Gut HealthNCT06122571
A Clinical Trial to Evaluate the Effect of ConcenTrace Trace Mineral Drops on Gut Health
A study testing ConcenTrace in people with Gut Health and Bowel Movements, run by Trace Minerals at 1 site in United States.
Trial summary
This is a virtual single-arm trial that will last 12 weeks. Participants will take the drops daily and complete questionnaires at Baseline, Week 4, Week 8, and Week 12. Gut health, bowel movements, stool looseness, constipation, bloating, and regularity will be evaluated at the Baseline and at each check-in. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gut Health, Bowel Movements, Constipation
- What is being tested?
- ConcenTrace
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2023to 31 Jan 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be male or female. Be aged over 18. Have a BMI less than 35. Have issues with digestion, heartburn, indigestion, gas, or constipation. Be willing to maintain their standard dietary pattern, activity level, and body weight for the duration of the study.
- Be generally healthy - must not live with any uncontrolled disease.
Who cannot join
- Any person with a pre-existing chronic condition that might prevent the participant from adhering to the protocol, including any oncological and psychiatric disorders.
- Anyone taking any prescribed medication targeting the gut. Anyone taking any supplements targeting the gut within the past month. Anyone with any known severe allergic reactions. Women who are pregnant, breastfeeding, or attempting to become pregnant. Anyone unwilling to follow the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
This is a virtual single-arm trial that will last 12 weeks. Participants will take the drops daily and complete questionnaires at Baseline, Week 4, Week 8, and Week 12. Gut health, bowel movements, stool looseness, constipation, bloating, and regularity will be evaluated at the Baseline and at each check-in. Likert scale responses will be statistically compared from Baseline to each check-in. Participant responses and product feedback will be presented as percentage scores.
- Conditions
- Gut Health, Bowel Movements, Constipation, Bloating
- Being tested
- ConcenTrace
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConcenTraceOther
The product contains concentrated seawater from Utah's inland sea.
| Study group | Role | What they receive |
|---|---|---|
| Test arm: ConcenTrace | Experimental | Participants will follow this weekly dosing schedule:
Week 1: Day 1-3: take 5 drops of ConcenTrace with 8oz of water or flavored water. Day 4-7: take 5 drops of ConcenTrace 2x per day with 8 oz of water or flavored water.
Week 2: Take 10 drops of ConcenTrace 2x per day with 8 oz of water or flavored water.
Week 3: Take 15 drops of ConcenTrace 2x per day with 8 oz of water or flavored water.
Week 4: Take 20 drops of ConcenTrace 2x per day with 8 oz of water or flavored water.
Weeks 5 - 12: Take 40 drops of ConcenTrace 1x per day with 8 oz of water or flavored water. Receives: Other: ConcenTrace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in scores on the Gastrointestinal Symptom Rating Scale (GSRS). [Timeframe: Baseline to Week 12]
The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
Measured: 12 weeks
Secondary outcomes (2)
Changes in stool consistency reported via the Bristol Stool Chart. [Timeframe: Baseline to Week 12]
The Bristol stool scale is a diagnostic medical tool designed to classify the form of human faeces into seven categories. Type 1 has spent the longest time in the bowel and type 7 the least time.
Measured: 12 weeks
Changes in bowel movement frequency. [Timeframe: Baseline to Week 12]
The frequency that the participants have a bowel movement will be recorded via questionnaires.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start5 Oct 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut HealthStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trace Minerals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122571
- Sponsor's protocol ID
- 20351
- Status last verified
- Aug 2024
- First submitted
- 2 Nov 2023
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Effect of ConcenTrace Trace Mineral Drops on Gut Health
- ClinicalTrials.gov ID
- NCT06122571
- Acronym / sponsor ID
- 20351
- Conditions
- Gut Health, Bowel Movements, Constipation, Bloating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Trace MineralsIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 8 Nov 2023 (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.
This is a virtual single-arm trial that will last 12 weeks. Participants will take the drops daily and complete questionnaires at Baseline, Week 4, Week 8, and Week 12. Gut health, bowel movements, stool looseness, constipation, bloating, and regularity will be evaluated at the Baseline and at each check-in. Likert scale responses will be statistically compared from Baseline to each check-in. Participant responses and product feedback will be presented as percentage scores.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test arm: ConcenTrace | Experimental | Other: ConcenTraceParticipants will follow this weekly dosing schedule: Week 1: Day 1-3: take 5 drops of ConcenTrace with 8oz of water or flavored water. Day 4-7: take 5 drops of ConcenTrace 2x per day with 8 oz of water or flavored water. Week 2: Take 10 drops of ConcenTrace 2x per day with 8 oz of water or flavored water. Week 3: Take 15 drops of ConcenTrace 2x per day with 8 oz of water or flavored water. Week 4: Take 20 drops of ConcenTrace 2x per day with 8 oz of water or flavored water. Weeks 5 - 12: Take 40 drops of ConcenTrace 1x per day with 8 oz of water or flavored water. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Be male or female. Be aged over 18. Have a BMI less than 35. Have issues with digestion, heartburn, indigestion, gas, or constipation. Be willing to maintain their standard dietary pattern, activity level, and body weight for the duration of the study.
- Be generally healthy - must not live with any uncontrolled disease.
Key exclusion criteria (2 listed)
- Any person with a pre-existing chronic condition that might prevent the participant from adhering to the protocol, including any oncological and psychiatric disorders.
- Anyone taking any prescribed medication targeting the gut. Anyone taking any supplements targeting the gut within the past month. Anyone with any known severe allergic reactions. Women who are pregnant, breastfeeding, or attempting to become pregnant. Anyone unwilling to follow the study protocol.
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 |
|---|---|---|
| ConcenTraceThe product contains concentrated seawater from Utah's inland sea. | Other | Test arm: ConcenTrace |
Primary outcome
Changes in scores on the Gastrointestinal Symptom Rating Scale (GSRS). [Timeframe: Baseline to Week 12]
Time frame: 12 weeks
The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
2 secondary outcomes
Changes in stool consistency reported via the Bristol Stool Chart. [Timeframe: Baseline to Week 12]
Time frame: 12 weeks
Changes in bowel movement frequency. [Timeframe: Baseline to Week 12]
Time frame: 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 23 Aug 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Gut Health
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Active, not recruiting
SweetSpot - The Effect of Non-nutritive Sweeteners on Health
Healthy Adult
Recruiting
Tiny Tummies - A Milk Study
Gut Microbiome, Neurocognitive Correlates of Eating Habits
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 ConcenTrace in people with Gut Health and Bowel Movements, run by Trace Minerals at 1 site in United States.
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 2 inclusion and 2 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 23 Aug 2024. 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 United States. 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?
Changes in scores on the Gastrointestinal Symptom Rating Scale (GSRS). [Timeframe: Baseline to Week 12] (time frame: 12 weeks). 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 23 Aug 2024.