Healthy Adult SubjectsGATANCT04596605
Gastrointestinal Tolerance Assessment of T2309
A study testing T2309 and Nutrof Total in people with Healthy Adult Subjects, run by Laboratoires Thea at 1 site in France.
Trial summary
Gastrointestinal Tolerance assessment of T2309 compared to a food supplement in 50 subjects. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Subjects
- What is being tested?
- T2309 and Nutrof Total
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2020to 4 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Gastrointestinal Tolerance assessment of T2309 compared to a food supplement in 50 subjects.
- Conditions
- Healthy Adult Subjects
- Being tested
- T2309, Nutrof Total
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T2309Other
Food for Special Medical Purpose / 4 capsules daily for 12 weeks
Nutrof TotalDietary supplement
Also called Food Supplement
2 capsules daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| T2309 | Experimental | 4 capsules daily for 12 weeks Receives: Other: T2309 |
| Nutrof Total | Active comparator | 2 capsules daily for 12 weeks Receives: Dietary Supplement: Nutrof Total |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12-week
Secondary outcomes (3)
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)
Measured: 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)
Measured: 6 weeks and 12 weeks
Acceptability
Assessed by a self-questionnaire to measure the global satisfaction (4-point scales)
Measured: 6 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start15 Jul 2020
- Primary completion4 Mar 2021
- Study completion4 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Thea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596605
- Sponsor's protocol ID
- LT2309-001
- Acronym
- GATA
- Status last verified
- Jul 2021
- First submitted
- 14 Oct 2020
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Tolerance Assessment of T2309
- ClinicalTrials.gov ID
- NCT04596605
- Acronym / sponsor ID
- GATA / LT2309-001
- Conditions
- Healthy Adult Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 4 Mar 2021 (actual)
- Study completion
- 4 Mar 2021 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gastrointestinal Tolerance assessment of T2309 compared to a food supplement in 50 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T2309 | Experimental | Other: T23094 capsules daily for 12 weeks |
| Nutrof Total | Active comparator | Dietary Supplement: Nutrof Total2 capsules daily for 12 weeks |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T2309Food for Special Medical Purpose / 4 capsules daily for 12 weeks | Other | T2309 |
| Nutrof TotalAlso: Food Supplement2 capsules daily for 12 weeks | Dietary supplement | Nutrof Total |
Primary outcome
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)
3 secondary outcomes
Composite score of gastrointestinal tolerance
Time frame: 6 weeks
Each component of the composite score of gastrointestinal tolerance
Time frame: 6 weeks and 12 weeks
Acceptability
Time frame: 6 weeks and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: No
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Healthy Subjects
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T2309 and Nutrof Total in people with Healthy Adult Subjects, run by Laboratoires Thea at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal Tolerance assessment (time frame: 12-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.