Terraflora Daily Care and Gastrointestinal Health
Purpose
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.
Condition
- Gastrointestinal
Eligibility
- Eligible Ages
- Over 25 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Adult males or females age ≥ 25 years 2. Ability to read and speak English 3. Dysbiosis (≥3 on GA-Map Dysbiosis Score) on a stool test (GI360 Profile, Doctor's Data, St. Charles, Illinois)
Exclusion Criteria
- Daily use within the past month of any probiotic or prebiotic supplement 2. Current diagnosis of inflammatory bowel disease, including Crohn's or ulcerative colitis 3. Current daily usage of non-steroidal anti-inflammatory drugs (NSAID), proton pump inhibitors (PPI), or antibiotic medications 4. Current daily tobacco smoker 5. Known allergies to any substance in the study products 6. Currently pregnant or lactating women or women planning to become pregnant in the next 12 weeks 7. Current diagnosis of any other chronic health condition (e.g., cancer, chronic kidney disease) deemed clinically contraindicated for the study protocol 8. Current participation in another clinical trial 9. Participants unable to provide consent
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Other
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Terraflora - Daily Care |
|
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
OvationLab
Richmond, Virginia 23220
Richmond, Virginia 23220
More Details
- Status
- Recruiting
- Sponsor
- OvationLab