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OpenTrials
Completed

NCT Number: NCT04596605

Gastrointestinal Tolerance Assessment of T2309

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

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Key information

Conditions

Healthy Adult Subjects

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Investigation Clinique

Nantes, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

T2309

Other

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

Nutrof Total

Dietary Supplement

2 capsules daily for 12 weeks

Other names: Food Supplement

Primary outcomes

  1. Gastrointestinal Tolerance assessment

    Time frame: 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 outcomes

  1. Composite score of gastrointestinal tolerance

    Time frame: 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

    Time frame: 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

    Time frame: 6 weeks and 12 weeks

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

Sponsors and collaborators

Lead sponsor

Laboratoires Thea

Industry

Registry information

Acronym: GATA

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 22, 2020
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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