

T2309

EXPERIMENTAL

4 capsules daily for 12 weeks

Other: T2309

Nutrof Total

ACTIVE COMPARATOR

2 capsules daily for 12 weeks

Dietary Supplement: Nutrof Total

Interventions

T2309 OTHER

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

T2309

Nutrof Total DIETARY_SUPPLEMENT

2 capsules daily for 12 weeks

Also known as: Food Supplement

Nutrof Total

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratoires Thea: lead

Study Sites (1)

Centre Investigation Clinique

Nantes, France

Location

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 22, 2020
• Study Start: July 15, 2020
• Primary Completion: March 4, 2021
• Study Completion: March 4, 2021
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)