GastrointestinalNCT07355634
Terraflora Daily Care and Gastrointestinal Health
A study testing Synbiotic Dietary Supplement in people with Gastrointestinal, run by OvationLab at 1 site in United States.
Trial summary
A 12-week, randomized, double-blind, placebo-controlled clinical trial will be conducted evaluating the effectiveness of Enviromedica - Terraflora Daily Care on markers of gastrointestinal function and symptoms. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Gastrointestinal
- What is being tested?
- Synbiotic Dietary Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males or females age ≥ 25 years
- Ability to read and speak English
- Dysbiosis (≥3 on GA-Map Dysbiosis Score) on a stool test (GI360 Profile, Doctor's Data, St. Charles, Illinois)
Who cannot join
- Daily use within the past month of any probiotic or prebiotic supplement
- Current diagnosis of inflammatory bowel disease, including Crohn's or ulcerative colitis
- Current daily usage of non-steroidal anti-inflammatory drugs (NSAID), proton pump inhibitors (PPI), or antibiotic medications
- Current daily tobacco smoker
- Known allergies to any substance in the study products
- Currently pregnant or lactating women or women planning to become pregnant in the next 12 weeks
Show all 9Show fewer
- Current diagnosis of any other chronic health condition (e.g., cancer, chronic kidney disease) deemed clinically contraindicated for the study protocol
- Current participation in another clinical trial
- Participants unable to provide consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
OvationLab
Richmond, Virginia, 23220
Study Administration, (240) 232-2103, info@ovationlab.com
About this study
Official title: A Randomized, Placebo-Controlled Trial Evaluating the Impact of a Synbiotic Dietary Supplement on Markers of Gastrointestinal Health
A 12-week, randomized, double-blind, placebo-controlled clinical trial will be conducted evaluating the effectiveness of Enviromedica - Terraflora Daily Care on markers of gastrointestinal function and symptoms.
- Conditions
- Gastrointestinal
- Being tested
- Synbiotic Dietary Supplement, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synbiotic Dietary SupplementDietary supplement
12 weeks of supplementation with Enviromedica - Terraflora Daily Care
PlaceboDietary supplement
Placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Terraflora - Daily Care | Experimental | Not described Receives: Dietary Supplement: Synbiotic Dietary Supplement |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
GA-Map Dysbiosis on GI360 Profile
Measured: 4 weeks, 12 weeks
Secondary outcomes (2)
Percentage of participants with dysfunction on GI360 Profile
Measured: 4 weeks, 12 weeks
Gastrointestinal Symptom Rating Scale
Minimum value: 1, Maximum value: 7, Higher scores represent more severe/troublesome symptoms.
Measured: 4 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start12 Jan 2026
- Primary completionJun 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastrointestinalStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OvationLab
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355634
- Sponsor's protocol ID
- ENV-001
- Status last verified
- May 2026
- First submitted
- 2 Jan 2026
- Last updated
- 11 May 2026
- 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 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled Trial Evaluating the Impact of a Synbiotic Dietary Supplement on Markers of Gastrointestinal Health
- ClinicalTrials.gov ID
- NCT07355634
- Acronym / sponsor ID
- ENV-001
- Conditions
- Gastrointestinal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- OvationLabResearch network
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 21 Jan 2026 (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.
A 12-week, randomized, double-blind, placebo-controlled clinical trial will be conducted evaluating the effectiveness of Enviromedica - Terraflora Daily Care on markers of gastrointestinal function and symptoms.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Terraflora - Daily Care | Experimental | Dietary Supplement: Synbiotic Dietary Supplement |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult males or females age ≥ 25 years
- Ability to read and speak English
- Dysbiosis (≥3 on GA-Map Dysbiosis Score) on a stool test (GI360 Profile, Doctor's Data, St. Charles, Illinois)
Key exclusion criteria (9 listed)
- Daily use within the past month of any probiotic or prebiotic supplement
- Current diagnosis of inflammatory bowel disease, including Crohn's or ulcerative colitis
- Current daily usage of non-steroidal anti-inflammatory drugs (NSAID), proton pump inhibitors (PPI), or antibiotic medications
- Current daily tobacco smoker
- Known allergies to any substance in the study products
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 |
|---|---|---|
| Synbiotic Dietary Supplement12 weeks of supplementation with Enviromedica - Terraflora Daily Care | Dietary supplement | Terraflora - Daily Care |
| PlaceboPlacebo capsule | Dietary supplement | Placebo |
Primary outcome
GA-Map Dysbiosis on GI360 Profile
Time frame: 4 weeks, 12 weeks
2 secondary outcomes
Percentage of participants with dysfunction on GI360 Profile
Time frame: 4 weeks, 12 weeks
Gastrointestinal Symptom Rating Scale
Time frame: 4 weeks, 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotic Dietary Supplement in people with Gastrointestinal, run by OvationLab 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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 11 May 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chris D'Adamo, Ph.D. (240-232-2103, chris@ovationlab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GA-Map Dysbiosis on GI360 Profile (time frame: 4 weeks, 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 11 May 2026.